tag:blogger.com,1999:blog-16530020399217496252024-03-12T18:03:10.306-04:00PBIRx PBIRx offers objective solutions to manage pharmacy benefit trends by developing a plan which will be cost effective and service oriented to the specific needs of the client.PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.comBlogger140125tag:blogger.com,1999:blog-1653002039921749625.post-26862977493812284702020-08-21T13:12:00.000-04:002020-08-21T13:12:14.375-04:00<p> </p><p align="center" class="MsoNormal" style="margin-left: .5in; text-align: center; text-indent: -.25in;"><b><span style="font-family: "Arial",sans-serif; font-size: 14.0pt; line-height: 107%;">PLAN AHEAD FOR THE 2020-2021 FLU SEASON <o:p></o:p></span></b></p>
<p class="MsoNormal" style="text-align: justify;"><span style="font-family: "Arial",sans-serif;">“Not getting a
vaccine is like not wearing a mask”, <span style="background: white; color: #222222;">said Dr. Randy Bergen, clinical lead for Kaiser Permanente Northern
California flu vaccine program.<o:p></o:p></span></span></p>
<p class="MsoNormal" style="text-align: justify;"><span style="font-family: "Arial",sans-serif;">Depending on
how well manufacturers of flu vaccines are able to predict which viral strains
will be most prevalent in the upcoming season, a flu shot does not always
guarantee full immunity. Even so, amid the COVID-19 pandemic, it is more
important than ever to be vaccinated, especially in vulnerable populations.
Vaccine manufacturers are expecting a 15% increase in vaccination rates
compared to last year. <o:p></o:p></span></p>
<p class="MsoNormal" style="text-align: justify;"><span style="font-family: "Arial",sans-serif;">The
"recurring mutations" of the influenza virus make it
impossible to create a vaccine that will be effective against every strain of
the flu. Each season's flu shot is composed of the most frequent strains
isolated in the previous season. Studies show that vaccination reduces the risk
of illness by 40% to 60% when the flu viruses circulating are
well-matched to the vaccine, according to the CDC.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-family: "Arial",sans-serif;">There are many
different types of vaccines:<o:p></o:p></span></p><div style="text-align: left;"><span style="font-family: "Arial",sans-serif;">1)Trivalent vaccines, for those 65 years and older include:<br /></span><span style="font-family: "Arial",sans-serif;"><span> a) Fluad<br /></span></span><span style="font-family: "Arial",sans-serif;"><span><span> b) Fluzone High Dose<br /></span></span></span><span style="font-family: "Arial",sans-serif;"><span><span>2) Quadrivalent vaccines, for those 6 months of age and older, include:<br /></span></span></span><span style="font-family: "Arial",sans-serif;"><span><span><span> a) Afluria<br /></span></span></span></span><span style="font-family: "Arial",sans-serif;"><span><span><span><span> b) Fluarix<br /></span></span></span></span></span><span style="font-family: "Arial",sans-serif;"><span><span><span><span><span> c) Fulavel<br /></span></span></span></span></span></span><span style="font-family: "Arial",sans-serif;"><span><span><span><span><span><span> d) Fluzone<br /></span></span></span></span></span></span></span><span style="font-family: "Arial",sans-serif;"><span><span><span><span><span><span>3) Flucelvax, for ages 4 and up<br /></span></span></span></span></span></span></span><span style="font-family: "Arial",sans-serif;"><span><span><span><span><span><span>4) Flublok, egg-free for those 18 years and up<br /></span></span></span></span></span></span></span><span style="font-family: "Arial",sans-serif;"><span><span><span><span><span><span>5) Flumist, a Live Nasal vaccine, for ages 2 to 49</span></span></span></span></span></span></span></div><p class="MsoNormal" style="text-align: justify;"><span style="font-family: Arial, sans-serif;">The CDC
estimates that influenza has resulted in between 140,000 to 810,000
hospitalizations and between 12,000 to 61,000 deaths in the United States,
annually since 2010. Fortunately, due to social distancing and mask-wearing
this year, countries in the Southern Hemisphere that have their winter during
the Northern Hemisphere’s summer, such as Argentina and New Zealand, have already
seen an unprecedented drop in their flu cases in May and June.</span></p>
<p class="MsoNormal" style="text-align: justify;"><span style="font-family: "Arial",sans-serif;">The 2020-2021
vaccine should be widely available by September, though the CDC recommends that
people get a flu vaccine by the end of October, because it takes two weeks for the
immune system to develop antibodies and provide protection. (Flu season
typically runs from late October through early April.) Getting vaccinated later
can still be beneficial and vaccination should continue to be offered
throughout the flu season, even into January or later. Getting vaccinated early
(in July or August) is likely to be associated with diminished protection
against flu infection later in the flu season, particularly among older adults.<span style="mso-spacerun: yes;"> </span>Be sure to contact your physician or pharmacist
for additional information.<o:p></o:p></span></p><p class="MsoNormal"><span style="font-family: arial;"><a href="https://www.cdc.gov/flu/prevent/keyfacts.htm">https://www.cdc.gov/flu/prevent/keyfacts.htm</a><o:p></o:p></span></p><p class="MsoNormal"><span style="font-family: arial;"><a href="https://www.sfgate.com/news/article/Not-getting-a-flu-vaccine-is-like-not-wearing-15473514.php">https://www.sfgate.com/news/article/Not-getting-a-flu-vaccine-is-like-not-wearing-15473514.php</a><o:p></o:p></span></p><p class="MsoNormal"><span style="font-family: arial;"><a href="https://www.usatoday.com/story/news/factcheck/2020/08/16/fact-check-flu-vaccine-hasnt-eradicated-virus-but-has-reduced-burden/3319252001/">https://www.usatoday.com/story/news/factcheck/2020/08/16/fact-check-flu-vaccine-hasnt-eradicated-virus-but-has-reduced-burden/3319252001/</a><o:p></o:p></span></p><p class="MsoNormal">
</p><p class="MsoNormal"><a href="https://www.usatoday.com/story/news/health/2020/08/17/covid-19-and-flu-season-the-overlap-could-overwhelm-hospitals/5582893002/"><span style="font-family: arial;">https://www.usatoday.com/story/news/health/2020/08/17/covid-19-and-flu-season-the-overlap-could-overwhelm-hospitals/5582893002/</span></a><o:p></o:p></p><p class="MsoNormal"><span style="font-family: "Arial",sans-serif;"><br /></span></p>PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com3tag:blogger.com,1999:blog-1653002039921749625.post-69319574090205092242020-04-28T14:07:00.001-04:002020-04-28T14:07:39.488-04:00COVID-19 ANTIBODY VERSUS DIAGNOSTIC TESTING<br />
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">One of the main challenges in response to the COVID-19
pandemic has been testing. <i>Diagnostic</i> tests can confirm if someone has an
active COVID-19 disease, whereby <i>antibody</i> tests confirm if someone
previously had the disease and has developed immunity. Numerous diagnostic
tests have been developed to improve the accuracy, shorten the time required to
produce results, and make the process to obtain a sample less invasive. Abbott
has produced a diagnostic test that requires only 5 minutes and a sample from
the nostril, which is faster and less obtrusive than previous tests obtained
from nasopharyngeal samples. Diagnostic tests allow medical providers to make a
differential diagnosis, recommend self-quarantine and pursue supportive care
measures. Recent CDC statistics estimate nearly 5 million people have been
tested for COVID-19 in the United States. <o:p></o:p></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><br /></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Another significant type of testing is serology testing. Dr.
Redfield, the CDC Director, has said that these tests will be an essential part
of the United States plan to move forward. The purpose of serological tests is
to determine the presence of antibodies in the blood. Antibodies develop as
part of an immune response to infection, as opposed to diagnostic testing which
aims to detect the presence of a disease-causing agent, known as an antigen. Serological
tests can provide insight into how many asymptomatic people have been
previously exposed to the virus and have developed antibodies to fend off
infection, and possibly prevent new infections. The presence of these
antibodies may suggest people could return to work in a safe manner. <o:p></o:p></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><br /></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">The National Institutes of Health (NIH) has launched a study
utilizing antibody testing in over 10,000 people to quantify undetected cases
of COVID-19. Quantifying asymptomatic cases and those that have immunity may
shed light into the degree of virility and transmissibility of the virus. Therapeutically,
serological tests may be utilized to determine who can donate blood that can be
used to manufacture convalescent plasma as a possible treatment for critically
ill patients with COVID-19.<o:p></o:p></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Epidemiologists often reference “herd immunity” when
discussing communicable diseases. Herd immunity is an indirect protection from
infectious disease that occurs when a large percentage of a population has
become immune to an infection. Thus, providing a measure of protection for
individuals who are not immune. How contagious a virus is determines what
percentage of people need to be immune to achieve herd immunity. To put it into
context, measles requires a minimum of 92% of a population to be immune to
prevent its spread. Laboratory data has indicated SARS-CoV-2 is not as
contagious as measles. Thus, according to researchers at Johns Hopkins
University, if 70% of a population is immune to COVID-19, herd immunity may be
achieved. <o:p></o:p></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">There are still several questions that remain regarding
antibodies and immunity against SARS-CoV-2. The length of immunity is unknown and
may play a crucial role in establishing guidelines for reopening the economy, relaxing
social distancing requirements, better understanding the immune response to the
virus, and vaccine development. Length of immunity can vary widely as observed previously
with other viral infections. For example, immunity to the common cold can be as
short as a few months, while protective antibodies against the virus that
caused the SARS outbreak in 2003 are still present in people almost two decades
later. The length of immunity will help to model a potential vaccine schedule
like an annual flu shot or a tetanus vaccine administered every ten years. <o:p></o:p></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">The immune system develops several different types of
antibodies in response to an infection; however, it remains to be determined which
antibodies should be the primary focus. IgM is typically the first antibody
produced by the immune system, followed by IgG. Testing for IgM can indicate a
more recent infection, while the presence of IgG may be a better indicator of sustained
immunity. A potential area of concern is that if a person is tested shortly
after coming in contact with the virus and has not yet had time to develop
antibodies, test results may indicate a false negative. It is not currently
known how long antibodies will remain present in the body after the infection
has been resolved. <o:p></o:p></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><br /></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">The FDA has authorized an expedited process for the many
antibody tests in an effort to increase accessibility. Only four of the -more
than 90 antibody tests now on the market in the U.S. have gone through vetting
through the Emergency Use Authorization (EUA) process. The biggest concern is
that tests may not have a high level of specificity; they may return false
positives when someone has developed antibodies for other viruses. Due to the
variables and current limitations of antibody tests, the FDA has issued recommendations
to health care providers -not to use these antibody tests as the sole basis to diagnose
COVID-19, but rather as information about possible prior exposure. <o:p></o:p></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><br /></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">In the constantly evolving battle against COVID-19,
serological tests will provide an essential tool for scientists and medical
professionals as more data is compiled and tests become more refined.<o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><a href="https://www.medicinenet.com/what_antibody_testing_tells_us_about_covid-19-news.htm?ecd=mnl_day_042120">https://www.medicinenet.com/what_antibody_testing_tells_us_about_covid-19-news.htm?ecd=mnl_day_042120</a><span class="MsoHyperlink"><o:p></o:p></span></span></div>
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<br /></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><a href="https://covidtracking.com/data/us-daily">https://covidtracking.com/data/us-daily</a><span class="MsoHyperlink"><o:p></o:p></span></span></div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><a href="https://www.medicinenet.com/coronavirus_herd_immunity_antibody_test_accuracy-news.htm?ecd=mnl_day_042420">https://www.medicinenet.com/coronavirus_herd_immunity_antibody_test_accuracy-news.htm?ecd=mnl_day_042420</a><o:p></o:p></span></div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><a href="https://www.healthline.com/health/serology">https://www.healthline.com/health/serology</a><o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><a href="https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html">https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/testing.html</a><o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><a href="https://www.fiercebiotech.com/medtech/fda-officially-authorizes-its-first-serological-antibody-blood-test-for-covid-19">https://www.fiercebiotech.com/medtech/fda-officially-authorizes-its-first-serological-antibody-blood-test-for-covid-19</a><span class="MsoHyperlink"><o:p></o:p></span></span></div>
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<br /></div>
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<a href="https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests-covid-19-letter-health-care-providers"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-antibody-tests-covid-19-letter-health-care-providers</span></a><o:p></o:p></div>
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PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com1tag:blogger.com,1999:blog-1653002039921749625.post-81662679935319712682020-04-23T11:22:00.000-04:002020-04-23T11:22:34.626-04:00Impact of Coronavirus on Prescriptions<br />
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><span style="background: white; font-size: 11pt;">During
the Coronavirus pandemic insurance companies and pharmacy benefit managers have
executed many allowances for prescriptions, including relaxation of “Refill too
soon” edits, 60-day extension of existing prior authorizations, and allowing retail
90-day prescriptions. This could lead to increased costs.</span><span style="background: white; font-size: 11pt;"><o:p></o:p></span></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><span style="background: white; font-size: 11pt;"><br /></span></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><span style="background: white; font-size: 11pt;">However, as the entire medical community focuses on the COVID-19
pandemic, volumes of other types of medical visits and prescriptions have
dropped dramatically. According to a survey taken by Piper Sandler, a financial
services company located in Minneapolis, patient volumes are down 65% and may
still be down by about 12% one year from now.</span><span style="background: white; font-size: 11pt;"><o:p></o:p></span></span></div>
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<br /></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><span style="background: white; font-size: 11pt;">In addition, more than half of all office visits will be via telemedicine through the foreseeable future. Telehealth visits are expected to be
as high as 54% of all visits, which is more than a 5-fold increase over
pre-COVID-19 numbers. This will help some practices, but is still contributing
to a furlough of some medical staffing.</span><span style="background: white; font-size: 11pt;"><o:p></o:p></span></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><span style="background: white; font-size: 11pt;"><br /></span></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><span style="background: white; font-size: 11pt;">Along
with an unprecedented drop in patient volumes, prescription writing dropped by
47% in March, as patients refrain from normal office visits. It is expected to
be down by a similar percentage in April. The number of prescriptions for some
drugs have declined significantly, while others appear to be holding steady. Total
prescriptions for drugs for acute use, such as headaches or heartburn, have
plummeted by 28% since February. In contrast, chronic disease therapies, such
as those for diabetes or mental health, are doing well, with weekly scripts
even growing 2% at the end of March as compared with early February.</span><span style="background: white; font-size: 11pt;"><o:p></o:p></span></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><span style="background: white; font-size: 11pt;"><br /></span></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><span style="background: white; font-size: 11pt;">Vaccines
saw the most decline, most likely because people are concerned about going to
doctor offices and pharmacies for vaccinations to address viruses and diseases
they do not even have. Other medications that have declined are ophthalmic
preparations such as Restasis, and IBS-Constipation medications such as
Linzess. Meanwhile, the autoimmune market, HIV and anticoagulants have so far not
seen any changes.</span><span style="background: white; font-size: 11pt;"><o:p></o:p></span></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><span style="background: white; font-size: 11pt;"><br /></span></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><span style="background: white; font-size: 11pt;">Biopharma is not immune to this phenomenon. The current lockdown is not only hurting clinical trial enrollment, but also delaying regulatory timelines for those drugs that are nearing an approval. New drug marketing has also been affected because pharmaceutical representatives are unable to call on doctors due to COVID-19 social distancing and quarantine guidelines; for example, the launch of Bristol Myers Squibb's long-awaited Multiple Sclerosis drug, Zeposia, has been postponed.</span></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><span style="background: white; font-size: 11pt;"><br /></span></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><span style="background: white; font-size: 11pt;">The coronavirus impact as it relates to the pharmacy benefit is changing by the hour. The PBIRx team of clinical pharmacists is constantly researching to keep our clients and partners abreast of the newest information so that they can make knowledgeable decisions.</span></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><a href="https://www.healthcaredive.com/news/doctors-say-covid-19-has-slashed-patient-volumes-made-finances-shaky/575876/">https://www.healthcaredive.com/news/doctors-say-covid-19-has-slashed-patient-volumes-made-finances-shaky/575876/</a><o:p></o:p></span></div>
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><a href="https://www.fiercepharma.com/marketing/retail-scripts-vaccines-and-acute-drugs-decline-sharply-amid-covid-19">https://www.fiercepharma.com/marketing/retail-scripts-vaccines-and-acute-drugs-decline-sharply-amid-covid-19</a><o:p></o:p></span></div>
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<a href="https://www.fiercepharma.com/marketing/biopharma-s-drug-launch-trajectory-bent-by-covid-19-but-some-maybe-more-resilient"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">https://www.fiercepharma.com/marketing/biopharma-s-drug-launch-trajectory-bent-by-covid-19-but-some-maybe-more-resilient</span></a><span style="background: white; font-family: "Arial",sans-serif; font-size: 11.0pt;"><o:p></o:p></span></div>
<br />PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com2tag:blogger.com,1999:blog-1653002039921749625.post-46501854565153083442020-04-17T16:46:00.000-04:002020-04-17T16:46:30.551-04:00COVID-19 Vaccine<br />
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<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;">Recent statistics in the United States reveal nearly 700,000
confirmed coronavirus cases and over 36,000 casualties. Mitigation strategies
and an improved awareness of the highly transmissible nature of COVID-19 have
over 95% of Americans on orders to stay at home. While therapeutic options to
treat infected people continue to be investigated, it is apparent that an
effective vaccine is needed to prevent people from contracting the deadly virus
and enable the world to return to a sense of normalcy. <o:p></o:p></span></div>
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<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;">Prior estimates from Dr. Fauci, t<span style="background: white; color: #222222;">he director of the National Institute of Allergy and
Infectious Diseases, </span>for the development and approval of a potential
vaccine were 12 to 18 months, which would be much faster than the typical time
required for vaccine development. Data has shown that the rate at which
SARS-CoV-2, the virus that causes COVID-19, mutates is not as rapid as the
seasonal influenza virus. This is encouraging because if a vaccine becomes
readily available within the next couple of years, it could have a prolonged
effect by eliminating future cases. There are currently over 70 vaccines in
various stages of development globally. <o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;">The Coalition for Epidemic Preparedness Innovations (CEPI)
and the Biomedical Advanced Research and Development Authority (BARDA) have
contributed hundreds of millions of dollars to develop and facilitate the
costly process of finding a safe and effective vaccine. In addition, thirteen
drug companies have agreed to collaborate and share their proprietary molecular
compounds with a COVID-19 therapeutic accelerator launched by the Bill and
Melinda Gates Foundation in an effort to expedite the development, manufacture
and delivery of vaccines, diagnostics and treatments for COVID-19. Most
notably, Novartis, Boehringer Ingelheim, Eli Lilly, Gilead, GlaxoSmithKline, Johnson
& Johnson, Merck, and Pfizer are engaged in the race to develop the vital
vaccine. GSK and Sanofi have joined forces in an unprecedented collaborative
effort with the hopes that combining their resources and technology will have a
synergistic effect. <o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;">Among the vaccine technologies under consideration are
whole virus vaccines, recombinant protein subunit vaccines, and nucleic acid
vaccines. Any drug or vaccine must go through three phases of clinical trials
before FDA approval. There are two vaccines currently in Phase 1 of clinical
trials in the United States, with many more being evaluated around the world. The
purpose of Phase 1 trials is to determine the safety profile in healthy adults.
<o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;">Moderna Therapeutics rapidly developed an early prospect
for clinical trials on March 16<sup>th</sup>, just 42 days after the genetic
sequence for SARS-CoV-2 was released. Their candidate, known as mRNA-1273 is a
novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for
a stabilized spike (S) protein of SARS-CoV-2. In their Seattle based trial, forty-five
healthy adults will be enrolled into one of three cohorts and will receive two
intramuscular injections four weeks apart to assess the safety and
reactogenicity of mRNA-1273, with subsequent evaluation at regular intervals
over the course of 12 months. It is important to note that the biotechnology
being utilized has been in existence for nearly 30 years, yet has never
produced a viable, FDA-approved vaccine for any human disease. This highlights
the fact that laboratory and animal studies cannot be extrapolated to determine
appropriate use in humans. <o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;">Inovio Pharmaceuticals announced on April 6<sup>th</sup>
that the FDA accepted its application for INO-4800, its DNA vaccine candidate.
DNA medicines are made of optimized DNA plasmids which are synthesized or
reorganized by computer sequencing technology with the hopes of targeting a
specific immune response. Preclinical data has shown positive immune response
results across numerous animal models. The Phase 1 study of INO-4800 will
enroll up to 40 healthy adults in Philadelphia and Kansas City where they will
also receive two doses four weeks apart. Initial immune responses and safety
data are expected to be available by late summer. Inovio plans to have a
million doses of the vaccine manufactured by the end of the year for additional
trials and emergency use, pending regulatory approval and funding. <o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;">Novavax announced on April 8<sup>th</sup> that it has
identified an “ideal” COVID-19 vaccine candidate and is set to begin their
first clinical human trial in May. The candidate, known as NVX-CoV2373, has
demonstrated an ability to produce immune responses and high levels of
antibodies against COVID-19 in animal studies. NVX-CoV2373 uses antigens
derived from the coronavirus spike protein to stimulate an immune response to
provide protection against COVID-19. Novavax is working with another firm,
Emergent BioSolutions, to expedite the process and they expect to have
preliminary human data by July. <o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;">While vaccines undergo the beginning stages of development,
treatment options continue to evolve with data from around the world. Researchers
in the New England Journal of Medicine concluded that treatment with Remdesivir
in a clinical trial of 53 people resulted in clinical improvement in 68% of
patients. Rates of mortality, hospital discharges, and the ability to
discontinue ventilator use were the factors considered in determining clinical
improvement. No new safety concerns were observed, which is encouraging for an
uninhibited approval process. <o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;">Hydroxychloroquine continues to be a top therapeutic
candidate for the treatment of COVID-19 with clinical trials underway in
nations worldwide. However, a trial studying use of high-dose and low-dose
chloroquine in hospitalized patients in Brazil resulted in premature
termination of the high-dose arm due to safety concerns after only 81 patients
were treated. One of the most concerning adverse effects of chloroquine is QT
prolongation and arrythmia, which is an irregular heart rate and may be fatal. <span style="mso-spacerun: yes;"> </span>Azithromycin, an antibiotic often used in
conjunction with hydroxychloroquine to treat COVID-19, is also known to produce
QT prolongation in patients with certain cardiovascular disorders. For that
reason, the American College of Cardiology, American Heart Association, and
Heart Rhythm Society issued a joint statement outlining critical cardiovascular
considerations for use of <span style="background: white; color: #444444;">hydroxychloroquine
and azithromycin for treatment of COVID-19.<span style="background: yellow; mso-highlight: yellow;"><o:p></o:p></span></span></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><span style="background: white; color: #444444;"><br /></span></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="color: black; font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%; mso-themecolor: text1;">Further studies and
anecdotal reports of hydroxychloroquine treatment of COVID continue to be
presented in the news. Reports include individuals such as a lawmaker, a New
Jersey healthcare provider, and a former NFL player who believe that
hydroxychloroquine helped them defeat the virus. Overall, these reports have
been both positive and negative. A small study in France in eleven<span style="mso-spacerun: yes;"> </span>consecutive patients failed to show an
improvement of symptoms <span style="mso-spacerun: yes;"> </span>and reduction in
viral load after being treated with </span><span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/hydroxychloroquine" title="Learn more about Hydroxychloroquine from ScienceDirect's AI-generated Topic Pages"><span style="color: black; mso-themecolor: text1; text-decoration: none; text-underline: none;">hydroxychloroquine</span></a><span style="color: black; mso-themecolor: text1;"> (600</span> mg per day for 10 days) and <a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/azithromycin" title="Learn more about Azithromycin from ScienceDirect's AI-generated Topic Pages"><span style="color: black; mso-themecolor: text1; text-decoration: none; text-underline: none;">azithromycin</span></a> (500 mg day 1 and 250 mg days 2 to
5) and discusses a patient who experienced QT interval prolongation before
treatment was discontinued. Another newly publicized study in Shanghai in 150
patients reported hydroxychloroquine failed to clear the virus better than
standard care but patients receiving it did show improvement in clinical
symptoms and a reduction of an important inflammatory marker in the blood. Side
effects observed in this study were mostly mild and reported in half of the patients
that received treatment. This prompted the study investigators to suggest that
hydroxychloroquine’s potential effects against COVID-19 may be its
anti-inflammatory mechanisms.<o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><span style="mso-spacerun: yes;"> </span>A large scale study,
titled “the Outcomes Related to COVID-19 treated with Hydroxychloroquine among
In-patients with symptomatic Disease study” (ORCHID Study), in Tennessee has
begun to evaluate the effects of the drug in a blinded, placebo-controlled
randomized clinical trial of over 500 adults. The study is enrolling patients
currently hospitalized with COVID-19 or in an emergency department with
anticipated hospitalization. The National Institutes of Health (NIH) is
overseeing this study, as well as one to evaluate Remdesivir in a similar
manner. This is a significant development because prior studies were not
conducted in a blinded, placebo-controlled randomized nature. These factors are
indicative of a more valid scientific approach and are more likely to have an
impact on FDA approval than small anecdotal type reports that were previously
reported.<o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;">Convalescent plasma and hyperimmune globulin from
individuals who have fought off the virus and have developed antibodies remain
a viable treatment option. The blood obtained from these people may be
administered to critically ill patients diagnosed with COVID-19. The FDA is
leading a collaborative effort with partners from the pharmaceutical industry,
academic institutions, and government partners to implement a protocol that
would involve the MAYO clinic and the American Red Cross to collect and
distribute plasma to patients around the country. <o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;">As the number of confirmed cases and deaths attributable to
COVID-19 continue to mount, researchers continue to work diligently to evaluate
which treatment options prove to be the most safe and effective. Vaccines
remain the only way to eradicate such a disease and from having catastrophic
effects in the future. <o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><br /></span></div>
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<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><a href="https://www.nationalgeographic.com/science/2020/04/why-coronavirus-vaccine-could-take-way-longer-than-a-year/">https://www.nationalgeographic.com/science/2020/04/why-coronavirus-vaccine-could-take-way-longer-than-a-year/</a><o:p></o:p></span></div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><a href="https://www.nejm.org/doi/full/10.1056/NEJMp2005630">https://www.nejm.org/doi/full/10.1056/NEJMp2005630</a><o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><a href="https://clinicaltrials.gov/ct2/results?cond=COVID-19&term=vaccine&cntry=&state=&city=&dist=&Search=Search">https://clinicaltrials.gov/ct2/results?cond=COVID-</a></span><a href="https://clinicaltrials.gov/ct2/results?cond=COVID-19&term=vaccine&cntry=&state=&city=&dist=&Search=Search" style="font-family: Arial, sans-serif; font-size: 10pt;">19&term=vaccine&cntry=&state=&city=&dist=&Search=Search</a></div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><a href="https://bgr.com/2020/04/07/coronavirus-vaccine-update-who-wants-cures-to-be-widely-available/">https://bgr.com/2020/04/07/coronavirus-vaccine-update-who-wants-cures-to-be-widely-available/</a><o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><a href="https://nypost.com/2020/04/08/novavax-to-start-trial-for-ideal-coronavirus-vaccine-candidate/">https://nypost.com/2020/04/08/novavax-to-start-trial-for-ideal-coronavirus-vaccine-candidate/</a><span style="mso-tab-count: 1;"> </span></span></div>
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<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><span style="mso-tab-count: 1;"> </span><o:p></o:p></span></div>
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<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-blood-purification-device-treat-covid-19">https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-blood-purification-device-treat-covid-19</a><o:p></o:p></span></div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><a href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-coordinates-national-effort-develop-blood-related-therapies-covid-19">https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-coordinates-national-effort-develop-blood-related-therapies-covid-19</a><o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><a href="https://www.beckershospitalreview.com/pharmacy/gilead-boosts-remdesivir-production-now-has-1-5m-doses.html">https://www.beckershospitalreview.com/pharmacy/gilead-boosts-remdesivir-production-now-has-1-5m-doses.html</a><o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><a href="https://www.beckershospitalreview.com/pharmacy/13-drugmakers-form-consortium-to-find-covid-19-treatments.html">https://www.beckershospitalreview.com/pharmacy/13-drugmakers-form-consortium-to-find-covid-19-treatments.html</a><o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><a href="https://www.who.int/blueprint/priority-diseases/key-action/novel-coronavirus-landscape-ncov.pdf?ua=1">https://www.who.int/blueprint/priority-diseases/key-action/novel-coronavirus-landscape-ncov.pdf?ua=1</a>
<o:p></o:p></span></div>
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<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"> <o:p></o:p></span></div>
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<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><a href="https://endpts.com/a-quick-slice-of-the-data-from-a-small-remdesivir-study-suggests-it-may-be-working-against-covid-19-but-all-the-big-questions-remain-to-be-answered/">https://endpts.com/a-quick-slice-of-the-data-from-a-small-remdesivir-study-suggests-it-may-be-working-against-covid-19-but-all-the-big-questions-remain-to-be-answered/</a><o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><a href="https://www.the-scientist.com/news-opinion/covid-19-vaccine-frontrunners-67382">https://www.the-scientist.com/news-opinion/covid-19-vaccine-frontrunners-67382</a><o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><a href="https://www.nih.gov/news-events/news-releases/nih-clinical-trial-hydroxychloroquine-potential-therapy-covid-19-begins">https://www.nih.gov/news-events/news-releases/nih-clinical-trial-hydroxychloroquine-potential-therapy-covid-19-begins</a><o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><a href="https://cepi.net/covid-19/">https://cepi.net/covid-19/</a><o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><a href="https://www.nytimes.com/2020/04/12/health/chloroquine-coronavirus-trump.html?auth=login-email&login=email">https://www.nytimes.com/2020/04/12/health/chloroquine-coronavirus-trump.html?auth=login-email&login=email</a><span class="MsoHyperlink"><o:p></o:p></span></span></div>
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<span style="font-family: "Arial",sans-serif; font-size: 10.0pt; line-height: 107%;"><a href="https://www.acc.org/latest-in-cardiology/articles/2020/04/10/15/06/acc-joins-aha-hrs-in-statement-on-exploratory-covid-19-treatment-drug-interactions-on-qtc">https://www.acc.org/latest-in-cardiology/articles/2020/04/10/15/06/acc-joins-aha-hrs-in-statement-on-exploratory-covid-19-treatment-drug-interactions-on-qtc</a>
<o:p></o:p></span></div>
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<br />PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com1tag:blogger.com,1999:blog-1653002039921749625.post-85241824573923650932020-03-30T16:01:00.002-04:002020-03-30T16:01:16.740-04:00COVID-19 Treatment Options Update<br />
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">The United States has surpassed China and Italy with the
highest number of novel coronavirus (COVID-19) cases. As of March 30th, the US
has an estimated 149,000 confirmed cases and 2,600 deaths spanning all 50
states and the District of Columbia. The rapid surge in positive cases is a
testament to how contagious the virus is and the nationwide expansion of
coronavirus testing. <o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">Medical experts, including Dr. Anthony Fauci, Director of
National Institute of Allergy and Infectious Disease, anticipate the virus
could become a seasonal occurrence and the most effective way to prevent future
pandemics would be a vaccine, like the seasonal flu shot.<span style="mso-spacerun: yes;"> </span>However, coronavirus vaccines will require at
least 12 to 18 months of clinical study before they are approved for use. <o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">Meanwhile, clinical trials are underway worldwide to evaluate
various treatments for coronavirus infected patients to identify those that are
safe and effective. <span style="mso-spacerun: yes;"> </span>Drugs under
consideration include some that are available now because they are FDA approved
to treat other diseases. Therefore, the possibility of repurposing these drugs to
treat COVID-19 has been a primary focus for researchers.</span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
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<b><i><span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">Avigan (favipiravir</span></i></b><span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">) has demonstrated
promise in shortening the duration of fever and cough in patients infected with
COVID-19; also known as SARS-CoV-2. More importantly, as hospital admissions
increase in the US, <b><i>favipiravi</i></b>r has been shown to reduce the need
for a ventilator in a clinical trial of 200 patients in the Chinese cities of
Wuhan and Shenzhen. The shortage of ventilators, required to keep people alive
and breathing in severe respiratory illnesses, is a major concern in the United
States.</span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
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<span style="color: black; font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%; mso-themecolor: text1;">Perhaps the most extensively discussed COVID-19 treatment
candidate is <b><i>hydroxychloroquine</i></b>, which was approved by the FDA
today as an emergency treatment for COVID-19<span style="mso-spacerun: yes;">
</span>along with other FDA approved conditions for this drug, i.e. <span style="mso-spacerun: yes;"> </span>lupus, rheumatoid arthritis, and malaria. By
now most people have heard about the French study of <b><i>hydroxychloroquine</i></b>
in combination with <b><i>azithromycin</i></b>, an antibiotic commonly known as
“Z-PAK”. The results of this study are promising; however, this positive news
has led to unintended consequences. Pharmacists are seeing a massive increase
in <b><i>hydroxychloroquine</i></b> prescriptions as physicians are prescribing
it off-label for themselves and family members.</span></div>
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<span style="color: black; font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%; mso-themecolor: text1;"><br /></span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12pt; line-height: 107%;">In efforts to
contain this potential shortage, pharmacy benefit managers such as Express
Scripts and CVS Health have implemented quantity limits and fill restrictions while
state pharmacy boards have issued emergency restrictions on how the drugs can
be dispensed. </span><span style="font-family: "Proxima Nova"; font-size: 12pt; line-height: 107%;">Walgreens now has a 14-day limit for new
prescriptions and a 30-day supply limit for refills of <b><i>hydroxychloroquine.</i></b></span><span style="font-family: "Proxima Nova"; font-size: 12pt; line-height: 107%;"> </span><span style="font-family: "Proxima Nova"; font-size: 12pt; line-height: 107%;">Furthermore,
medical authorities issued a warning about self-treatment after a tragic case
of poisoning where an Arizona couple </span><span style="font-family: "Proxima Nova"; font-size: 12pt; line-height: 107%;">in
their sixties were hospitalized after ingesting a form of chloroquine sold to clean
fish tanks.</span></div>
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<br />
<br />
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<b><i><span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">Remdesivir</span></i></b><span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">, a drug administered only intravenously,
as opposed to oral drugs <b><i>chloroquine</i></b> and <b><i>Avigan,</i></b> remains
a top candidate to become one of the first antiviral drugs to gain FDA approval
in the United States. <b><i>Remdesivir,</i></b> which was originally being
developed by Gilead to treat Ebola, incorporates itself into viral RNA and
prevents the virus from replicating. It has shown in laboratory studies to be
more effective against coronavirus than <b><i>Avigan</i></b> and chloroquine.
With more clinical data showing safety and efficacy, it is feasible to see it
gain FDA approval. </span><span style="background: white; color: black; font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%; mso-bidi-font-family: Calibri; mso-bidi-theme-font: minor-latin;">A</span><span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">nalysts from Seeking Alpha previously
reported intravenous <b><i>remdesivir</i></b> would only be used for severe
cases of COVID-19 infection. However, after positive reports of the
effectiveness of <b><i>Avigan</i></b>, a related antiviral drug, they now also view
<i>remdesivir</i> as a treatment for more moderate cases. Unfortunately, the
most recent development with <b><i>remdesivir</i></b> is that its manufacturer,
Gilead Sciences, is so backed up with compassionate use requests that it is now
limiting its availability to clinical trial use.</span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">Recent weeks brought two noteworthy updates about the HIV drug <b><i>Kaletra</i></b>
(l<i>opinavir/ritonavir</i>) which has been studied around the world for
COVID-10 treatment. AbbVie, the manufacturer of <b><i>Kaletra </i></b>altruistically
suspended their global patent rights to help the global community with the
supply of this drug. Unfortunately, the other noteworthy update was one of
disappointment. In an article in the New England Journal of Medicine,
researchers reported that <b><i>Kaletra</i></b> failed to show a benefit in
reducing mortality rates and time to clinical improvement in a clinical trial
of 199 people in China. To put this result in context, it is important to note
that patients were very sick and had been symptomatic for two weeks before they
started the treatment. However, the authors express their opinion that <b><i>Kaletra
</i></b>was not particularly potent against COVID-19. <b><i>Kaletra </i></b>has
been noted to be effective in other worldwide reports and continues to be
studied for treatment of COVID-19.<o:p></o:p></span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">Specialty drugs, <b><i>Kevzara </i></b>and <b><i>Actemra</i></b>,
continue to be evaluated in the role they may play in dealing with the
repercussions of lung inflammation caused by the coronavirus. If fewer patients
progress from needing supplemental oxygen therapy to being intubated with a
ventilator, scarce resources may be better used. Researchers are postulating
that the aggressive immune response to COVID-19 that leads to lung inflammation
and pneumonia is caused by what is known as a cytokine storm. Another drug that
has promise in modulating cytokine storm and severe pulmonary complications of
COVID-19 infection is <b><i>leronlimab</i></b>. </span><span style="background: white; color: #2a2a2a; font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%; mso-bidi-font-family: Calibri; mso-bidi-theme-font: minor-latin;">Two critically
ill patients in New York City were taken off ventilators and out of intensive
care after they received <b><i>leronlimab,</i></b> an experimental drug being
developed for HIV and breast cancer.</span></div>
<br />
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">Serology testing, also known as antibody testing, allows
researchers to evaluate how many people have been previously exposed to the
virus and able to fight it off without being symptomatic. When a person is
exposed to a disease-causing agent like SARS-CoV-2, their immune system
produces antibodies to fight off infection. Antibody tests require only a small
blood sample, are relatively inexpensive, and can produce results in about 15
minutes. It is possible antibody testing can be used to determine who can go back
to work and who needs to stay home for a 14-day quarantine before returning to
work.</span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">New York, which has the highest number of confirmed cases and casualties
in the country, is conducting a trial to test how effective convalescent plasma
from people who have recovered from COVID-19 can be as a treatment. This method
has previously been proven to be effective during the Spanish Flu epidemic of
1918, the SARS outbreak of 2003 and the Ebola epidemic of 2013. The infusion of
convalescent plasma introduces antibodies that can illicit an effective immune
response and shorten the duration and severity of infection. <o:p></o:p></span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">As the effects of COVID-19 continue to create more devastation
globally, the race to find a treatment and vaccine are of the utmost
importance. Ongoing clinical trials and increased testing have helped to more
accurately identify the magnitude of the virus’ traumatic effects and possibly
identify safe and effective ways to treat those who are infected. Until then,
precautionary measures remain the best way to avoid contracting the virus.</span></div>
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</span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">With a larger number of infected patients worldwide comes a greater
set of data which scientists are able to leverage to gain a better
understanding of how the virus is spread, the progression of symptoms, and most
importantly which medications may be effective to reduce the severity of
symptoms and shorten the time for an infected person to recover and test
negative for the virus.</span></div>
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<span style="font-family: "Proxima Nova";"><span style="font-size: x-small;"><a href="https://abcnews.go.com/Health/blood-tests-battle-covid-19-us/story?id=69761676"><span style="color: blue;">https://abcnews.go.com/Health/blood-tests-battle-covid-19-us/story?id=69761676</span></a><span style="color: #3d85c6;"><o:p></o:p></span></span></span></div>
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<span style="font-family: "Proxima Nova";"><span style="font-size: x-small;"><a href="https://www.drugtargetreview.com/news/58608/remdesivir-most-promising-covid-19-drug-say-researchers/"><span style="color: blue;">https://www.drugtargetreview.com/news/58608/remdesivir-most-promising-covid-19-drug-say-researchers/</span></a><span style="color: #3d85c6;"><o:p></o:p></span></span></span></div>
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<span style="font-family: "Proxima Nova";"><span style="color: #3d85c6; font-size: x-small;"><a href="https://www.fiercepharma.com/pharma-asia/top-covid-19-aspirants-chloroquine-abbvie-s-kaletra-and-a-flu-drug-disappoint-clinical">https://www.fiercepharma.com/pharma-asia/top-covid-19-aspirants-chloroquine-abbvie-s-kaletra-and-a-flu-drug-disappoint-clinical</a><o:p></o:p></span></span></div>
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<span style="font-family: "Proxima Nova";"><span style="color: #3d85c6; font-size: x-small;"><a href="https://www.ibtimes.com/coronavirus-cure-new-york-treat-covid-19-blood-recovered-patients-2945195">https://www.ibtimes.com/coronavirus-cure-new-york-treat-covid-19-blood-recovered-patients-2945195</a><o:p></o:p></span></span></div>
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<span style="font-family: "Proxima Nova"; line-height: 107%;"><a href="https://medcitynews.com/2020/03/abbvies-hiv-drug-fails-covid-19-trial-in-china-but-a-fujifilm-flu-drug-may-have-efficacy/"><span style="color: blue; font-size: x-small;">https://medcitynews.com/2020/03/abbvies-hiv-drug-fails-covid-19-trial-in-china-but-a-fujifilm-flu-drug-may-have-efficacy/</span></a></span></div>
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<span style="font-family: "Proxima Nova";"><span style="color: #3d85c6; font-size: x-small;"><a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2001282">https://www.nejm.org/doi/full/10.1056/NEJMoa2001282</a><span class="MsoHyperlink"><o:p></o:p></span></span></span></div>
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<span style="font-family: "Proxima Nova";"><span style="color: #3d85c6; font-size: x-small;"><a href="https://nypost.com/2020/03/28/coronavirus-patients-taken-off-ventilators-after-getting-experimental-hiv-drug/?utm_campaign=iosapp&utm_source=mail_app">https://nypost.com/2020/03/28/coronavirus-patients-taken-off-ventilators-after-getting-experimental-hiv-drug/?utm_campaign=iosapp&utm_source=mail_app</a><o:p></o:p></span></span></div>
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<span style="font-family: "Proxima Nova";"><span style="color: #3d85c6; font-size: x-small;"><a href="https://www.statnews.com/2020/03/27/serological-tests-reveal-immune-coronavirus/">https://www.statnews.com/2020/03/27/serological-tests-reveal-immune-coronavirus/</a><o:p></o:p></span></span></div>
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<span style="font-family: "Proxima Nova";"><span style="color: #3d85c6; font-size: x-small;"><a href="https://seekingalpha.com/article/4334200-gileads-remdesivir-can-be-game-changer?li_source=LI&li_medium=liftigniter-widget">https://seekingalpha.com/article/4334200-gileads-remdesivir-can-be-game-changer?li_source=LI&li_medium=liftigniter-widget</a><o:p></o:p></span></span></div>
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<span style="font-family: "Proxima Nova";"><span style="font-size: x-small;"><a href="https://www.pharmacist.com/article/pharmacies-set-policies-stop-us-hoarding-potential-coronavirus-treatments"><span style="color: blue;">https://www.pharmacist.com/article/pharmacies-set-policies-stop-us-hoarding-potential-coronavirus-treatments</span></a><o:p></o:p></span></span></div>
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PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com3tag:blogger.com,1999:blog-1653002039921749625.post-40635437813813161192020-03-25T10:16:00.000-04:002020-03-25T10:16:58.890-04:00<br />
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<b><span style="font-family: "Proxima Nova";">COVID-19 (CORONAVIRUS) TREATMENTS UNDER
CONSIDERATION<o:p></o:p></span></b></div>
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<br /></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">At PBIRx, our
highly experienced and educated Clinical Staff, including licensed registered pharmacists
and PharmDs, have done careful research to share the following treatments that
are being considered for use in the United States and/or being evaluated globally
in clinical trials. It is important to note that as data continues to be
collected, new treatment options will emerge. <o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">COVID-19
(coronavirus) is a <b><u>new</u></b> global virus with currently no FDA
approval of medications to treat infected patients or vaccines to prevent its
rapid spread. However, since the virus began to infect and kill people in China
in December 2019, medical professionals, including pharmaceutical manufacturers
around the world, have been working to create a vaccine, while also evaluating many
different drugs and combinations of drugs to treat and prevent COVID-19. <span style="mso-spacerun: yes;"> </span><o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">It is important
to note that all drugs have possible adverse effects and the research focuses
on the possible risk of side effects versus potential efficacy in human
patients. Agents being used at this time are being administered in an
experimental setting under controlled conditions. No one is administered a drug
for COVID-19 without a doctor’s authorization. Data on drug effectiveness and
safety are collected by enrolling infected patients into clinical trials or through
compassionate use as they are treated.
Some of the drugs being used for COVID treatment are approved for other uses in
the United States while others have only been used in other countries until now.
<o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">Treatment options
often depend on many factors including age of patient, comorbidities, side
effect risks, severity of coronavirus symptoms, patient specific allergies, and
availability/accessibility, etc.<o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">The first drug
approved in China, or anywhere, to treat COVID-19 is <b><i>Favilavir, </i></b><i>known
generically as<b> favipiravir</b></i> or under the brand name <b><i>Avigan</i></b>
in Japan<b><i>.<span style="mso-spacerun: yes;"> </span>Avigan</i></b> is an
anti-viral drug that is active against RNA viruses and marketed in Japan for
treatment of influenza.</span></div>
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<b><span style="mso-spacerun: yes;"><span style="font-family: Arial, Helvetica, sans-serif;"><br /></span></span></b></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">According
to China National Center for Biotechnology, <b><i>Favilavir </i></b>demonstrated
an encouraging profile with mild adverse reactions in seventy (70) COVID-19 patients
in a clinical trial in Shenzhen
and Guangdong Provinces. The<b><i> </i></b>National
Medical Products Administration of China has therefore approved the use of <b><i>Favilavir</i></b>,
based on such clinical trials. Researchers noted that the drug has reportedly
shown efficacy in hindering the spread and treating the disease with minimal
side effects. <o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: Arial, Helvetica, sans-serif;"><b><i>Favipiravir</i></b> has also shown effectiveness in other reports of its treatment of
COVID-19 in China<b>.<i> </i></b>Chinese medical authorities reported positive
responses in <b><i>favipiravir</i></b> clinical trials conducted in Wuhan and
Shenzhen composed of 340 people. About 91% of infected patients treated with <b><i>favipiravir</i></b>
showed improved lung function compared to 62% who did not receive any treatment
and did not show improvement.<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>More significantly, those treated with <b><i>favipiravir</i></b>
had a median of four (4) days to test negative, compared to eleven (11) days
among those that did not receive treatment. <span style="mso-spacerun: yes;"> </span>Some health officials noted that the results
have not been as promising in people with a higher viral load and more severe
symptoms. <b><i>Favipiravir </i></b>is also being developed in Japan for West
Nile virus, yellow fever, and rabies.<o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">Other drugs
showing efficacy, which also do not have FDA approval in the US for COVID -19
treatment are the anti-malaria drugs <b><i>hydroxychloroquine</i></b> and <b><i>chloroquine</i></b>
as well as Gilead’s experimental broad-spectrum antiviral drug <b><i>remdesivir</i></b>.<o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: Arial, Helvetica, sans-serif;"><b><i>Hydroxychloroquine/chloroquine</i></b><b> (brand name <i>Plaquenil/Aralen, Resochin</i>)</b> are currently used in the United States and around the world to
treat a variety of conditions that include malaria, lupus, and rheumatoid
arthritis. Now they are being evaluated to determine if their use in COVID-19
infected patients leads to improved virological clearance and reduced mortality.
President Trump announced on March 19<sup>th</sup> that the FDA has approved testing
of <b><i>hydroxychloroquine</i> </b>and<b> <i>chloroquine</i> </b>for the
treatment of COVID-19 through clinical trials and “<i>compassionate use”</i>. Below
are links to publications describing 100 patients effectively treated with <b><i>chloroquine</i></b>
in Wuhan, ten (10) hospitals throughout China effectively treating patients with
<b>hydroxychloroquine</b>, and twenty four (24) patients in France effectively treated
with <b><i>chloroquine</i></b>. The results in France are not officially published
yet.<span style="mso-spacerun: yes;"> </span><o:p></o:p></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;"><span style="mso-spacerun: yes;"><br /></span></span></div>
<div style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">The most recently
talked about and seemingly most positive of all is a new study published in the
<em>International Journal of Antimicrobial Agents.
</em>The study was conducted after reports from the treatment of Chinese
patients indicated that a combination of <b><i>hydroxychloroquine</i></b> with
a popular antibiotic shortened the duration of COVID-19infection. <em>The new study</em> found early evidence that the
combination of <b><i>hydroxychloroquine</i></b> and the antibiotic <b><i>azithromycin
</i></b>(<b><i>Zithromax, Z-pack</i></b>) could be especially effective in
treating the virus and reducing its duration in patients. The researchers
performed this study in thirty (30) confirmed COVID-19 patients comparing <b><i>hydroxychloroquine
</i></b>on its own or in combination with <b><i>azithromycin</i></b> to control
patients (received neither treatment). <b><i>Hydroxychloroquine</i></b> was
effective on its own and even more effective, by a significant margin, when
combined with <b><i>azithromycin</i></b>. <o:p></o:p></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;"><br /></span></div>
<div style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;"><b><i>Hydroxychloroquine</i></b> eliminated the COVID virus in over fifty (50)
percent of patients in 6 days while the combination eliminated the virus all
patients in five (5) days. At
enrollment, six (6) patients in the study presented with no symptoms (n=6),
twenty two (22) patients presented with upper
respiratory tract symptoms (sneezing, headaches and sore throats, n=22), and eight
(8) patients presented with lower respiratory tract symptoms (mostly coughing,
n=8).<span style="font-size: 11pt;"><o:p></o:p></span></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;"><b><i>Remdesivir </i></b>a broad-spectrum nucleoside
inhibitor antiviral, also known as GS-5734, has received a lot of attention in
the media. <b><i>Remdesivir</i></b> is under investigation by Gilead Sciences
for treatment of Ebola virus (a filovirus) and has shown activity against other
respiratory RNA viruses like SARS-CoV and MERS-CoV. The World Health
Organization (WHO) has noted <b><i>Remdesivir</i></b> efficacy in treating the
coronavirus in China. There are now several studies ongoing to establish its
safety, effectiveness and dosing <i>against COVID-19</i>. <span style="mso-spacerun: yes;"> </span>Four (4) of these studies are located within the
United States. Of note, currently there are concerns with its safety. GI issues
and elevated liver enzymes are most notable, although this is not uncommon with
other anti-viral medications. <o:p></o:p></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;"><b><i>Kaletra
</i></b>(<b><i>lopinavir and ritonavir</i></b>),
a drug used to treat HIV in the United States, is being evaluated beyond its
current FDA indication, for use in COVID-19. There have been reports in both
China and the US of its effectiveness in treating some COVID-19 patients. It
was effective in combination with <b><i>chloroquine</i></b> in an HCP in New
Jersey who said he “would be dead and gone” if not for this treatment.<b><i> Kaletra,
</i></b>an antiretroviral agent has formerly been shown to be effective against
severe acute respiratory syndrome (SARS) in-vitro. In clinical trials, the
medication is being studied alone and in combination with other anti-viral drug
<b><i>ribavirin</i></b> and with <b><i>interferon</i></b>. <o:p></o:p></span></div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">Below are links
to guidelines from China for COVID-19 treatments, including dosing used for <b><i>lopinavir/ritonavir</i></b>
and other antivirals such as <b><i>ribavirin</i></b>. <o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">Additionally, <b><i>corticosteroids</i></b>
are being investigated in multiple trials for the novel virus. Steroids have
been and continue to be used in the treatment of other severe coronavirus
infections including SARS and MERS to manage symptoms. Several alarming concerns
have arisen from those uses and interim guidance from the WHO recommends
against using corticosteroids in patients with COVID-19 unless they have
another indication.<o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">A potential
vaccine made by Moderna in collaboration with the National Institute of Allergy
and Infectious Diseases is currently being evaluated and tested in the Seattle
area. Their aim is to illicit the immune system to develop antibodies against a
“spike protein” found on the virus. <o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">Johnson &
Johnson, Eli Lilly and Pfizer are also actively working to develop a vaccine. <o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">The University of
Minnesota is evaluating the hypertension drug <b><i>losartan</i> </b>to see how
effective it can be to reduce the risk of organ failure for hospitalized
COVID-19 patients, and if it can reduce the need for hospitalization.<o:p></o:p></span></div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">Specialty drugs
like<b> <i>Kevzara</i> </b>and <b>A<i>ctemra</i> </b>are also being tried in
new ways to treat the lung inflammation caused by COVID-19. <o:p></o:p></span></div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">The WHO
identifies <b><i>baloxavir </i></b><i>(</i>brand name<b><i> Xofluza</i></b><i>)<b>,</b></i>
a newer medication approved for influenza in the US, also as a possible COVID
treatment candidate; however, there have been supply issues since the beginning
of the flu season. It is important to note that the WHO is the only institution
identifying <b><i>Xofluza</i></b> as a potential therapeutic candidate at this
time. More well known in the United States is <b><i>Tamiflu</i></b> (<b><i>oseltamivir</i></b>) which has been recommended by WHO for
influenza pandemics. <b><i>Tamiflu</i></b> is part of a <span class="MsoHyperlink"><span style="color: black; mso-themecolor: text1; text-decoration: none; text-underline: none;"><a href="https://www.cnn.com/2020/03/19/politics/fact-check-chloroquine-trump-fda/index.html"><span style="color: black; mso-themecolor: text1; text-decoration: none; text-underline: none;">clinical trial</span></a></span></span><span style="color: black; mso-themecolor: text1;"> </span>being held in Thailand that will combine it with <b><i>protease
inhibitors</i></b>, <b><i>favipiravir</i></b>, and <b>chloroquine</b> for
treatment of COVID-19.<o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: Arial, Helvetica, sans-serif;">Lastly, many reports
advising against the use of the anti-inflammatory drug <b><i>ibuprofen</i></b>
(brand name <b><i>Motrin</i></b>/<b><i>Advil</i></b>) have come out since
Olivier Veran, the French health minister, tweeted last weekend about some
patients in France experiencing serious side effects. However, the European
Medicines Agency issued a statement on March 18<sup>th</sup> that there is
“currently no scientific evidence establishing a link between <b><i>ibuprofen</i></b>
and worsening of COVID-19.” The World Health Organization tweeted: “Based on
currently available information, WHO does not recommend against the use of <b><i>ibuprofen</i></b>.
We are also consulting with physicians treating COVID-19 patients and are not
aware of reports of any negative effects of ibuprofen, beyond the usual known
side effects that limit its use in certain populations.”<o:p></o:p></span></div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;">In summary, at
this time it remains to be determined how to most effectively treat (and
hopefully soon prevent) COVID-19. The global medical community continues to
work diligently to minimize the effects of COVID-19 and as new data becomes
available, treatment options will inevitably continue to be updated in this
rapidly evolving fluid pandemic. It is vital to keep in mind to follow the
guidelines of official legitimate sources like your medical professional, the
CDC and the WHO to minimize the risk and spread of this virus. </span><span style="font-family: Proxima Nova;"><o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: Arial, Helvetica, sans-serif;"><span class="MsoHyperlink"><a href="https://www.clinicaltrialsarena.com/analysis/coronavirus-mers-cov-drugs/">https://www.clinicaltrialsarena.com/analysis/coronavirus-mers-cov-drugs/</a></span><o:p></o:p></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;"><span class="MsoHyperlink"><a href="https://www.connexionfrance.com/French-news/French-researcher-in-Marseille-posts-successful-Covid-19-coronavirus-drug-trial-results">https://www.connexionfrance.com/French-news/French-researcher-in-Marseille-posts-successful-Covid-19-coronavirus-drug-trial-results</a></span><o:p></o:p></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;"><span class="MsoHyperlink"><a href="https://www.forbes.com/sites/alexknapp/2020/03/13/coronavirus-drug-update-the-latest-info-on-pharmaceutical-treatments-and-vaccines/#53ab4fac21db">https://www.forbes.com/sites/alexknapp/2020/03/13/coronavirus-drug-update-the-latest-info-on-pharmaceutical-treatments-and-vaccines/#53ab4fac21db</a></span><o:p></o:p></span></div>
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<span style="font-family: Arial, Helvetica, sans-serif;"><span class="MsoHyperlink"><a href="https://www.jbc.org/content/early/2020/02/24/jbc.AC120.013056.full.pdf">https://www.jbc.org/content/early/2020/02/24/jbc.AC120.013056.full.pdf</a></span><o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;"><span class="MsoHyperlink"><a href="https://www.jstage.jst.go.jp/article/bst/14/1/14_2020.01047/_pdf/-char/en">https://www.jstage.jst.go.jp/article/bst/14/1/14_2020.01047/_pdf/-char/en</a></span><o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;"><span class="MsoHyperlink"><a href="https://www.jstage.jst.go.jp/article/ddt/14/1/14_2020.01012/_pdf/-char/en">https://www.jstage.jst.go.jp/article/ddt/14/1/14_2020.01012/_pdf/-char/en</a></span><o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;"><span class="MsoHyperlink"><a href="https://news.worldusheadlines.com/2020/03/19/two-generic-drugs-being/">https://news.worldusheadlines.com/2020/03/19/two-generic-drugs-being/</a></span><b><o:p></o:p></b></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span class="MsoHyperlink"><span style="font-family: Arial, Helvetica, sans-serif;"><a href="https://www.npr.org/sections/health-shots/2020/03/18/818026613/advice-from-france-to-avoid-ibuprofen-for-covid-19-leaves-experts-baffled">https://www.npr.org/sections/health-shots/2020/03/18/818026613/advice-from-france-to-avoid-ibuprofen-for-covid-19-leaves-experts-baffled</a><o:p></o:p></span></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span class="MsoHyperlink"><span style="font-family: Arial, Helvetica, sans-serif;"><a href="https://nypost.com/2020/03/18/japanese-flu-drug-clearly-effective-in-treating-coronavirus-officials-say/?utm_campaign=iosapp&utm_source=mail_app">https://nypost.com/2020/03/18/japanese-flu-drug-clearly-effective-in-treating-coronavirus-officials-say/?utm_campaign=iosapp&utm_source=mail_app</a><o:p></o:p></span></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;"><span class="MsoHyperlink"><a href="https://www.pharmacytimes.com/news/potential-pipeline-medications-for-the-coronavirus">https://www.pharmacytimes.com/news/potential-pipeline-medications-for-the-coronavirus</a></span><o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;"><span class="MsoHyperlink"><a href="https://www.theguardian.com/world/2020/mar/18/japanese-flu-drug-clearly-effective-in-treating-coronavirus-says-china">https://www.theguardian.com/world/2020/mar/18/japanese-flu-drug-clearly-effective-in-treating-coronavirus-says-china</a></span><o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span class="MsoHyperlink"><span style="font-family: Arial, Helvetica, sans-serif;"><a href="https://www.who.int/blueprint/priority-diseases/key-action/novel-coronavirus/en/">https://www.who.int/blueprint/priority-diseases/key-action/novel-coronavirus/en/</a><o:p></o:p></span></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;"><span class="MsoHyperlink"><a href="https://techcrunch.com/2020/03/19/french-study-finds-anti-malarial-and-antibiotic-combo-could-reduce-covid-19-duration/">https://techcrunch.com/2020/03/19/french-study-finds-anti-malarial-and-antibiotic-combo-could-reduce-covid-19-duration/</a></span><o:p></o:p></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="font-family: Arial, Helvetica, sans-serif;"><span class="MsoHyperlink"><a href="https://nypost.com/2020/03/12/hiv-drugs-are-being-used-as-part-of-coronavirus-treatment/">https://nypost.com/2020/03/12/hiv-drugs-are-being-used-as-part-of-coronavirus-treatment/</a></span><o:p></o:p></span></div>
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<br /></div>
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<br /></div>
<br /><br />
PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com1tag:blogger.com,1999:blog-1653002039921749625.post-40235841736398210162020-02-06T09:34:00.000-05:002020-02-06T09:34:31.491-05:00Chaos at Chain Pharmacies<br />
<div class="MsoNormal" style="text-align: justify;">
<span style="background: white; font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">It’s every pharmacist’s worst
nightmare…making a serious prescription error while they are rushing to fill
prescriptions for waiting customers. Yet this nightmare becomes a reality all
too often, even more so now than in the past, as the computer age has everyone
accustomed to instant customer service. Many pharmacists believe that even one
Rx error is too many.<o:p></o:p></span></span></div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="background: white; font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Last Saturday the New York
Times published a front page story titled:<o:p></o:p></span></span></div>
<div class="MsoNormal" style="text-align: justify;">
<br /></div>
<div align="center" class="MsoNormal" style="text-align: center;">
<i style="mso-bidi-font-style: normal;"><span style="background: white; font-size: 14pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">“How Chaos at Chain Pharmacies Is Putting Patients at Risk”<o:p></o:p></span></span></i></div>
<div align="center" class="MsoNormal" style="text-align: center;">
<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="background: white; font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">In letters to state regulatory
boards and in interviews with The New York Times, many pharmacists working at
chain pharmacies like CVS, Rite Aid and Walgreens described understaffed and
chaotic workplaces where they said it had become difficult to perform their
jobs safely, putting the public at risk of medication errors. They struggle to
do all of the following things, while racing to meet corporate performance
metrics that they characterized as unreasonable and unsafe in an industry
squeezed to do more with less:<o:p></o:p></span></span></div>
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</div>
<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjG7Yl8wuN-VhP_AjPXulepLf6SR-XxKHN4RQoC_co0rkJQyrSOWmr7m8utVOEK2LzbBgwJRra6PVD9j7ukvcmiLlcOl7-1toIv6oFupu6IgzmeiyJVKjsHnIpxG2uQEFK4wC5eZe77JtcI/s1600/bottle+%2526+pills.jpg" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><img border="0" data-original-height="343" data-original-width="514" height="212" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjG7Yl8wuN-VhP_AjPXulepLf6SR-XxKHN4RQoC_co0rkJQyrSOWmr7m8utVOEK2LzbBgwJRra6PVD9j7ukvcmiLlcOl7-1toIv6oFupu6IgzmeiyJVKjsHnIpxG2uQEFK4wC5eZe77JtcI/s320/bottle+%2526+pills.jpg" width="320" /></span></a></div>
<ul>
<li><span style="background: white; font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Fill prescriptions</span></span></li>
<li><span style="background: white; font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Administer vaccinations</span></span></li>
<li><span style="background: white; font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Tend the drive-through</span></span></li>
<li><span style="background: white; font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Answer phones</span></span></li>
<li><span style="background: white; font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Work the cash register</span></span></li>
<li><span style="background: white; font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Counsel patients</span></span></li>
<li><span style="background: white; font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Call prescribers' offices</span></span></li>
<li><span style="background: white; font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Call insurance companies</span></span></li>
<li><span style="background: white; font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Handle inventory</span></span></li>
</ul>
<br />
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<span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="background: white; font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Michael Jackson, chief
executive of the Florida Pharmacy Association, said the number of complaints
from members related to staffing cuts and worries about patient safety had become
“overwhelming” in the past year. Regulating the chains can be difficult; Florida’s
nine-member state pharmacy board includes a lawyer for CVS and a director of
pharmacy affairs at Walgreens. Pharmacists are often afraid to speak up,
fearing retaliation. The chains deny that their pharmacists are under extreme
pressure, yet their bonuses are often tied to the number of prescriptions they
fill and call lists completed. <o:p></o:p></span></span></div>
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<br /></div>
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<span style="background: white; font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">CVS accounts for one-fourth of
the United States’ total prescription revenue and dispenses more than 1 billion
prescriptions per year; Walgreens captures about one-fifth. The chains declined
to provide data about the numbers of mistakes made, and much of the information
never becomes public because companies often settle with their victims out of
court, requiring a confidentiality agreement. A CVS form that staff members use
to report errors asks whether the patient is a “media threat”. The last study
made public was in 2006; it concluded that pharmacy mistakes harm 1.5 million
Americans annually.<o:p></o:p></span></span></div>
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<br /></div>
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<span style="background: white; font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">“A fatigued and distracted
pharmacist in a fast-paced, chaotic environment is much more likely to make an
error. The harm from such an error ranges from being a slight inconvenience to
being fatal.”<o:p></o:p></span></span></div>
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<span style="background: white; font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">--An anonymous Texas
pharmacist<o:p></o:p></span></span></div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<a href="https://www.nytimes.com/2020/01/31/health/pharmacists-medication-errors.html"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">https://www.nytimes.com/2020/01/31/health/pharmacists-medication-errors.html</span></a></div>
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<span class="MsoHyperlink"><span style="color: windowtext; font-size: 11pt; text-decoration: none;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;"><br /></span></span></span></div>
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<span class="MsoHyperlink"><span style="color: windowtext; font-size: 11pt; text-decoration: none;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">What can your members do to prevent
errors?<o:p></o:p></span></span></span></div>
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<br /></div>
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<b style="mso-bidi-font-weight: normal;"><u><span style="font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Take an active role in
your health<o:p></o:p></span></span></u></b></div>
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</div>
<ul>
<li style="text-align: justify;"><span style="font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Compare prescription information from your prescriber to the medication you pick up at the pharmacy/ prescriptions delivered to you (if using mail order).</span></span></li>
<li style="text-align: justify;"><span style="font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Familiarize yourself with drug names, dose, dosage forms, and directions to help identify a possible error before it impacts your health.</span></span></li>
<li style="text-align: justify;"><span style="font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Access pharmacy apps and digital tools where you can review your pertinent prescription history.</span></span></li>
</ul>
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<b><u><span style="font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Ask your pharmacist</span></span></u></b></div>
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</div>
<ul>
<li style="text-align: justify;"><span style="font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">One of the most important responsibilities your pharmacist has is patient consultations</span></span></li>
<li style="text-align: justify;"><span style="font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Utilize them as an expert source of information regarding your prescriptions. This allows your pharmacist to take another look to review your prescription to ensure there are no errors.</span></span></li>
</ul>
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<div class="MsoListParagraphCxSpFirst" style="margin-left: .25in; mso-add-space: auto; mso-list: l1 level1 lfo2; text-align: justify; text-indent: -.25in;">
<b><u><span style="font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Utilize free resources</span></span></u></b></div>
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<ul>
<li style="text-align: justify;"><span style="font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Carefully read and examine your prescription label; it contains information about the appearance of the tablets/capsules/liquid etc. </span></span></li>
<li style="text-align: justify;"><span style="font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Cross-reference that to what appears inside the vial.</span></span></li>
<li style="text-align: justify;"><span style="font-size: 11pt;"><span style="font-family: Helvetica Neue, Arial, Helvetica, sans-serif;">Do not assume it is a change in manufacturer or supplier. Free websites like <a href="http://www.drugs.com/" style="font-size: 14.6667px; text-align: justify; text-indent: -24px;">www.drugs.com</a><span style="font-size: 14.6667px; text-align: justify; text-indent: -24px;"> </span><span style="font-size: 14.6667px; text-align: justify; text-indent: -24px;"> </span><span style="font-size: 14.6667px; text-align: justify; text-indent: -24px;">and </span><a href="http://www.webmd.com/" style="font-size: 14.6667px; text-align: justify; text-indent: -24px;">www.WebMD.com</a><span style="font-size: 14.6667px; text-align: justify; text-indent: -24px;"> </span><span style="font-size: 14.6667px; text-align: justify; text-indent: -24px;"> </span><span style="font-size: 14.6667px; text-align: justify; text-indent: -24px;">can help identify drugs.</span></span></span></li>
</ul>
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<br />PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com2tag:blogger.com,1999:blog-1653002039921749625.post-18262358034054131672020-01-25T08:38:00.000-05:002020-01-25T08:38:44.513-05:00<br />
<div align="center" class="MsoNormal" style="text-align: center;">
<b style="mso-bidi-font-weight: normal;"><u><span style="font-family: "Arial",sans-serif;">CORONAVIRUS AS OF
JANUARY 24, 2020<o:p></o:p></span></u></b></div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="background: white; font-family: "Arial",sans-serif;">When a new virus strain emerges that is not yet identified,
as with the Corona Virus, it becomes known as “novel”. <o:p></o:p></span></div>
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<br /></div>
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<span style="background: white; font-family: "Arial",sans-serif;">In 2019, Novel Coronavirus (2019-nCoV) a virus (more
specifically, a </span><span style="font-family: "Arial",sans-serif;"><a href="https://www.cdc.gov/coronavirus/index.html"><span style="color: windowtext; text-decoration: none; text-underline: none;">coronavirus</span></a><span style="background: white;">) was identified as the cause of an outbreak of
respiratory illness first detected in Wuhan, China, a city located about 500 miles
from Shanghai. Early on, many of the patients in the outbreak in Wuhan
reportedly had some link to a large seafood and animal market, suggesting
animal-to-person spread. <span style="mso-spacerun: yes;"> </span>However, a
growing number of patients reportedly did not have exposure to animal markets,
suggesting person-to-person spread is occurring. At this time it is unclear how
easily this virus is spreading between people. The market closed its doors on
Jan. 1, 2020.<o:p></o:p></span></span></div>
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<br /></div>
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<span style="background: white; font-family: "Arial",sans-serif;">China is rushing to build a 1,000 bed hospital in 6 days, as
this virus has killed 26 people and infected about 830 more. The virus has
spread to 13 provinces in China, and cases are confirmed in Thailand, South
Korea, Taiwan, Vietnam, and Singapore. Two cases have now turned up in the U.S.
A Washington state man in his 30s has been diagnosed after returning from a
solo trip to Wuhan and a 60-year old Chicago woman who returned from Wuhan on
Jan. 13<sup>th</sup> is in the hospital and is currently in stable condition
and doing well. The CDC is examining 63 patients in 22 states for possible
coronavirus infection.<o:p></o:p></span></div>
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<br /></div>
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<span style="background: white; font-family: "Arial",sans-serif;">People suspected of carrying the virus are encouraged to wear
an N95 mask to prevent airborne transmission, as well as health providers who
also wear personal protective gear according to the World Health Organization
(WHO) guidelines.<o:p></o:p></span></div>
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<br /></div>
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<span style="background: white; font-family: "Arial",sans-serif;">Starting on January 17, 2020, travelers from Wuhan to the
United States have been required to undergo entry screening at various airports
for symptoms associated with this virus.<span style="mso-spacerun: yes;">
</span>As of January 24, 2020 there are five U.S. airports involved in such
screenings:<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span>San Francisco, New York (JFK), Atlanta,
Chicago, and Los Angeles (LAX) airports. <span style="mso-spacerun: yes;"> </span>The “Center for Disease Control (CDC) believes
the immediate risk to the U.S. public is low at this time, but the situation is
evolving rapidly,” Dr. Nancy Messonnier, director of the National Center for
Immunization and Respiratory Diseases, said on a conference call with reporters
January 24<sup>th</sup>. Nevertheless, CDC is taking proactive preparedness
precautions. <o:p></o:p></span></div>
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<br /></div>
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<span style="background: white; font-family: "Arial",sans-serif;">Snakes, the Chinese krait and the Chinese cobra, may be the
original source of this virus. The name “Coronavirus” comes from its shape,
which resembles a crown or solar corona when imaged using an electron
microscope. Coronavirus is transmitted through the air. It can infect both
upper and lower airways and cause severe respiratory illness and other
complications in humans. </span><span style="background: #FEFEFE; font-family: "Arial",sans-serif;">Unfortunately, there is </span><span style="font-family: "Arial",sans-serif;">no vaccine<span style="background: #FEFEFE;"> or antiviral
treatment available at this time.</span><span style="background: white;"><o:p></o:p></span></span></div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="background: white; font-family: "Arial",sans-serif;">This outbreak is another reminder that people should limit
the consumption of wild animals to avoid zoonotic infections (infections
that spread from animals to humans).<o:p></o:p></span></div>
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<br /></div>
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<span class="MsoHyperlink"><span style="font-family: "Arial",sans-serif;"><a href="https://nypost.com/2020/01/24/coronavirus-in-china-officials-rush-to-build-hospital-in-10-days/?utm_campaign=iosapp&utm_source=mail_app">https://nypost.com/2020/01/24/coronavirus-in-china-officials-rush-to-build-hospital-in-10-days/?utm_campaign=iosapp&utm_source=mail_app</a></span></span><span style="font-family: "Arial",sans-serif;"><o:p></o:p></span></div>
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<br /></div>
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<span class="MsoHyperlink"><span style="font-family: "Arial",sans-serif;"><a href="https://www.cnn.com/2020/01/22/health/snakes-wuhan-coronavirus-outbreak-conversation-partner/index.html">https://www.cnn.com/2020/01/22/health/snakes-wuhan-coronavirus-outbreak-conversation-partner/index.html</a></span></span><span style="font-family: "Arial",sans-serif;"><o:p></o:p></span></div>
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<br /></div>
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<span class="MsoHyperlink"><span style="font-family: "Arial",sans-serif;"><a href="https://www.cdc.gov/coronavirus/index.html">https://www.cdc.gov/coronavirus/index.html</a></span></span><span style="font-family: "Arial",sans-serif;"><o:p></o:p></span></div>
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<br /></div>
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<span class="MsoHyperlink"><span style="font-family: "Arial",sans-serif;"><a href="https://www.cdc.gov/media/releases/2020/p0117-coronavirus-screening.html">https://www.cdc.gov/media/releases/2020/p0117-coronavirus-screening.html</a></span></span><span style="font-family: "Arial",sans-serif;"><o:p></o:p></span></div>
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<br /></div>
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<span class="MsoHyperlink"><span style="font-family: "Arial",sans-serif;"><a href="https://www.cdc.gov/coronavirus/2019-ncov/about/index.html">https://www.cdc.gov/coronavirus/2019-ncov/about/index.html</a></span></span><span style="font-family: "Arial",sans-serif;"><o:p></o:p></span></div>
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<br /></div>
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<span class="MsoHyperlink"><span style="font-family: "Arial",sans-serif;"><a href="https://www.directrelief.org/2020/01/as-authorities-work-to-contain-wuhan-coronavirus-direct-relief-prepares-to-assist/">https://www.directrelief.org/2020/01/as-authorities-work-to-contain-wuhan-coronavirus-direct-relief-prepares-to-assist/</a><o:p></o:p></span></span></div>
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<br /></div>
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<span class="MsoHyperlink"><span style="font-family: "Arial",sans-serif;"><a href="https://nypost.com/2020/01/24/second-us-case-of-coronavirus-confirmed-in-chicago/?utm_campaign=iosapp&utm_source=mail_app">https://nypost.com/2020/01/24/second-us-case-of-coronavirus-confirmed-in-chicago/?utm_campaign=iosapp&utm_source=mail_app</a></span></span><span style="font-family: "Arial",sans-serif;"><o:p></o:p></span></div>
<br />PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com2tag:blogger.com,1999:blog-1653002039921749625.post-39603569602002095732019-09-10T17:14:00.000-04:002019-09-10T17:14:25.581-04:00Generic Insulin<br />
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<span style="font-family: "Arial",sans-serif;">All three of
the major insulin manufacturers (Eli Lilly, Sanofi and Novo Nordisk) have
finally announced plans to lower their insulin prices amid mounting criticism
over their high costs in the United States and patients’ demands for lower cost
options. To date, the manufacturers have put the blame on PBMs by pointing to
declines in their products’ realized price, despite significant list-price
increases.<o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: "Arial",sans-serif;">Novo Nordisk is
the last one to join Eli Lilly and Sanofi in making a cost-cutting move on
their insulin products. <span style="mso-spacerun: yes;"> </span>On September 6<sup>th</sup>,
the Danish company announced that it will <a href="https://www.prnewswire.com/news-releases/novo-nordisk-launching-additional-us-insulin-affordability-offerings-in-january-2020-300913167.html"><span style="color: windowtext; text-decoration: none; text-underline: none;">offer</span></a>
authorized generics of its Novolog brands at a 50 percent discount from their
originators. <o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: "Arial",sans-serif;">Novo will also
offer a $99 cash card program. Regardless of insurance status, patients can buy
3 vials or 2-packs of any Novolog FlexPen or FlexTouch product. This should
cover a one month supply for most patients. These programs will launch in
January 2020.<o:p></o:p></span></div>
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<br /></div>
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<span style="font-family: "Arial",sans-serif;">Lilly’s generic
Humalog product is half the price of the brand; they unveiled it in March 2019.
Lantus maker Sanofi soon followed suit in April by <a href="https://www.fiercepharma.com/pharma/sanofi-unveils-99-per-month-insulin-subscription-program"><span style="color: windowtext; text-decoration: none; text-underline: none;">expanding</span></a> the
Insulin Valyou Savings Program, which lowers the cost of its insulin products
to $99 per month.<o:p></o:p></span></div>
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<br /></div>
<div style="margin: 1.5pt 0in 12pt; text-align: justify;">
<span style="font-family: "Arial",sans-serif;">In 2018 10.1 percent of
adults aged 18 and over had diagnosed diabetes. </span><span style="font-family: "Arial",sans-serif; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin;">The
National Center for Health Statistics published a survey in August 2019: “Strategies
used by Adults with Diagnosed Diabetes to Reduce their Prescription Drug Costs,
2017-2018”. </span><span style="color: black; font-family: "Arial",sans-serif;"><o:p></o:p></span></div>
<div style="margin: 1.5pt 0in 12pt; text-align: justify;">
<span style="font-family: "Arial",sans-serif;">Of significance is that 14.9
percent of women and 11.6 percent of men were more likely to not take their
medication as prescribed to reduce their prescription drug costs. <span style="mso-spacerun: yes;"> </span>Among adults diagnosed with diabetes in the
past twelve months, 13.2 percent did not take their medication as prescribed
and 24.4 percent asked their doctor for a lower cost medication.<span style="mso-spacerun: yes;"> </span>Those <i><u>under age</u></i> 65 were more
likely to take their medication as prescribed and ask their doctor for a lower
cost medication as compared to adults <i><u>over age</u></i> 65.<o:p></o:p></span></div>
<div style="margin: 1.5pt 0in 12pt; text-align: justify;">
<span style="font-family: "Arial",sans-serif;">The percentage of adults who
asked their doctor for a lower cost alternative was highest among those with
private insurance, Medicare Advantage or Medicare only. Those with Medicare and
Medicaid coverage were less likely to ask their doctor for a lower cost
alternative.</span><span style="font-family: "Arial",sans-serif; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin;"><o:p></o:p></span></div>
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<u><span style="color: blue; font-family: "Arial",sans-serif;"><a href="https://www.cdc.gov/nchs/data/databriefs/db349-h.pdf">https://www.cdc.gov/nchs/data/databriefs/db349-h.pdf</a><o:p></o:p></span></u></div>
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<span class="MsoHyperlink"><span style="font-family: "Arial",sans-serif;"><a href="https://www.fiercepharma.com/marketing/novo-nordisk-rolls-out-authorized-insulin-generics-following-similar-moves-by-lilly-and">https://www.fiercepharma.com/marketing/novo-nordisk-rolls-out-authorized-insulin-generics-following-similar-moves-by-lilly-and</a></span></span><span style="font-family: "Arial",sans-serif;"><o:p></o:p></span></div>
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<br />PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com1tag:blogger.com,1999:blog-1653002039921749625.post-76432643845055617202019-07-12T10:40:00.000-04:002019-07-12T10:40:18.198-04:00<br />
<h2 style="text-align: center;">
<span style="color: #303030; font-family: "Arial",sans-serif; font-size: 10.0pt;"><b>Trump Administration Drops Rebate Plan</b></span></h2>
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<span style="color: #303030; font-family: "Arial",sans-serif; font-size: 10.0pt;"><br /></span></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="color: #303030; font-family: "Arial",sans-serif; font-size: 10.0pt;">On July 11, 2019, the Trump
administration announced that it will <b><i>not </i></b>be moving
forward on a proposed rule to eliminate arcane rebates that flow from drug
manufacturers to the PBMs (Pharmacy Benefit Managers). Many employers were
concerned that this ruling would have a trickle down effect and conceivably
mandate that they also would be required to provide rebates for certain drugs
to certain members at Point of Sale. That concern is now alleviated.</span><span style="color: #303030; font-family: "Times New Roman",serif; font-size: 10.0pt;"><o:p></o:p></span></div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="color: #303030; font-family: "Arial",sans-serif; font-size: 10.0pt;">The draft measure, which was
projected to raise federal spending by $177 billion over the next decade, was
poised to prohibit drug rebates for treatments offered in the Medicare and
Medicaid programs beginning in 2020. This drew intense backlash from the PBMs,
whose operations would be significantly impacted by this action. It also drew
praise from drug companies that routinely blame PBMs as the cause of the high
cost of drugs.</span><span style="color: #303030; font-family: "Times New Roman",serif; font-size: 10.0pt;"><o:p></o:p></span></div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="color: #303030; font-family: "Arial",sans-serif; font-size: 10.0pt;">Top PBMs, like CVS Health, warned
that removing the rebates would lead to higher drug costs for seniors, an
outcome that sources say the White House was concerned about before the 2020
elections.</span><span style="color: #303030; font-family: "Times New Roman",serif; font-size: 10.0pt;"><o:p></o:p></span></div>
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<br /></div>
<div class="MsoNormal" style="text-align: justify;">
<span style="color: #303030; font-family: "Arial",sans-serif; font-size: 10.0pt;">In another blow to the
pharmaceutical industry, Trump is weighing an executive order to tie prices for
Medicare Part B drugs to the lowest cost available internationally, an action
that would undermine profits in the sector. </span><span style="color: #303030; font-family: "Times New Roman",serif; font-size: 10.0pt;"><o:p></o:p></span></div>
<br />PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com1tag:blogger.com,1999:blog-1653002039921749625.post-79480297173045770862019-04-22T13:50:00.000-04:002019-04-22T13:50:44.079-04:00<br />
<div align="center" class="MsoNormal" style="text-align: center;">
<span style="font-family: "Proxima Nova"; font-size: 14.0pt; line-height: 107%;"><b>PBIRx has
a New Look!</b><o:p></o:p></span></div>
<div align="center" class="MsoNormal" style="text-align: center;">
<span style="font-family: "Proxima Nova"; font-size: 14.0pt; line-height: 107%;"><b><br /></b></span></div>
<div class="MsoNormal">
<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">We’re still the same company, but we have updated our materials
to better communicate who we are and how our products and services support your
quest for better and more affordable pharmacy benefit plans!<span style="mso-spacerun: yes;"> </span><o:p></o:p></span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;"><span style="mso-spacerun: yes;"><br /></span></span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">Data and creative cost savings solutions require “very
specialized thinking” and we are proud and fortunate of the team we employ with
their varied expertise, intelligence, and longevity in the industry and with
PBIRx.<o:p></o:p></span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg9i_WIm4f_OFoDrgHXGNHifXhAzlt10uXu90B7wk-wEliK4lTcFYw5_Uo_xiHwd3skeLTXY_vx0vXD4A4RYwsdfa4AHtEQq247Xy1GqpgmIFGfX8lIeQLNFPOug5MGaXrcXHWCaoyH0CDM/s1600/PBIRx+with+registered.jpg" imageanchor="1" style="clear: left; float: left; margin-bottom: 1em; margin-right: 1em;"><img border="0" data-original-height="466" data-original-width="1048" height="88" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg9i_WIm4f_OFoDrgHXGNHifXhAzlt10uXu90B7wk-wEliK4lTcFYw5_Uo_xiHwd3skeLTXY_vx0vXD4A4RYwsdfa4AHtEQq247Xy1GqpgmIFGfX8lIeQLNFPOug5MGaXrcXHWCaoyH0CDM/s200/PBIRx+with+registered.jpg" width="200" /></a></div>
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<br /></div>
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<b style="font-family: "Proxima Nova"; font-size: 12pt;"><span style="font-size: 12pt; line-height: 107%;">Bold</span></b><span style="font-family: "Proxima Nova"; font-size: 12pt; line-height: 107%;">
letter forms represent our confidence and tenacity in everything we do.</span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal">
<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">The <b style="mso-bidi-font-weight: normal;">Brain </b>represents
our capacity to combine our comprehensive and analytical understanding of
pharmacy benefits.<span style="mso-spacerun: yes;"> </span>Our recommendations
are based on right-brain/left-brain thinking.<o:p></o:p></span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">The <b style="mso-bidi-font-weight: normal;">Tablets</b>
represent our focus on medications, formularies and clinical recommendation
that provide better member benefit and health outcomes.<o:p></o:p></span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">The <b style="mso-bidi-font-weight: normal;">Gradient Colors</b>
represent the dynamic, fast changing healthcare landscape.<o:p></o:p></span></div>
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<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">PBI</span></b><span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;"> stands
for Pharmacy Benefit Intelligence, which is what we live and what we deliver.<o:p></o:p></span></div>
<div class="MsoNormal">
<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal">
<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;">Our focus continues to be on our clients.<span style="mso-spacerun: yes;"> </span>We evaluate current drug usage and spend,
claim by claim, and then model and present alternative opportunities customized
for each client which can yield measurable plan and member savings enhancing
benefits while delivering optimum health outcomes.<o:p></o:p></span></div>
<div class="MsoNormal">
<span style="font-family: "Proxima Nova"; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal">
<br /></div>
<div class="Normal1">
<i style="mso-bidi-font-style: normal;"><span style="color: windowtext; font-family: "Calibri",sans-serif; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin;">PBIRx® has
been exclusively providing intelligent solutions to clients in the management
of pharmacy benefit costs since 1993. With a staff that includes IT personnel,
actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA
Compliance Officers and many more experts, PBIRx’s mission is to create optimal
healthcare outcomes while minimizing overall healthcare costs. For more
information, please visit <span class="MsoHyperlink"><span style="color: windowtext; text-decoration: none; text-underline: none;"><a href="http://www.pbirx.com/"><span style="color: windowtext; text-decoration: none; text-underline: none;">www.pbirx.com</span></a></span></span>
or call (888) 797-2479.<o:p></o:p></span></i></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<br /></div>
<br />PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com2tag:blogger.com,1999:blog-1653002039921749625.post-80657259303926935002019-04-17T16:23:00.002-04:002019-04-17T16:23:34.692-04:00Two New Drugs for Multiple Sclerosis<br />
<h2 style="text-align: center;">
<span style="background-color: white; font-family: Arial, sans-serif; font-size: 10.5pt;">Two New Drugs for Multiple Sclerosis</span></h2>
<div class="MsoNormal">
<span style="background-color: white; font-family: Arial, sans-serif; font-size: 10.5pt;">The FDA has recently approved two
new oral drugs for the treatment of Multiple Sclerosis (MS).</span></div>
<div class="MsoNormal">
<span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 10.5pt; line-height: 107%;">Over the last few years, three
oral drugs for MS have become available: Gilenya came to the US market in 2010;
Aubagio was released in 2012; and Tecfidera in 2013. Prior to that, all
therapies were injectables. <o:p></o:p></span></div>
<div class="MsoNormal">
<span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 10.5pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal">
<span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 10.5pt; line-height: 107%;">Mavenclad (cladribine), an
oral form of an older drug, given intravenously for certain types of leukemia,
was FDA approved for the treatment of relapsing forms of MS <span style="mso-spacerun: yes;"> </span>including active secondary progressive disease
in adults. As a result of its safety profile, it’s generally recommended for
patients who have had an inadequate response to, or are unable to tolerate, an
alternate drug indicated for the treatment of MS. Treatment with Mavenclad may
increase the risk of malignancy. <o:p></o:p></span></div>
<div class="MsoNormal">
<span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 10.5pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal">
<span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 10.5pt; line-height: 107%;">Uniquely, Mavenclad is only administered
twice over four or five days, for two treatment courses which are spaced about
a year apart. After that, the patient doesn’t receive any medication for at
least two years. The dose is weight-based; the total annual cost for an average
80kg person (176 lbs) is $127,900. Though it’s given much less frequently than
any of the other currently available monthly oral medications, it is more
expensive per month ($10,661).<o:p></o:p></span></div>
<div class="MsoNormal">
<span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 10.5pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal">
<span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 10.5pt; line-height: 107%;">Mayzent (siponimod), was
approved for the same indication. The dose is also unusual: 0.25 mg once daily
on Days 1 and 2; 0.5 mg once daily on Day 3; 0.75 mg once daily on Day 4; 1.25
mg once daily on Day 5. The maintenance dose is 2 mg once daily beginning on
Day 6. The monthly cost is $8,729.<o:p></o:p></span></div>
<div class="MsoNormal">
<span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 10.5pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal">
<span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 10.5pt; line-height: 107%;">Only time will tell how these
two new drugs will perform in the Multiple Sclerosis landscape.<o:p></o:p></span></div>
<div class="MsoNormal">
<span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 10.5pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal">
<span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 10.5pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal">
<span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 10.5pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal">
<br /></div>
<div class="Normal1">
<i style="mso-bidi-font-style: normal;"><span style="color: windowtext; font-family: "Calibri",sans-serif; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin;">PBIRx has
been exclusively providing intelligent solutions to clients in the management
of pharmacy benefit costs since 1993. With a staff that includes IT personnel,
actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA
Compliance Officers and many more experts, PBIRx’s mission is to create optimal
healthcare outcomes while minimizing overall healthcare costs. For more
information, please visit <span class="MsoHyperlink"><span style="color: windowtext; text-decoration: none; text-underline: none;"><a href="http://www.pbirx.com/"><span style="color: windowtext; text-decoration: none; text-underline: none;">www.pbirx.com</span></a></span></span>
or call (888) 797-2479.<o:p></o:p></span></i></div>
<br />PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com2tag:blogger.com,1999:blog-1653002039921749625.post-494174223576942462019-03-27T11:42:00.000-04:002019-03-27T11:42:05.970-04:00<div style="text-align: center;">
<b>Purdue Pharma to Pay $270 Million in Historic Lawsuit</b></div>
<div style="text-align: center;">
<br /></div>
<div style="text-align: left;">
Purdue Pharma has reached a settlement with the State of Oklahoma over claims the maker of the painkiller OxyContin helped fuel an opioid epidemic that killed thousands of residents in the state. </div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
Of the $270 million, nearly $200 million will go toward establishing the National Center for Addiction Studies and Treatment at Oklahoma State University in Tulsa, while local governments will receive $12.5 million. Twenty million dollars will be set aside for addiction treatment medication, and the remaining $60 million will pay for the state's litigation costs to date.</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
Purdue, the make of OxyContin since 1996, faces more than 1,000 lawsuits in connection with the opioid crisis. The Oklahoma deal is the first settlement to emerge from the thicket of lawsuits.</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
Drugs like OxyContin, along with illegal opioids such as heroin, were linked to a record 48,000 deaths across the United States in 2017 according to the CDC. In Oklahoma, some 400 deaths were related to opioids that year. According to state figures, more Oklahomans have died from opioids over the last decade than vehicle accidents.</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
Purdue Pharma is reportedly considering bankruptcy.</div>
<div style="text-align: left;">
<br /></div>
<div class="Normal1">
<span class="MsoHyperlink"><a href="https://www.cbsnews.com/news/purdue-pharma-lawsuit-opioid-maker-settles-with-state-of-oklahoma/">https://www.cbsnews.com/news/purdue-pharma-lawsuit-opioid-maker-settles-with-state-of-oklahoma/</a></span><i style="mso-bidi-font-style: normal;"><span style="color: windowtext; font-family: "calibri" , sans-serif; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin;"><o:p></o:p></span></i></div>
<br />
<br />
<div class="Normal1">
<i style="mso-bidi-font-style: normal;"><span style="color: windowtext; font-family: "Calibri",sans-serif; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin;">PBIRx has
been exclusively providing intelligent solutions to clients in the management
of pharmacy benefit costs since 1993. With a staff that includes IT personnel,
actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA
Compliance Officers and many more experts, PBIRx’s mission is to create optimal
healthcare outcomes while minimizing overall healthcare costs. For more
information, please visit <span class="MsoHyperlink"><span style="color: windowtext; text-decoration: none; text-underline: none;"><a href="http://www.pbirx.com/"><span style="color: windowtext; text-decoration: none; text-underline: none;">www.pbirx.com</span></a></span></span>
or call (888) 797-2479.<o:p></o:p></span></i></div>
<br />PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com1tag:blogger.com,1999:blog-1653002039921749625.post-57510683383621755462018-12-06T09:55:00.001-05:002018-12-06T09:55:11.942-05:00Vitrakvi Drug - $32,000 per Month<br />
<div class="MsoNormal">
<span style="background: white; color: black; font-family: "Helvetica",sans-serif; font-size: 10.5pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal">
<span style="background: white; color: black; font-family: "Helvetica",sans-serif; font-size: 10.5pt; line-height: 107%;">On November 26, 2018, the
FDA granted accelerated approval for Vitrakvi (larotrectinib), the first-ever neurotrophic
receptor tyrosine kinase inhibitor. </span><span style="background: white; font-family: "Helvetica",sans-serif; font-size: 10.5pt; line-height: 107%;">Vitrakvi
is also the first treatment to receive a “tumor-agnostic” (not specific to an
area of the body) indication at the time of initial FDA approval. <o:p></o:p></span></div>
<div class="MsoNormal">
<span style="background: white; font-family: "Helvetica",sans-serif; font-size: 10.5pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal">
<span style="background: white; font-family: "Helvetica",sans-serif; font-size: 10.5pt; line-height: 107%;">Research has shown that the NTRK genes
can become fused to other genes abnormally, resulting in growth signals that
support the growth of tumors. NTRK fusions are rare but occur in cancers
arising in many sites of the body. <o:p></o:p></span></div>
<div class="MsoNormal">
<span style="background: white; font-family: "Helvetica",sans-serif; font-size: 10.5pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal">
<span style="background: white; font-family: "Helvetica",sans-serif; font-size: 10.5pt; line-height: 107%;">"(This) approval marks another
step in an important shift toward treating cancers based on their tumor
genetics rather than their site of origin in the body," said FDA
Commissioner Scott Gottlieb, M.D. "This new site-agnostic oncology therapy
isn’t specific to a cancer arising in a particular body organ, such as breast
or colon cancer. Its approval reflects advances in the use of biomarkers to
guide drug development and the more targeted delivery of medicine.”<o:p></o:p></span></div>
<div class="MsoNormal">
<span style="background: white; font-family: "Helvetica",sans-serif; font-size: 10.5pt; line-height: 107%;"><br /></span></div>
<div class="MsoNormal">
<span style="background: white; font-family: "Helvetica",sans-serif; font-size: 10.5pt; line-height: 107%;">The full indication for Vitrakvi is
intricate. It is to be used for the treatment of adult and pediatric patients
with solid tumors that:<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpFirst" style="mso-list: l0 level1 lfo1; text-indent: -.25in;">
</div>
<ul>
<li><span style="font-size: 7pt; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span><span style="background: white; font-family: Helvetica, sans-serif; font-size: 10.5pt; line-height: 107%; text-indent: -0.25in;">have a neurotrophic
receptor tyrosine kinase (NTRK) gene fusion</span></li>
<li><span style="font-size: 7pt; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span><span style="background: white; font-family: Helvetica, sans-serif; font-size: 10.5pt; line-height: 107%; text-indent: -0.25in;">are without a known
acquired resistance mutation</span></li>
<li><span style="font-size: 7pt; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span><span style="background: white; font-family: Helvetica, sans-serif; font-size: 10.5pt; line-height: 107%; text-indent: -0.25in;">are metastatic</span></li>
</ul>
<!--[if !supportLists]--><br />
<div class="MsoListParagraphCxSpMiddle">
<span style="background: white; font-family: "Helvetica",sans-serif; font-size: 10.5pt; line-height: 107%;">Or<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpMiddle" style="mso-list: l0 level1 lfo1; text-indent: -.25in;">
</div>
<ul>
<li><span style="font-size: 7pt; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span><span style="background: white; font-family: Helvetica, sans-serif; font-size: 10.5pt; line-height: 107%; text-indent: -0.25in;">where surgical resection
is likely to result in severe morbidity</span></li>
<li><span style="font-size: 7pt; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span><span style="background: white; font-family: Helvetica, sans-serif; font-size: 10.5pt; line-height: 107%; text-indent: -0.25in;">have no satisfactory
alternative treatments</span></li>
</ul>
<!--[if !supportLists]--><br />
<div class="MsoListParagraphCxSpMiddle">
<span style="background: white; font-family: "Helvetica",sans-serif; font-size: 10.5pt; line-height: 107%;">Or<o:p></o:p></span></div>
<div class="MsoListParagraphCxSpLast" style="mso-list: l0 level1 lfo1; text-indent: -.25in;">
</div>
<ul>
<li><span style="font-size: 7pt; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;"> </span><span style="background: white; font-family: Helvetica, sans-serif; font-size: 10.5pt; line-height: 107%; text-indent: -0.25in;">have progressed following
treatment.</span></li>
</ul>
<!--[if !supportLists]--><br />
<div style="background: white; margin-bottom: 12.0pt; margin-left: 0in; margin-right: 0in; margin-top: 12.0pt;">
<span style="font-family: "Helvetica",sans-serif; font-size: 10.5pt;">Vitrakvi
demonstrated a 75% overall response rate across different types of solid
tumors. These responses were durable, with 73% of responses lasting at least
six months, and 39% lasting a year or more at the time results were analyzed.
Examples of tumor types with an NTRK fusion that responded to Vitrakvi include
soft tissue sarcoma, salivary gland cancer, infantile fibrosarcoma, thyroid
cancer and lung cancer.<o:p></o:p></span></div>
<div style="background: white; margin-bottom: 12.0pt; margin-left: 0in; margin-right: 0in; margin-top: 12.0pt;">
<span style="font-family: "Helvetica",sans-serif; font-size: 10.5pt;">Vitrakvi
comes with a hefty price tag: $32,000 per month. Bayer will help patients with
copays and will provide free drug if the patient cannot afford it. Along the
lines of value-based care, Bayer will also refund money spent by insurers or
government payers if there is no clinical improvement in the first 3 months of
treatment.<o:p></o:p></span></div>
<div style="background: white; margin-bottom: 12.0pt; margin-left: 0in; margin-right: 0in; margin-top: 12.0pt;">
<span style="font-family: "Helvetica",sans-serif; font-size: 10.5pt;">One
reason the drug is so expensive is because this condition is very rare. <span style="mso-spacerun: yes;"> </span>Bayer estimates only 2,500 to 3,000 patients
in the U.S. develop cancer due to a TRK fusion each year. <o:p></o:p></span></div>
<div class="MsoListParagraph">
<span style="background: white; font-family: "Helvetica",sans-serif; font-size: 10.5pt; line-height: 107%;"><o:p>For more information: </o:p></span></div>
<div class="Normal1">
<span class="MsoHyperlink"><span style="font-family: "Calibri",sans-serif; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin;"><a href="https://www.prnewswire.com/news-releases/fda-approves-vitrakvi-larotrectinib-the-first-ever-trk-inhibitor-for-patients-with-advanced-solid-tumors-harboring-an-ntrk-gene-fusion1-2-300755551.html">https://www.prnewswire.com/news-releases/fda-approves-vitrakvi-larotrectinib-the-first-ever-trk-inhibitor-for-patients-with-advanced-solid-tumors-harboring-an-ntrk-gene-fusion1-2-300755551.html</a><o:p></o:p></span></span></div>
<div class="Normal1">
<br /></div>
<div class="Normal1">
<span class="MsoHyperlink"><span style="font-family: "Calibri",sans-serif; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin;"><a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626710.htm">https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626710.htm</a><o:p></o:p></span></span></div>
<div class="Normal1">
<br /></div>
<div class="Normal1">
<span class="MsoHyperlink"><span style="font-family: "Calibri",sans-serif; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin;">https://www.forbes.com/sites/matthewherper/2018/11/26/loxo-and-bayers-amazing-drug-has-an-expensive-price/#770ebfb624d0 <o:p></o:p></span></span></div>
<div class="Normal1">
<br /></div>
<div class="Normal1">
<i style="mso-bidi-font-style: normal;"><span style="color: windowtext; font-family: "Calibri",sans-serif; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin;">PBIRx has
been exclusively providing intelligent solutions to clients in the management
of pharmacy benefit costs since 1993. With a staff that includes IT personnel,
actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA
Compliance Officers and many more experts, PBIRx’s mission is to create optimal
healthcare outcomes while minimizing overall healthgcare costs. For more
information, please visit <span class="MsoHyperlink"><span style="color: windowtext; text-decoration: none; text-underline: none;"><a href="http://www.pbirx.com/"><span style="color: windowtext; text-decoration: none; text-underline: none;">www.pbirx.com</span></a></span></span>
or call (888) 797-2479.<o:p></o:p></span></i></div>
<div class="MsoNormal">
<br /></div>
<br />PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com39tag:blogger.com,1999:blog-1653002039921749625.post-56251397193796680932018-09-07T15:01:00.001-04:002018-09-07T15:01:21.182-04:00Flu Season 2018-2019<br />
<div align="center" class="MsoNormal" style="text-align: center;">
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<div align="center" class="MsoNormal" style="text-align: center;">
<span style="font-size: 14.0pt; line-height: 107%;"><o:p><br /></o:p></span></div>
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<span style="font-size: 14.0pt; line-height: 107%;"><o:p><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg_RYMsxiu7WVt6ozkS5rBckdt_-JcLO0xwnIthfKNB5cWRKgc0FSOqPiPaNwmyEHerts03QrMIt-O2nFwyurvvjnK-Los37jaR9ILkeMt_Ac5KJRBMs_BVxA3TbPyvY4V7RaO1Jha6GCPO/s1600/PBIrx_smallerlogo_rgb.jpg" imageanchor="1" style="font-size: medium; margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="266" data-original-width="609" height="86" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg_RYMsxiu7WVt6ozkS5rBckdt_-JcLO0xwnIthfKNB5cWRKgc0FSOqPiPaNwmyEHerts03QrMIt-O2nFwyurvvjnK-Los37jaR9ILkeMt_Ac5KJRBMs_BVxA3TbPyvY4V7RaO1Jha6GCPO/s200/PBIrx_smallerlogo_rgb.jpg" width="200" /></a></o:p></span></div>
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<span style="font-size: 14.0pt; line-height: 107%;">Flu Season 2018-2019<o:p></o:p></span></div>
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<span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 12.0pt; line-height: 107%;">Influenza viruses typically
circulate in the United States annually, most commonly from late fall through
early spring. Most who are diagnosed with the flu will recover without any real
issues; however, influenza can cause serious illness, hospitalization, and
death, particularly among older adults, very young children, pregnant women,
and those with certain chronic medical conditions.<o:p></o:p></span></div>
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<span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
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<span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 12.0pt; line-height: 107%;">Routine annual influenza
vaccination of all persons aged ≥6 months without contraindications continues
to be recommended. No preferential recommendation is made for one influenza
vaccine product over another. <o:p></o:p></span></div>
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<span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
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<span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 12.0pt; line-height: 107%;">There are different types of
vaccines available:<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="color: black; font-family: "Arial",sans-serif; font-size: 12.0pt; mso-fareast-font-family: Arial;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 12.0pt;">Trivalent (3 strain) variety:<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="color: black; font-family: "Arial",sans-serif; font-size: 12.0pt; mso-fareast-font-family: Arial;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 12.0pt;">Standard 3 strain shot (for ages 18-64)<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="color: black; font-family: "Arial",sans-serif; font-size: 12.0pt; mso-fareast-font-family: Arial;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 12.0pt;">High-dose 3 strain shot (for ages 65 and older)<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="color: black; font-family: "Arial",sans-serif; font-size: 12.0pt; mso-fareast-font-family: Arial;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 12.0pt;">Recombinant egg-free 3 strain shot (for ages 18
and older and pregnant women)<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="color: black; font-family: "Arial",sans-serif; font-size: 12.0pt; mso-fareast-font-family: Arial;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 12.0pt;">Quadvalent (4 strain) variety<o:p></o:p></span></div>
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</span></span></span><!--[endif]--><span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 12.0pt;">Intradermal (under the skin) version<o:p></o:p></span></div>
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<!--[if !supportLists]--><span style="color: black; font-family: "Arial",sans-serif; font-size: 12.0pt; mso-fareast-font-family: Arial;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 12.0pt;">Standard 4 strain shot (for ages 4 and older)<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: 1.0in; margin-right: 0in; margin-top: 0in; mso-list: l0 level2 lfo1; tab-stops: list 1.0in; text-indent: -.25in; vertical-align: baseline;">
<!--[if !supportLists]--><span style="color: black; font-family: "Arial",sans-serif; font-size: 12.0pt; mso-fareast-font-family: Arial;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt "Times New Roman";">
</span></span></span><!--[endif]--><span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 12.0pt;">Recombinant 4 strain shot (for ages 18 and older
and pregnant women<o:p></o:p></span></div>
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<span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 12.0pt; line-height: 107%;">Due to the unpredictability of
timing of the onset of the flu season, and concerns that vaccine-induced
immunity might diminish over the course of a season, it is recommended that
vaccination should be offered by the end of October. Children aged 6 months
through 8 years who require 2 doses should receive their first dose as soon as
possible after the vaccine becomes available, to allow the second dose (which
must be administered ≥4 weeks later) to be received before the end of
October. Re-vaccination later in the season of persons who have already
been fully vaccinated is not recommended. <o:p></o:p></span></div>
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<span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 12.0pt; line-height: 107%;"><br /></span></div>
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<span style="background: white; color: black; font-family: "Arial",sans-serif; font-size: 12.0pt; line-height: 107%;">Optimally, vaccination should be
received before flu activity is seen in the community. The ideal time to start
vaccinating cannot be predicted because the timing of the onset, peak, and
decline of influenza activity varies; more than one outbreak might occur in a
given community in a single year. In the United States, localized outbreaks
that indicate the start of seasonal influenza activity can occur as early as
October.<span style="mso-spacerun: yes;"> </span>About 75 percent of the past
seasons saw a peak of influenza occur in January or later, sometimes even as
late as February.<o:p></o:p></span></div>
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<span style="background-color: white; font-family: Arial, sans-serif; font-size: 12pt;">It is important to take
preventive actions to stop the spread of germs during the flu season.</span><span style="font-family: Arial, sans-serif; font-size: 12pt;"> </span><span style="background-color: white; font-family: Arial, sans-serif; font-size: 12pt;">The CDC recommends staying at home for at
least 24 hours after fever is gone, cover your nose and mouth when coughing or
sneezing, wash hands often with soap and water (alcohol based hand rub will do
if water is not available) and clean and disinfect surfaces and objects that
may become contaminated.</span></div>
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<span class="MsoHyperlink"><span style="font-size: 12.0pt; line-height: 115%; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin;"><a href="https://www.cdc.gov/flu/index.htm">https://www.cdc.gov/flu/index.htm</a><o:p></o:p></span></span></div>
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<span class="MsoHyperlink"><span style="font-size: 12.0pt; line-height: 115%; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin;"><a href="https://www.cdc.gov/mmwr/volumes/67/rr/rr6703a1.htm?s_cid=rr6703a1_w">https://www.cdc.gov/mmwr/volumes/67/rr/rr6703a1.htm?s_cid=rr6703a1_w</a></span></span><span style="color: windowtext; font-size: 12.0pt; line-height: 115%; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin;"><o:p></o:p></span></div>
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<br /></div>
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<i style="mso-bidi-font-style: normal;"><span style="color: windowtext; font-family: "Calibri",sans-serif; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin;">PBIRx has
been exclusively providing intelligent solutions to clients in the management
of pharmacy benefit costs since 1993. With a staff that includes IT personnel,
actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA
Compliance Officers and many more experts, PBIRx’s mission is to create optimal
health care outcomes while minimizing overall health care costs. For more
information, please visit <span class="MsoHyperlink"><span style="color: windowtext; text-decoration: none; text-underline: none;"><a href="http://www.pbirx.com/"><span style="color: windowtext; text-decoration: none; text-underline: none;">www.pbirx.com</span></a></span></span>
or call (888) 797-2479.<o:p></o:p></span></i></div>
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<br />PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com489tag:blogger.com,1999:blog-1653002039921749625.post-941881819029137842018-06-08T09:35:00.000-04:002018-06-08T09:35:37.991-04:00To Promote Lower Cost Drugs Including High Cost Specialty Meds, FDA Publishes Two New Draft Guidances<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiiY1qOSkhMOAqKc7uxg4DuoXBPL-aJi9uO7JIoh49TDrredSVdUvb1OEv0PBPr-cP2p_gIOKOs0yq4sRSd-SFfeo45RnLbyUlEZDMRA7GnKrI93lD64nPhLBhp6vA4XAg-KW-R74oVF5Aw/s1600/Orkambi.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="1066" data-original-width="1600" height="133" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiiY1qOSkhMOAqKc7uxg4DuoXBPL-aJi9uO7JIoh49TDrredSVdUvb1OEv0PBPr-cP2p_gIOKOs0yq4sRSd-SFfeo45RnLbyUlEZDMRA7GnKrI93lD64nPhLBhp6vA4XAg-KW-R74oVF5Aw/s200/Orkambi.jpg" width="200" /></a></div>
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<span style="color: windowtext; font-family: "Calibri",sans-serif; font-size: 11.0pt;">On June 1<sup>st</sup>, the FDA published two
new "draft guidance" documents, which are recommendations for
review and comments to address one of the many complex obstacles to timely
generic and biologic drug launches.<span style="mso-spacerun: yes;">
</span>Some of these obstacles are related to the current Risk Evaluation and
Mitigation Strategies (<b>REMS)</b> program developed by the Brand
manufacturer. After 60 days, the "draft guidance" comments
will be evaluated and new policies will be voted on and become effective with
the goal to bring lower cost generics and biologics to the market sooner.<o:p></o:p></span></div>
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<span style="color: windowtext; font-family: "Calibri",sans-serif; font-size: 11.0pt;">Currently the FDA requires <b><i>certain </i></b>Brand
medications to have a REMS program provided prior to the approval of the
drug. The REMS document outlines serious safety concerns and
employs tools beyond prescribing information to ensure that the benefits of a
medication outweigh its risks. <o:p></o:p></span></div>
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<span style="color: windowtext; font-family: "Calibri",sans-serif; font-size: 11.0pt;">The FDA may also require certain "Elements To Assure
Safe Use" (ETASU) such as requiring the provider to have specific training
or experience, that patients using the drug be monitored, or that the drug is
dispensed to patients with evidence of other documentation of safe-use
conditions. The ETASU may also include a system for the applicant to
monitor, evaluate and improve a subscribed drug implementation.
Lastly, a REMS document must have a timetable for submission of assessments of
the strategy.</span><span style="color: windowtext;"> </span><span style="color: windowtext; font-family: "Calibri",sans-serif; font-size: 11.0pt;"><a href="https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609045.pdf">https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609045.pdf</a> </span><span style="color: windowtext; font-family: "Calibri",sans-serif; font-size: 11.0pt;"><o:p></o:p></span></div>
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<span style="color: windowtext; font-family: "Calibri",sans-serif; font-size: 11.0pt;">Once the period of Brand patent protection or exclusivity has
lapsed, it seems that generic and biosimilar drug competition is not
materializing judiciously. Sometimes this is due to Brand drug
manufacturers' tactics before and after the generic or biologic drug
manufacturer seeks approval for market entry. One example is restricting
the sale of the Brand drug to the generic or biologic manufacturer, which typically
requires an estimated 5,000 doses in order to run bioequivalence and
bioavailability studies to prove that the generic is the same as the Brand. <span style="mso-spacerun: yes;"> </span><o:p></o:p></span></div>
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<span style="color: windowtext; font-family: "Calibri",sans-serif; font-size: 11.0pt;">Mylan, one of the largest generic manufacturers, recently
sued Celgene over their refusal to share samples of Revlimed, which costs
approximately $180,000 per year.<span style="mso-spacerun: yes;"> </span>In
2016, its third year on the market, Revlimed had $6.97B in sales, and given the
initial $800M on research and development, Celgene continues to reap a
significant ROI. The expiration date for the patent will be 2019, but Celgene’s
delay strategies could allow the company to put off unrestricted competition
from generics until 2026, which could cost an extra $45B to patients who need
this cancer drug.<span style="mso-spacerun: yes;"> </span><span style="mso-spacerun: yes;"> </span></span><span style="color: windowtext; font-family: "Calibri",sans-serif; font-size: 11.0pt;"><a href="https://www.bloomberg.com/news/features/2017-12-20/the-loopholes-drug-companies-use-to-keep-prices-high">https://www.bloomberg.com/news/features/2017-12-20/the-loopholes-drug-companies-use-to-keep-prices-high</a> </span><span style="color: windowtext; font-family: "Calibri",sans-serif; font-size: 11.0pt;"><span style="mso-spacerun: yes;"> </span><o:p></o:p></span></div>
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<span style="color: windowtext; font-family: "Calibri",sans-serif; font-size: 11.0pt;"><a href="https://khn.org/news/drugmakers-blamed-for-blocking-generics-have-milked-prices-and-cost-u-s-billions/">https://khn.org/news/drugmakers-blamed-for-blocking-generics-have-milked-prices-and-cost-u-s-billions/</a> </span><span style="color: windowtext; font-family: "Calibri",sans-serif; font-size: 11.0pt;"><o:p></o:p></span></div>
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<span style="color: windowtext; font-family: "Calibri",sans-serif; font-size: 11.0pt;">After bioequivalency has been determined, Brand manufacturers
make the negotiation time between the Brand and generic or biologic drug
applicant a lengthy process often resulting in litigation.<span style="mso-spacerun: yes;"> </span>This causes delays in the approval of the
generic or biologic. Brand manufacturers have used this litigation
to their advantage delaying market entry. <o:p></o:p></span></div>
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<span style="color: windowtext; font-family: "Calibri",sans-serif; font-size: 11.0pt;">The FDA's new "draft guidances" are an effort to
address these issues currently delaying generic and biologic drug competition.
The two new FDA "draft guidances" are: 1) "<b><i>Development
of a Shared System REMS Guidance for Industry</i>"</b> and 2) "<b><i>Waivers
of the Single, Shared System REMS Requirement Guidance for Industry</i></b>".<span style="mso-spacerun: yes;"> </span>The objective is to shorten the time that a
generic or biologic can launch. In the first "draft guidance" Brand
and generic/biologic applicants are encouraged to use <b><i>an industry working
group</i></b> (IWG) or third party to expedite negotiations and develop a <b><i>shared
REMS Guidance and ETASU. </i></b>The second "draft
guidance" allows the generic manufacturer an option to seek a <b><i>waiver
</i></b>to obtain a separate and comparable REMS policy with ETASU in certain
situations where the Brand manufacturer is not cooperating. </span><span style="color: windowtext; font-family: "Calibri",sans-serif; font-size: 11.0pt;"><a href="https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609048.pdf">https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609048.pdf</a> </span></div>
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<span style="color: windowtext; font-family: "Calibri",sans-serif; font-size: 11.0pt;"><o:p></o:p></span><br />
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<span style="color: windowtext; font-family: "Calibri",sans-serif; font-size: 11.0pt;">These guidance reports are expected to translate to new
policies and will be a major opportunity for client and member savings as they
will allow <i style="mso-bidi-font-style: normal;">lower cost </i>generics and
biosimilars to come to market earlier.<span style="mso-spacerun: yes;"> </span>High
cost biologics continue to represent not only 40%-50% of total pharmacy benefit
dollars, but also a large percentage of medical costs i.e. infused drugs and
drugs bought and billed by physicians.<span style="mso-spacerun: yes;"> </span>However,
physicians will have to agree that biologics are safe and that patients equally
feel comfortable being prescribed a biologic versus the Brand reference or
originator drug.<o:p></o:p></span></div>
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<span style="color: windowtext; font-family: "Calibri",sans-serif; font-size: 11.0pt;"><span style="mso-spacerun: yes;"> </span>At the same time Pharmacy
Benefit Managers have a tremendous amount of control given that they develop
formularies with preferred drugs from manufacturers who provide the highest
rebate including some of the currently few biosimilars approved in the United
States.<span style="mso-spacerun: yes;"> </span>As biosimilars come to market
sooner, losers will be the clients who are not using an independent pharmacy
benefit consulting firm, thus leaving thousands of dollars as PBM profits for
shareholders because they signed a three year PBM agreement<b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">, which has language excluding biosimilars</i></b>
<b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;">from
rebates. </i></b><o:p></o:p></span></div>
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<div class="Normal1">
<i style="mso-bidi-font-style: normal;"><span style="color: windowtext; font-family: "Calibri",sans-serif; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin;">PBIRx has
been exclusively providing intelligent solutions to clients in the management
of pharmacy benefit costs since 1993. With a staff that includes IT personnel,
actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA
Compliance Officers and many more experts, PBIRx’s mission is to create optimal
health care outcomes while minimizing overall health care costs. For more
information, please visit </span></i><a href="http://www.pbirx.com/"><i style="mso-bidi-font-style: normal;"><span style="color: windowtext; font-family: "Calibri",sans-serif; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; text-decoration: none; text-underline: none;">www.pbirx.com</span></i></a><i style="mso-bidi-font-style: normal;"><span style="color: windowtext; font-family: "Calibri",sans-serif; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin;"> or call (888) 797-2479.<o:p></o:p></span></i></div>
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<br />PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com36tag:blogger.com,1999:blog-1653002039921749625.post-2318955907759653442018-05-25T13:03:00.001-04:002018-05-25T13:07:17.009-04:00Aimovig® - The First In A New Class of Drugs to Prevent Migraines<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhzlGz0r37bLt-bRyZvv3wA4TsR33UQZ8LXQb2UFfDNRYdg1YxLPqlCdid-1E_hLq75KMYKMXt3uf4sU8T2NoN6Eh40Zp4U5e-SyGLEKGsmuCLXuzNgywsw4F0UB2mG2-lTsxY2E1AjgC5J/s1600/shutterstock_566085970.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="667" data-original-width="1000" height="213" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhzlGz0r37bLt-bRyZvv3wA4TsR33UQZ8LXQb2UFfDNRYdg1YxLPqlCdid-1E_hLq75KMYKMXt3uf4sU8T2NoN6Eh40Zp4U5e-SyGLEKGsmuCLXuzNgywsw4F0UB2mG2-lTsxY2E1AjgC5J/s320/shutterstock_566085970.jpg" width="320" /></a></div>
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Novartis and Amgen announce FDA approval for Aimovig (erenumab-aooe), the first approved medication of its kind to be prescribed “prophylactially to “prevent” migraine headaches. The cost will be approximately $6,000 -$14,000 annually. <br /><br />There are potentially more than 1M candidates, as there are many migraine sufferers who do not get relief from conventional medications, such as Imitrex or Zomig (known as “triptans”). It is also estimated that less than half of all migraine sufferers get relief from prophylactic medications that are currently available.<br /><br />The Pharmacy Times states that “Migraine headache is a <a href="http://www.pharmacytimes.com/resource-centers/pain">painful</a> condition that has a negative impact on a patient’s well-being and can reduce their ability to do their job or participate in other activities."<br /><a href="https://www.pharmacytimes.com/contributor/ryan-chandanais-ms-cpht/2018/01/migraine-headache-a-look-at-current-treatments-and-the-pipeline">https://www.pharmacytimes.com/contributor/ryan-chandanais-ms-cpht/2018/01/migraine-headache-a-look-at-current-treatments-and-the-pipeline</a><br /><br />Aimovig is in a new class of drugs called CGRPs (Calcitonin Gene-Related Peptide Receptor) Antagonist. This drug class works by blocking calcitonin gene-related peptide (CGRP), which is released during a migraine and is administered by subcutaneous injection, 1-2 times/month by the patient. Amgen provides the SureClick AutoInjector for the Aimovig. The two dosage forms available are 70 mg and 140mg. <br /><br />In a 6-month study with 955 patients, Aimovig showed a statistically significant decrease in the number of migraines. Novartis states that Aimovig was reduced monthly migraine days, including in more difficult to treat populations, with many patients achieving at least a 50% reduction. <a href="https://www.novartis.com/news/media-releases/novartis-and-amgen-announce-fda-approval-aimovigtm-erenumab-novel-treatment-developed-specifically-migraine-prevention">https://www.novartis.com/news/media-releases/novartis-and-amgen-announce-fda-approval-aimovigtm-erenumab-novel-treatment-developed-specifically-migraine-prevention</a><br /><br />Two other CGRP drugs in the pipeline for launch respectively for midyear and October 2018 are Fremanezumab (Teva) and Galcanezumab (Eli Lilly). You can expect that Novartis is going to aggressively market Aimovig with physicians, pharmacies, wholesalers, PBMs and hospitals to grab as much market share as possible before there is competition. Expect to see Aimovig ads on TV, magazines, give aways to doctors, and coupons for patients.<div class="MsoNormal" style="text-align: justify;">
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<i style="mso-bidi-font-style: normal;"><span style="mso-ascii-font-family: Calibri; mso-bidi-font-family: "Times New Roman"; mso-hansi-font-family: Calibri;">PBIRx has been exclusively providing
intelligent solutions to clients in the management of pharmacy benefit costs
since 1993. With a staff that includes IT personnel, actuaries, financial
analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many
more experts, PBIRx’s mission is to create optimal health care outcomes while
minimizing overall health care costs. For more information, please visit </span></i><a href="http://www.pbirx.com/"><i style="mso-bidi-font-style: normal;"><span style="color: windowtext; mso-ascii-font-family: Calibri; mso-bidi-font-family: "Times New Roman"; mso-hansi-font-family: Calibri; text-decoration: none; text-underline: none;">www.pbirx.com</span></i></a><i style="mso-bidi-font-style: normal;"><span style="mso-ascii-font-family: Calibri; mso-bidi-font-family: "Times New Roman"; mso-hansi-font-family: Calibri;"> or call
(888) 797-2479.</span></i><o:p></o:p></div>
<br />PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com247tag:blogger.com,1999:blog-1653002039921749625.post-42944898328059636282018-04-23T14:15:00.001-04:002018-04-23T14:15:12.512-04:00National Prescription Drug Take-Back Day<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj8ESVSrcTcdR_LYUFoCAoT4QSKmjpwwwUWeRetiN6VwqsvjH2qIV2EpQx_Vt6AfA4B1zSopvXeZ2hV8m15Cjd0xdOLkIOeWsxAptIyt5IIiy_drzQ9G222WWljzmZ_nwDMx5rAxCMf5vyW/s1600/april28.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="252" data-original-width="376" height="214" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj8ESVSrcTcdR_LYUFoCAoT4QSKmjpwwwUWeRetiN6VwqsvjH2qIV2EpQx_Vt6AfA4B1zSopvXeZ2hV8m15Cjd0xdOLkIOeWsxAptIyt5IIiy_drzQ9G222WWljzmZ_nwDMx5rAxCMf5vyW/s320/april28.jpg" width="320" /></a></div>
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<span style="font-family: "Arial",sans-serif;">The Drug Enforcement Administrative
(DEA) has announced another opportunity for consumers to dispose of unneeded
and expired prescription drugs during the DEA National Prescription Drug
Take-Back Day, which will be held <b style="mso-bidi-font-weight: normal;">Saturday,
April 28, 2018</b>. On this day, from 10 AM to 2 PM, thousands of
temporary collection sites will be available across the country to accept
unneeded prescription drugs, including controlled substances, for safe and
legal disposal. To date, DEA’s Take-Back Day initiative has collected a
combined total of more than 900,000 pounds of unneeded medications, helping to
prevent diversion, misuse, and abuse of the drugs. Follow this link to
find the site in your area for drug disposal. <o:p></o:p></span></div>
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<a href="https://www.deadiversion.usdoj.gov/drug_disposal/takeback/" target="_blank"><span style="color: #0070c0; font-family: "Arial",sans-serif;">https://www.deadiversion.usdoj.gov/drug_disposal/takeback/</span></a><span style="color: #0070c0; font-family: "Arial",sans-serif;"> <span style="mso-spacerun: yes;"> </span> <o:p></o:p></span></div>
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<span style="font-family: "Arial",sans-serif;">The National Association of Boards of
Pharmacy (NABP) AWARXE® Prescription Drug Safety Program encourages consumer
participation in DEA Take-Back Day events and provides information about the
importance of safe drug disposal in helping to curb prescription drug abuse
rates. Consumers who are unable to participate in the DEA Take-Back Day can
find locations of permanent drug disposal sites using the AWARxE </span><a href="https://nabp.pharmacy/initiatives/awarxe/drug-disposal-locator/" target="_blank"><span style="color: #0070c0; font-family: "Arial",sans-serif;">Drug
Disposal Locator Tool</span><span style="font-family: "Arial",sans-serif;">.</span></a><span style="font-family: "Arial",sans-serif;"><o:p></o:p></span></div>
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<i style="mso-bidi-font-style: normal;"><span style="color: windowtext; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin;">PBIRx has been
exclusively providing intelligent solutions to clients in the management of
pharmacy benefit costs for 25 years. With a staff that includes IT personnel,
actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA
Compliance Officers and many more experts, PBIRx’s mission is to create optimal
health care outcomes while minimizing overall health care costs. For more
information, please visit </span></i><a href="http://www.pbirx.com/"><i style="mso-bidi-font-style: normal;"><span style="color: windowtext; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; text-decoration: none; text-underline: none;">www.pbirx.com</span></i></a><i style="mso-bidi-font-style: normal;"><span style="color: windowtext; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin;"> or call (888) 797-2479.</span></i><span style="font-family: "Calibri",sans-serif; mso-ascii-theme-font: minor-latin; mso-bidi-font-family: "Times New Roman"; mso-bidi-theme-font: minor-bidi; mso-hansi-theme-font: minor-latin;"><o:p></o:p></span></div>
<br />PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com82tag:blogger.com,1999:blog-1653002039921749625.post-88907843981667859592018-04-17T14:16:00.002-04:002018-04-17T14:17:58.460-04:00Brand Names vs Generics - Is There a Difference?<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi4fr6tkXE9QheDI0x4UXDBjz_ZfHrkk6gkpQZgUK0gEG61VLHM5iUduK6jytFYPkzYpJgnanaL9afI06Z3wfl1gbcG1FSxCpt-2F_WFleI50KKtYM0qwWvRdot-XxGVfSMPQ8Qhsx0I41k/s1600/shutterstock_559764592.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="527" data-original-width="1000" height="168" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi4fr6tkXE9QheDI0x4UXDBjz_ZfHrkk6gkpQZgUK0gEG61VLHM5iUduK6jytFYPkzYpJgnanaL9afI06Z3wfl1gbcG1FSxCpt-2F_WFleI50KKtYM0qwWvRdot-XxGVfSMPQ8Qhsx0I41k/s320/shutterstock_559764592.jpg" width="320" /></a></div>
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The cost difference between a brand name drug and its generic equivalent can be hundreds of dollars. Generic drugs are equal substitutes for their brand name counterparts. The FDA conducts rigorous reviews on all generics to make sure these medications meet the same standards as the brands. <br />
<ul>
<li>A generic medication works in the same way and provides the same clinical benefit as its brand-name version. </li>
<li>Any generic medication modeled after a brand-name medication must perform the same in the body as the brand-name medication. </li>
<li>FDA scientists review the manufacturers’ procedures and FDA inspectors go to the generic drug manufacturer's facility to verify standards </li>
<li>Placebos labeled with a brand name can prompt as much relief for conditions such as headache andheartburn as tablets containing the actual drug </li>
<li>Direct-to-consumer advertising for drugs totals about $5 billion annually </li>
<li>When multiple generic companies market the same product, market competition typically results in prices about 85% less than the brand name. </li>
</ul>
Drug companies must submit an Abbreviated New Drug Application (ANDA) for approval to market a generic drug. An ANDA must show that the generic is equivalent to the brand in the following ways: <br />
<ul>
<li>The active ingredient is the same and the inactive ingredients of the medication are FDA-Approved</li>
<li>Extensive "stability tests" prove that generic versions are effective for, at minimum, the same amount of time as the brand-name, if not longer. </li>
<li>Evidence must be provided that each step of the manufacturing process will produce the same result each time.</li>
</ul>
Plan sponsors typically implement a plan design so that the member has to pay the difference between the brand cost and generic cost, even if the doctor indicates brand on the prescription. However, plan sponsors who do not, are paying significantly higher costs for members who choose the higher cost brand drug. <br />
<br />
<i>PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit <a href="http://www.pbirx.com/">www.pbirx.com</a> or call (888) 797-2479.</i>PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com40tag:blogger.com,1999:blog-1653002039921749625.post-88723694011324058952018-04-02T12:59:00.001-04:002018-04-02T13:02:02.274-04:00Update on HIV drugs<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgL8UFmRlkpb09BHjDPDaBRYZ66AXBGe3BFynRgkCHTEubINLrzeeFnG8ATY5tqLnOG9pbtBkyFpx-wqc3LN28aCXdsMGzxYQOMsKRs8_S9W3NHuNgRtVKgES0CzwsjeldUq3faI6zyKRiF/s1600/shutterstock_273039770.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="659" data-original-width="1000" height="210" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgL8UFmRlkpb09BHjDPDaBRYZ66AXBGe3BFynRgkCHTEubINLrzeeFnG8ATY5tqLnOG9pbtBkyFpx-wqc3LN28aCXdsMGzxYQOMsKRs8_S9W3NHuNgRtVKgES0CzwsjeldUq3faI6zyKRiF/s320/shutterstock_273039770.jpg" width="320" /></a></div>
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<span style="color: black; font-family: "arial" , sans-serif; font-size: 10.5pt;">Up to 25,000 Americans with HIV are currently multidrug resistant,
of which 12,000 are in urgent need of a new treatment option because their
current treatment regimen is failing them.<o:p></o:p></span></div>
<div style="background: white; line-height: 18.0pt; margin-bottom: 9.6pt; margin-left: 0in; margin-right: 0in; margin-top: 4.8pt;">
<span style="background: white; color: black; font-family: "arial" , sans-serif; font-size: 10.5pt;">On February 7,
2018, Gilead pharmaceuticals introduced Biktarvy, a new 3-drug combination
tablet. It is approved as a complete regimen for initial treatment in patients
with no treatment history. The cost is approximately $36,000 per year. On the
same day, Mylan introduced Symfi Lo, which is a new product; but it contains 3
older drugs; efavirenz (Sustiva), tenofovir disoproxil (Viread), and lamivudine
(Epivir). The annual cost is about $24,000. Symfi, which contains a higher
dosage of efavirenz, will be hitting the market within the coming weeks.<o:p></o:p></span></div>
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<span style="color: black; font-family: "arial" , sans-serif; font-size: 10.5pt;">One month later, on March 8, 2018, TaiMed Biologics introduced
Trogarzo (ibalizumab-uiyk), an intravenous treatment approved to be used in
combination with other antiretrovirals. In contrast to Biktarvy, this is to be
used only in patients who have failed multiple other HIV drugs.<span style="mso-spacerun: yes;"> </span>It is administered intravenously once every
14 days by a trained medical professional and used in combination with other
antiretroviral medications. It carries a hefty price tag of approximately $118,000
per year. <o:p></o:p></span></div>
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<span style="color: black; font-family: "arial" , sans-serif; font-size: 10.5pt;">Though several new generics for
HIV/AIDS are now available, they likely would not create significant
disruptions to the market due to the current preference and ease of use of
combination therapies. Two generic products have been introduced: Mylan
launched a generic version of Bristol-Myers Squibb’s Sustiva (efavirenz), and
Teva Pharmaceutical Industries Ltd. launched a generic version of Gilead
Sciences’ Viread (tenofovir disoproxil fumarate). These two products are mainly
used in combination therapies with other drugs that still have patent
protection. “<span style="background: white;">Switching a patient to take two or
three individual HIV/AIDS drugs instead of a two-or-three-drug combination has
never been successful,</span>” stated Mesfin Tegenu, the President of
PerformRx. <o:p></o:p></span></div>
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<a href="https://aishealth.com/archive/hbd-20180226-ndbn022318-02">https://aishealth.com/archive/hbd-20180226-ndbn022318-02</a><o:p></o:p></div>
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<div class="Normal1">
<i style="mso-bidi-font-style: normal;"><span style="color: windowtext; font-family: "calibri" , sans-serif; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin;">PBIRx has
been exclusively providing intelligent solutions to clients in the management
of pharmacy benefit costs since 1993. With a staff that includes IT personnel,
actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA
Compliance Officers and many more experts, PBIRx’s mission is to create optimal
health care outcomes while minimizing overall health care costs. For more
information, please visit </span></i><a href="http://www.pbirx.com/"><i style="mso-bidi-font-style: normal;"><span style="font-family: "calibri" , sans-serif; text-decoration: none;">www.pbirx.com</span></i></a><i style="mso-bidi-font-style: normal;"><span style="color: windowtext; font-family: "calibri" , sans-serif; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin;"> or call (888) 797-2479.</span></i><o:p></o:p></div>
<br />PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com704tag:blogger.com,1999:blog-1653002039921749625.post-80343284042252699032018-03-27T11:33:00.003-04:002018-03-27T11:35:04.218-04:00Diabetes Alert Day<br />
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<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhQL9OWFjxUuma12dmV1Nw5azGnr4RGYxePqgDc2zZRQMca0euvjOs0LsEB23NTdXa50flsbd90omyDdjUQV6nzB6hB6V3SuNiaGxb7TC2ZO3QVWQ0e_SMa4bPHyOn8HEsVe3trw-4X7lVS/s1600/shutterstock_182417234.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="667" data-original-width="1000" height="213" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhQL9OWFjxUuma12dmV1Nw5azGnr4RGYxePqgDc2zZRQMca0euvjOs0LsEB23NTdXa50flsbd90omyDdjUQV6nzB6hB6V3SuNiaGxb7TC2ZO3QVWQ0e_SMa4bPHyOn8HEsVe3trw-4X7lVS/s320/shutterstock_182417234.jpg" width="320" /></a></div>
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Tuesday, March 27, 2018 has been named American Diabetes
Association Alert Day by the ADA, to sound the alarm about the prevalence of
type 2 diabetes.<span style="mso-spacerun: yes;"> </span>Everyone is encouraged
to take the Type 2 Diabetes Risk Test.<span style="mso-spacerun: yes;">
</span>The test is free, anonymous and takes a minute to complete.<span style="mso-spacerun: yes;"> </span>By answering questions such as “Do you have a
family history of diabetes?” and “Are you physically active?” you can learn if
you are at risk in 60 seconds.<o:p></o:p></div>
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<a href="http://www.diabetes.org/are-you-at-risk/diabetes-risk-test/?loc=alertday">http://www.diabetes.org/are-you-at-risk/diabetes-risk-test/?loc=alertday</a>
<o:p></o:p></div>
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<ul>
<li>·<span style="font-size: 7pt; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;">
</span><span style="text-indent: -0.25in;">Diabetes affects about 30.3 million Americans –
9.4 percent of the US population</span></li>
<li>·<span style="font-size: 7pt; font-stretch: normal; font-variant-east-asian: normal; font-variant-numeric: normal; line-height: normal;">
</span><span style="text-indent: -0.25in;">Nearly 1 in 4 adults with diabetes are unaware
that they have the disease</span></li>
</ul>
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Physical activity can do a lot for your health and it’s
never too late to get active.<span style="mso-spacerun: yes;">
</span>Maintaining a healthy weight can also help to prevent and manage
problems like prediabetes, high blood pressure and high cholesterol.<span style="mso-spacerun: yes;"> </span><o:p></o:p></div>
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One in three Americans is at risk for developing type 2
diabetes that can lead to complications such as kidney disease, blindness and
amputations.<span style="mso-spacerun: yes;"> </span>Type 2 diabetes does not
have to be permanent; it can be prevented or delayed with a healthy
lifestyle.<span style="mso-spacerun: yes;"> </span>You can learn more at <a href="http://www.diabetes.org/">http://www.diabetes.org/</a> .<o:p></o:p></div>
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<br /></div>
<div class="Normal1">
<i style="mso-bidi-font-style: normal;"><span style="color: windowtext; font-family: "calibri" , sans-serif; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin;">PBIRx has
been exclusively providing intelligent solutions to clients in the management
of pharmacy benefit costs since 1993. With a staff that includes IT personnel,
actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA
Compliance Officers and many more experts, PBIRx’s mission is to create optimal
health care outcomes while minimizing overall health care costs. For more
information, please visit </span></i><a href="http://www.pbirx.com/"><i style="mso-bidi-font-style: normal;"><span style="font-family: "calibri" , sans-serif; text-decoration: none;">www.pbirx.com</span></i></a><i style="mso-bidi-font-style: normal;"><span style="color: windowtext; font-family: "calibri" , sans-serif; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin;"> or call (888) 797-2479.<o:p></o:p></span></i></div>
<br />PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com6tag:blogger.com,1999:blog-1653002039921749625.post-9939161078336260402018-03-09T12:17:00.000-05:002018-03-09T12:17:15.219-05:00High Cost Gene Therapy<div class="separator" style="clear: both; text-align: center;">
<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhNhIfUWVugwZrwlzU8IdeyiT2mScOioWp6gnAj99mknRf58lh43c2LB1J42P3NAUNOzcJM-YRkKGXgTfFzxBGk-xAgyqqoiT1faekKcN7LA96UWngh3k8QH20JzFq_yzRciIliVjgGtykf/s1600/eye+close+up.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" data-original-height="830" data-original-width="1264" height="262" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhNhIfUWVugwZrwlzU8IdeyiT2mScOioWp6gnAj99mknRf58lh43c2LB1J42P3NAUNOzcJM-YRkKGXgTfFzxBGk-xAgyqqoiT1faekKcN7LA96UWngh3k8QH20JzFq_yzRciIliVjgGtykf/s400/eye+close+up.jpg" width="400" /></a></div>
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<span style="font-family: Calibri;"><span style="font-size: 14.6667px; white-space: pre-wrap;">Is your company prepared for the new changes in the drug industry? There are currently 20 new drugs in the gene therapy pipeline, and Luxturna, approved by the FDA in December 2017, has an estimated price tag of $425,000 per eye, as a one-time treatment.</span></span></div>
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<span style="font-family: Calibri;"><span style="font-size: 14.6667px; white-space: pre-wrap;">Luxturna is a new gene therapy for the treatment of a rare, inherited form of blindness affecting 1,000-2,000 people in the United States. It is administered via subretinal injection by a surgeon experienced in performing intraocular surgery into the eye for biallelic RPE65 mutation-associated retinal dystrophy. Patients should be treated first with a short course of oral prednisone to limit the potential reaction to Luxturna. </span></span></div>
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<span style="font-family: Calibri;"><span style="font-size: 14.6667px; white-space: pre-wrap;">On January 3, 2018, Spark Therapeutics announced three new payer programs: an outcomes-based rebate arrangement with a long-term durability measure; an innovative contracting model that aims to reduce risk and financial burden for payers and treatment centers; and a proposal to CMS under which payments for Luxturna would be made over time. “We believe that access to therapy is a shared responsibility among Spark Therapeutics, payers, health benefit providers, physicians and treatment centers.” </span></span></div>
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<span style="font-family: Calibri;"><span style="font-size: 14.6667px; white-space: pre-wrap;">Luxturna was originally intended to only be administered at approved Ocular Gene Therapy Treatment Centers, which have retinal specialists, nurses and genetic counselors with experience treating patients with inherited retinal diseases. “Spark Therapeutics is working with affiliates of Express Scripts to enable the innovative contracting model by leveraging their specialty distribution and specialty pharmacy capabilities” and they are in active discussions with other national and regional payers to enter into similar agreements allowing them to purchase Luxturna, rather than the treatment centers. “Luxturna and other potential one-time therapies face unique health insurance challenges given current practices and regulations in the U.S. healthcare system.” </span></span></div>
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<span style="font-family: Calibri;"><span style="font-size: 14.6667px; white-space: pre-wrap;">For the outcomes-based pricing, Spark Therapeutics has an agreement with Harvard Pilgrim to pay rebates if patient outcomes fail to meet a specified threshold, thereby linking the payment for Luxturna to both short-term efficacy (30-90 days) and longer-term durability (30 months). These measures are unique to this one-time gene therapy. </span></span></div>
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<span style="font-family: Calibri;"><span style="font-size: 14.6667px; white-space: pre-wrap;">Luxturna might only be the start of a whole new way that insurance companies pay for medications in the United States. Be sure to talk to your PBM or medical company and consultants now so that you can be proactive in your approach to implement recommended prior authorization and coverage of these high priced gene therapies.</span></span></div>
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<span style="font-family: Calibri;"><span style="font-size: 14.6667px; white-space: pre-wrap;"><a href="http://ir.sparktx.com/news-releases/news-release-details/spark-therapeutics-announces-first-their-kind-programs-improve">http://ir.sparktx.com/news-releases/news-release-details/spark-therapeutics-announces-first-their-kind-programs-improve</a></span></span></div>
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<span style="font-family: Calibri;"><span style="font-size: 14.6667px; white-space: pre-wrap;"><i>PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.</i></span></span></div>
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PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com2tag:blogger.com,1999:blog-1653002039921749625.post-30206879699212170752018-02-27T16:27:00.002-05:002018-02-27T16:31:35.297-05:00Tamiflu Update<div class="separator" style="clear: both; text-align: center;">
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Prescriptions for Tamiflu have seen more than a 5-fold increase this flu season, compared to last year, according to GoodRx. “It appears to be the worst flu epidemic in years”. Parts of the Midwest are seeing a 10-fold increase. (Fortunately, a handful of states are not seeing widespread flu.) A shortage of the medication is a result of the high volume of prescriptions written for Tamiflu this year.
Despite the surge of prescriptions, there are some doubts about whether Tamiflu is even effective for treatment or prevention. According to a study-of-studies, or meta-analysis performed by Cochrane Research, Tamiflu may provide a much smaller benefit than expected. At best, the analysis found that Tamiflu may only help patients recover one day faster, and may not reduce the number of flu-related complications, like pneumonia. Additionally, it may only reduce the risk of getting sick by 55%. At about $100 per prescription, for some, the benefits may not outweigh the cost.
For an interactive map that shows the flu cases in each state, week-by-week, click here: <a href="https://gis.cdc.gov/grasp/fluview/main.html" target="_blank">https://gis.cdc.gov/grasp/fluview/main.html</a><br />
<br />
<a href="https://www.beckershospitalreview.com/supply-chain/tamiflu-prescriptions-up-640-from-last-year-3-things-to-know.html">https://www.beckershospitalreview.com/supply-chain/tamiflu-prescriptions-up-640-from-last-year-3-things-to-know.html</a><br />
<br />
<a href="https://www.goodrx.com/blog/tamiflu-prescriptions-reveal-shocking-flu-trend/">https://www.goodrx.com/blog/tamiflu-prescriptions-reveal-shocking-flu-trend/</a><br />
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<i>PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.
</i>PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com3tag:blogger.com,1999:blog-1653002039921749625.post-8470308206253288272018-02-22T16:30:00.001-05:002018-02-22T16:31:11.394-05:00Albertsons to Purchase Rite Aid<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjX13560cJl2O2qvtJXbv4wlcnzfJzA2z2FZddjnj8vJyyzqkuQWZG2F1NeauDmTU4wXhPOFoV7K5-eOuT_NBYY8wF7KVOuGJgT1xhnCNrnoKpP9fFPIjGPNfWKaggVeXFIVyhunjZFFjjj/s1600/Albertsonslogo.png" imageanchor="1" style="clear: right; float: right; margin-bottom: 1em; margin-left: 1em;"><img border="0" data-original-height="225" data-original-width="225" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjX13560cJl2O2qvtJXbv4wlcnzfJzA2z2FZddjnj8vJyyzqkuQWZG2F1NeauDmTU4wXhPOFoV7K5-eOuT_NBYY8wF7KVOuGJgT1xhnCNrnoKpP9fFPIjGPNfWKaggVeXFIVyhunjZFFjjj/s200/Albertsonslogo.png" width="200" /></a>Albertsons, a grocery chain with over 2500 stores in 37 states, announced on February 20, 2018 that it plans to acquire the remainder of the Rite Aid stores, the third-largest pharmacy chain. It will be acquiring those stores that were not part of the Walgreens purchase in January. This combined company will have about 4,900 locations, 4,350 pharmacy counters and 320 clinics across the U.S. The merger is set to close in the second half of the year. Most of Albertsons’ pharmacies will be rebranded as Rite Aid. The deal is aimed at competing with retail giant Amazon, which is eyeing its own entry into healthcare, as well as Walmart and CVS.<br />
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This is a win for both companies: Rite Aid will get a buyer for the remainder of their stores; Albertsons will add new locations and size under growing pressure from online competitors. The two companies have a combined value of around $24B, including debt, according to the Wall Street Journal.<br />
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Walgreens expects to close the acquisition of nearly half of its rival’s stores in the spring. When this merger is complete, Walgreens will own about the same number of stores as archival CVS Health (9600).<br />
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Walgreens is also said to be in early-stage talks to acquire AmerisourceBergen, a drug wholesale company.
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<a href="https://www.cnbc.com/2018/02/20/albertsons-to-acquire-rite-aid-in-defense-move-against-amazon.html" target="_blank">https://www.cnbc.com/2018/02/20/albertsons-to-acquire-rite-aid-in-defense-move-against-amazon.html </a><br />
<br />
<a href="https://www.usatoday.com/story/money/2018/02/20/albertsons-and-rite-aid-plan-merger-creates-u-s-supermarket-and-healthcare-giant/353958002/" target="_blank">https://www.usatoday.com/story/money/2018/02/20/albertsons-and-rite-aid-plan-merger-creates-u-s-supermarket-and-healthcare-giant/353958002/ </a><br />
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<i>PBIRx has been exclusively providing intelligent solutions to clients in the management of pharmacy benefit costs since 1993. With a staff that includes IT personnel, actuaries, financial analysts, clinical pharmacists, attorneys, HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create optimal health care outcomes while minimizing overall health care costs. For more information, please visit www.pbirx.com or call (888) 797-2479.
</i>PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com2tag:blogger.com,1999:blog-1653002039921749625.post-87581118851382015022018-02-16T20:02:00.001-05:002018-02-16T20:02:18.665-05:00New US Secretary of Health & Human Services<br />
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<span style="color: windowtext; font-family: "Calibri",sans-serif;">Alex
Azar was confirmed as the US Secretary of Health & Human Services on
January 24, 2018. He served as the Deputy Secretary of Health & Human
Services from 2005-2007, under President George W. Bush<o:p></o:p></span></div>
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<span style="color: windowtext; font-family: "Calibri",sans-serif;">In
between these 2 appointments (2012-2017) Azar was president of the US division
of Eli Lilly, one of the largest American pharmaceutical companies, which is
based in Indiana, Mike Pence’s home state. He was responsible for the
entire company’s operations. Prices under Azar rose dramatically; for
example, Humalog’s price doubled in just those 5 years. His new position
bodes well for the pharmaceutical industry; it seems unlikely that Azar will
push his former industry to lower prices. <o:p></o:p></span></div>
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<span style="color: windowtext; font-family: "Calibri",sans-serif;">However,
if Azar does go after drug prices, he </span><a href="https://twitter.com/ArmstrongDrew/status/930093362811719680" target="_blank"><span style="color: windowtext; font-family: "Calibri",sans-serif; text-decoration: none; text-underline: none;">may focus</span></a><span style="color: windowtext; font-family: "Calibri",sans-serif;"> on pharmacy
benefit managers; Big Pharma likes to </span><a href="https://www.bloomberg.com/gadfly/articles/2017-03-20/eli-lilly-our-drug-price-hikes-don-t-work" target="_blank"><span style="color: windowtext; font-family: "Calibri",sans-serif; text-decoration: none; text-underline: none;">blame PBMs for rising costs</span></a><span style="color: windowtext; font-family: "Calibri",sans-serif;">. At a minimum,
insurers and pharmaceutical companies may soon get an experienced secretary
familiar with how the HHS works. <o:p></o:p></span></div>
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<span style="color: windowtext; font-family: "Calibri",sans-serif;">Rollcall.com
has reported that since 2000, Azar spent about $105,000 in political
contributions.<o:p></o:p></span></div>
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<a href="https://www.bloomberg.com/gadfly/articles/2017-11-13/hhs-secretary-nominee-alex-azar-a-friend-to-health-care-firms"><span style="font-family: "Calibri",sans-serif;">https://www.bloomberg.com/gadfly/articles/2017-11-13/hhs-secretary-nominee-alex-azar-a-friend-to-health-care-firms</span></a><span style="color: windowtext; font-family: "Calibri",sans-serif;"><o:p></o:p></span></div>
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<a href="https://www.fiercehealthcare.com/healthcare/10-things-to-know-about-trump-s-hhs-sec-nominee-alex-azar"><span style="font-family: "Calibri",sans-serif;">https://www.fiercehealthcare.com/healthcare/10-things-to-know-about-trump-s-hhs-sec-nominee-alex-azar</span></a><span style="color: windowtext; font-family: "Calibri",sans-serif;"><o:p></o:p></span></div>
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<a href="https://www.fiercehealthcare.com/healthcare/10-things-to-know-about-trump-s-hhs-sec-nominee-alex-azar"><span style="font-family: "Calibri",sans-serif;">https://www.fiercehealthcare.com/healthcare/10-things-to-know-about-trump-s-hhs-sec-nominee-alex-azar</span></a><span style="color: windowtext; font-family: "Calibri",sans-serif;"><o:p></o:p></span></div>
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<i><span style="color: windowtext; font-family: "Calibri",sans-serif;">PBIRx
has been exclusively providing intelligent solutions to clients in the
management of pharmacy benefit costs since 1993. With a staff that includes IT
personnel, actuaries, financial analysts, clinical pharmacists, attorneys,
HIPAA Compliance Officers and many more experts, PBIRx’s mission is to create
optimal health care outcomes while minimizing overall health care costs. For
more information, please visit </span></i><a href="http://www.pbirx.com/"><i><span style="color: windowtext; font-family: "Calibri",sans-serif; text-decoration: none; text-underline: none;">www.pbirx.com</span></i></a><i><span style="color: windowtext; font-family: "Calibri",sans-serif;"> or call (888) 797-2479.<o:p></o:p></span></i></div>
<br />PBIRx Socialhttp://www.blogger.com/profile/06882452369630651695noreply@blogger.com1