Vitrakvi Drug - $32,000 per Month

On November 26, 2018, the FDA granted accelerated approval for Vitrakvi (larotrectinib), the first-ever neurotrophic receptor tyrosine kinase inhibitor. 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. 

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. 

"(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.”

The full indication for Vitrakvi is intricate. It is to be used for the treatment of adult and pediatric patients with solid tumors that:

•          have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion
•          are without a known acquired resistance mutation
•         are metastatic

Or

•          where surgical resection is likely to result in severe morbidity
•          have no satisfactory alternative treatments

Or

•         have progressed following treatment.

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.

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.

One reason the drug is so expensive is because this condition is very rare.  Bayer estimates only 2,500 to 3,000 patients in the U.S. develop cancer due to a TRK fusion each year. 

For more information: 

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.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm626710.htm

https://www.forbes.com/sites/matthewherper/2018/11/26/loxo-and-bayers-amazing-drug-has-an-expensive-price/#770ebfb624d0 

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 www.pbirx.com or call (888) 797-2479.

Flu Season 2018-2019

Flu Season 2018-2019

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.

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.

There are different types of vaccines available:

•      Trivalent (3 strain) variety:

•      Standard 3 strain shot (for ages 18-64)

•      High-dose 3 strain shot (for ages 65 and older)

•      Recombinant egg-free 3 strain shot (for ages 18 and older and pregnant women)

•      Quadvalent (4 strain) variety

•      Intradermal (under the skin) version

•      Standard 4 strain shot (for ages 4 and older)

•      Recombinant 4 strain shot (for ages 18 and older and pregnant women

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. 

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.  About 75 percent of the past seasons saw a peak of influenza occur in January or later, sometimes even as late as February.

It is important to take preventive actions to stop the spread of germs during the flu season.  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.

https://www.cdc.gov/flu/index.htm

https://www.cdc.gov/mmwr/volumes/67/rr/rr6703a1.htm?s_cid=rr6703a1_w

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.

To Promote Lower Cost Drugs Including High Cost Specialty Meds, FDA Publishes Two New Draft Guidances

On June 1^st, 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.   Some of these obstacles are related to the current Risk Evaluation and Mitigation Strategies (REMS) 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.

Currently the FDA requires certain 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. 

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. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609045.pdf 

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.  

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.   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.     https://www.bloomberg.com/news/features/2017-12-20/the-loopholes-drug-companies-use-to-keep-prices-high    

https://khn.org/news/drugmakers-blamed-for-blocking-generics-have-milked-prices-and-cost-u-s-billions/ 

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.  This causes delays in the approval of the generic or biologic.   Brand manufacturers have used this litigation to their advantage delaying market entry.

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) "Development of a Shared System REMS Guidance for Industry" and 2) "Waivers of the Single, Shared System REMS Requirement Guidance for Industry".  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 an industry working group (IWG) or third party to expedite negotiations and develop a shared REMS Guidance and ETASU.    The second "draft guidance" allows the generic manufacturer an option to seek a waiver to obtain a separate and comparable REMS policy with ETASU in certain situations where the Brand manufacturer is not cooperating.   https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609048.pdf 

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 lower cost generics and biosimilars to come to market earlier.  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.  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.

 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.  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, which has language excluding biosimilars from rebates.

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.

Aimovig® - The First In A New Class of Drugs to Prevent Migraines

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.

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.

The Pharmacy Times states that “Migraine headache is a painful 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."
https://www.pharmacytimes.com/contributor/ryan-chandanais-ms-cpht/2018/01/migraine-headache-a-look-at-current-treatments-and-the-pipeline

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.

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. https://www.novartis.com/news/media-releases/novartis-and-amgen-announce-fda-approval-aimovigtm-erenumab-novel-treatment-developed-specifically-migraine-prevention

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.

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.

National Prescription Drug Take-Back Day

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 Saturday, April 28, 2018. 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. 

https://www.deadiversion.usdoj.gov/drug_disposal/takeback/    

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 Drug Disposal Locator Tool.

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 www.pbirx.com or call (888) 797-2479.

Brand Names vs Generics - Is There a Difference?

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.

• A generic medication works in the same way and provides the same clinical benefit as its brand-name version. 
• Any generic medication modeled after a brand-name medication must perform the same in the body as the brand-name medication. 
• FDA scientists review the manufacturers’ procedures and FDA inspectors go to the generic drug manufacturer's facility to verify standards 
• Placebos labeled with a brand name can prompt as much relief for conditions such as headache andheartburn as tablets containing the actual drug 
• Direct-to-consumer advertising for drugs totals about $5 billion annually 
• When multiple generic companies market the same product, market competition typically results in prices about 85% less than the brand name. 

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:

• The active ingredient is the same and the inactive ingredients of the medication are FDA-Approved
• Extensive "stability tests" prove that generic versions are effective for, at minimum, the same amount of time as the brand-name, if not longer. 
• Evidence must be provided that each step of the manufacturing process will produce the same result each time.

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.

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.

Update on HIV drugs

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.

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.

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.  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.

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. “Switching a patient to take two or three individual HIV/AIDS drugs instead of a two-or-three-drug combination has never been successful,” stated Mesfin Tegenu, the President of PerformRx.

https://aishealth.com/archive/hbd-20180226-ndbn022318-02

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.

Diabetes Alert Day

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.  Everyone is encouraged to take the Type 2 Diabetes Risk Test.  The test is free, anonymous and takes a minute to complete.  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.

http://www.diabetes.org/are-you-at-risk/diabetes-risk-test/?loc=alertday

• ·         Diabetes affects about 30.3 million Americans – 9.4 percent of the US population
• ·         Nearly 1 in 4 adults with diabetes are unaware that they have the disease

Physical activity can do a lot for your health and it’s never too late to get active.  Maintaining a healthy weight can also help to prevent and manage problems like prediabetes, high blood pressure and high cholesterol. 

One in three Americans is at risk for developing type 2 diabetes that can lead to complications such as kidney disease, blindness and amputations.  Type 2 diabetes does not have to be permanent; it can be prevented or delayed with a healthy lifestyle.  You can learn more at http://www.diabetes.org/ .

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.

High Cost Gene Therapy

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.

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. 

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.”  

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.”  

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. 

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.

http://ir.sparktx.com/news-releases/news-release-details/spark-therapeutics-announces-first-their-kind-programs-improve

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.

Tamiflu Update

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: https://gis.cdc.gov/grasp/fluview/main.html

https://www.beckershospitalreview.com/supply-chain/tamiflu-prescriptions-up-640-from-last-year-3-things-to-know.html

https://www.goodrx.com/blog/tamiflu-prescriptions-reveal-shocking-flu-trend/

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.

Albertsons to Purchase Rite Aid

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.

 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.

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).

Walgreens is also said to be in early-stage talks to acquire AmerisourceBergen, a drug wholesale company.

https://www.cnbc.com/2018/02/20/albertsons-to-acquire-rite-aid-in-defense-move-against-amazon.html 

https://www.usatoday.com/story/money/2018/02/20/albertsons-and-rite-aid-plan-merger-creates-u-s-supermarket-and-healthcare-giant/353958002/ 

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.

New US Secretary of Health & Human Services

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

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.

However, if Azar does go after drug prices, he may focus on pharmacy benefit managers; Big Pharma likes to blame PBMs for rising costs.  At a minimum, insurers and pharmaceutical companies may soon get an experienced secretary familiar with how the HHS works. 

Rollcall.com has reported that since 2000, Azar spent about $105,000 in political contributions.

https://www.bloomberg.com/gadfly/articles/2017-11-13/hhs-secretary-nominee-alex-azar-a-friend-to-health-care-firms

https://www.fiercehealthcare.com/healthcare/10-things-to-know-about-trump-s-hhs-sec-nominee-alex-azar

https://www.fiercehealthcare.com/healthcare/10-things-to-know-about-trump-s-hhs-sec-nominee-alex-azar

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.

Unapproved Opioid Cessation Products

On January 11, the FDA, as well as the Federal Trade Commission, posted joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal.

This marketing can pose a serious health risk, as these products have not been demonstrated to be both safe and effective. Selling these products is a violation of the Federal Food, Drug, and Cosmetic Act.

Reducing the number of Americans who are addicted to opioids has become a huge priority as there are currently 2 million people with an opioid use disorder. “Using products with unsubstantiated claims may prevent those addicted to opioids from seeking approved treatments that have been demonstrated to be safe and effective, delay their path to recovery, and put them at greater risk of death.”

The 11 companies who received warning letters are: Opiate Freedom Center (“Opiate Freedom 5-Pack”), U4Life, LLC (“Mitadone”), CalmSupport, LLC (“CalmSupport”), TaperAid (“TaperAid” & “TaperAid Complete”), Medicus Holistic Alternatives LLC (“Natracet”), NutraCore Health Products, LLC (“Opiate Detox Pro”), Healthy Healing, LLC (“Withdrawal Support”), Soothedrawal, Inc. (“Soothedrawal”), Choice Detox Center, Inc. (“Nofeel”), GUNA, Inc. (“GUNA-ADDICT 1”), and King Bio, Inc. (“AddictaPlex”).

The FDA and FTC have requested responses from each of the companies within 15 working days.

Read the FDA's official statement here.

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.

Avoid the Flu – Get Vaccinated

For the week of December 16, 2017, 23 states, including Connecticut, reported widespread flu activity. About 4% of all doctor visits were for influenza-like illness, as compared with 3% the week before. The national baseline is 2.2%. Nine children have died due to the flu this season alone.

Per the CDC website: “Seasonal flu viruses can be detected year-round; however, seasonal flu activity often begins as early as October and November and can continue to occur as late as May. Flu activity most commonly peaks in the United States between December and February.”

The CDC estimates that flu has resulted in between 9 and 36 million illnesses each year in the United States, and up to 700,000 hospitalizations. The number of flu deaths is not accurately reported, since not everyone is tested and influenza deaths are often the result of complications secondary to another medical problem. However, their mathematical estimate is as high as 56,000 people annually.

Despite the CDC’s recommendation that everyone over the age of 6 months should receive a flu vaccine, only about 50% of Americans do so. This is due to misconceptions around it, including its safety and the belief that the vaccine can give one the flu, which is incorrect. (The vaccines contain an inactivated virus, meaning the viruses are no longer infectious, or a particle designed to look like a flu virus to your immune system.)

https://www.beckershospitalreview.com/quality/flu-season-heats-up-as-23-states-report-widespread-influenza-activity-5-things-to-know.html 

https://www.cdc.gov/flu/about/season/flu-season-2017-2018.htm

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