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Friday, June 8, 2018

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


On June 1st, the FDA published two new "draft guidance" documents, which are recommendations for review and comments to address one of the many complex obstacles to timely generic and biologic drug launches.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   After 60 days, the "draft guidance" comments will be evaluated and new policies will be voted on and become effective with the goal to bring lower cost generics and biologics to the market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    


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.


Friday, May 25, 2018

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.

Monday, April 23, 2018

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. 

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.

Tuesday, April 17, 2018

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.

Monday, April 2, 2018

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.

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.

Tuesday, March 27, 2018

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.

  • ·         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.

Friday, March 9, 2018

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.
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.