August 25, 2016 Update:

Mylan announced today that it is taking action to reduce the patient's cost for an epinephrine auto-injector, expanding its copay program so that an individual can receive as much as $300 toward each two-pack (up to a total of six two-packs), doubling the income eligibility for its patient assistance program and opening a pathway so that patients can purchase directly from the company.

This is an important first step. FARE remains committed to working with all parties involved toward lasting solutions that will improve access and affordability to epinephrine, a lifesaving drug.

FARE Statement on Epinephrine Access and Price

08/24/2016

For the millions of Americans at risk for anaphylaxis, epinephrine is a lifeline. It is the only drug that can counteract a potentially life-threatening allergic reaction. FARE believes no individual in need of epinephrine should ever be without this life-saving drug due to a lack of affordable access to the drug. Even a single life lost due to lack of access to this drug is one life too many. We are deeply concerned about the challenges our community face related to the accessibility and affordability of epinephrine, which have become increasingly difficult for various reasons.

  • While the recent expansion of Medicaid coverage in many states has meant an increase in the number of patients with coverage for epinephrine, due to the significantly increased use of high-deductible insurance plans, a growing number of families are faced with exponentially higher personal costs for epinephrine.
  • The Auvi-Q® epinephrine auto injector was withdrawn from the market in the fourth quarter of 2015, markedly limiting product choice for consumers, insurers and their physicians. The impact of this action followed historical trends where limitations on available drug options have led to significant price increases.
  • Two manufacturers (Teva and Adamis) recently applied to the FDA for approval to market epinephrine injectors in the US. Both applications were rejected, further extending the expected time period of limited choice in epinephrine.
  • The "back to school" season is a traditional time during which families purchase new epinephrine supplies, so many individuals are just becoming aware of the higher personal cost for this drug.

FARE cannot control, change or set the price of epinephrine. Within our country’s complex health insurance infrastructure, the amount paid by a patient for any given drug is determined by a number of entities involved in getting a drug to the marketplace, including manufacturers, insurers, regulators, pharmacy benefit managers and pharmacies.

FARE strongly believes that all these entities need to justify the increased cost of epinephrine to consumers and identify solutions that will help to ease the financial burden currently faced by patients who need epinephrine. FARE’s role is to represent the voice of the patient in this process, and where possible help facilitate the dialogue and process by which solutions can be identified and implemented. We cannot accept the status quo.  

Over the past year, FARE has been taking steps to try and ensure all individuals with food allergies have access to epinephrine. These include the following:

  • Met with pharmaceutical companies marketing epinephrine in December 2015 and offered to set up an access plan for individuals with inadequate insurance coverage.
  • Encouraged four different foreign manufacturers to bring their epinephrine products to the U.S.
  • Offered to support manufacturers’ epinephrine applications to the FDA and provide data documenting the critical need for this drug.
  • Offered support for a re-launch of the Auvi-Q®.
  • Conducted multiple studies beginning early in 2016 among its constituent base documenting the patient perspective on access and affordability of epinephrine including the impact that challenges in these areas have on quality of life.
  • Funded and is the lead sponsor of a forthcoming report from the National Academies of Science, Engineering and Medicine (formerly the Institutes of Medicine) that is intended to highlight the growing societal issue of food allergy in America. With an expected publication date of November 2016, data from this report should further support the need to identify immediate solutions to address many issues faced by the food allergy community, including those posted by limitations on access and affordability of epinephrine.

These efforts are part of FARE’s ongoing comprehensive strategy to address this serious issue across a number of fronts. Our goal is to identify meaningful solutions to help ease the current financial burden on patients and to help bring more choices to marketplace. In our role representing the voice of the patient in this process, we hope to use examples from real families that bring the data to life, make the challenges more clear and understandable to all, and to facilitate the dialogue and process by which solutions can be identified and implemented. If this issue has impacted you, we would like to hear your story. Please click here to share it.

Recent News Coverage

EpiPen Maker Lobbies to Shift High Cost to Others (The New York Times, Sept. 16, 2016)
Mylan to Lower EpiPen Costs for Some Patients (The New York Times, Aug. 25, 2016)
Food Allergy Organization Wants EpiPen Access Program (Fox Business, Aug. 24, 2016)
EpiPen Price Rise Hurting Parents Getting Ready for School Year, Experts Say (ABCNews.com, Aug. 22, 2016)
High Price of EpiPens Spurs Consumers, EMTs to Resort to Syringes for Allergic Reactions (Stat News, July 6, 2016)
Lack of Competition Leads to EpiPen Pricing Woes (Modern Healthcare, March 28, 2016)

Current Patient Assistance Resources

FARE advises patients to be aware of the following methods of assistance if they are having trouble filling a prescription for epinephrine due to cost:

    • Explore Patient Assistance Programs.
    • Know your epinephrine options, including EpiPen® and the epinephrine injection auto-injector (Adrenaclick® generic).
    • Take advantage of manufacturer coupons, available for both EpiPen® and the Adrenaclick® generic, where available. Utilize websites such as GoodRx.com to compare pricing and find coupons.
    • If you have a children’s hospital nearby, find out what support or grants it may provide to help you pay for the prescription.
    • Talk to your employer and insurance company about exploring other health insurance plan options and potential cost saving measures.
    • Shop around - check pricing with different pharmacies in your area.
    • When an insurer does not provide affordable access to epinephrine — either by refusing to cover the medication or only covering a small amount of the cost — you can initiate an appeals process through your insurance carrier. FARE has sample letters and information about insurance appeals for high epinephrine cost or denial of coverage available on our website.

ABOUT FARE

Food Allergy Research & Education (FARE) works on behalf of the 15 million Americans with food allergies, including all those at risk for life-threatening anaphylaxis. This potentially deadly disease affects 1 in every 13 children in the U.S. – or roughly two in every classroom. FARE’s mission is to improve the quality of life and the health of individuals with food allergies, and to provide them hope through the promise of new treatments. Our work is organized around three core tenets: LIFE – support the ability of individuals with food allergies to live safe, productive lives with the respect of others through our education and advocacy initiatives; HEALTH – enhance the healthcare access of individuals with food allergies to state-of-the-art diagnosis and treatment; and HOPE – encourage and fund research in both industry and academia that promises new therapies to improve the allergic condition. For more information, please visit www.foodallergy.org and find us on Twitter@FoodAllergy, Facebook, YouTube and Pinterest.

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Media Contact
Nancy Gregory
Senior Director of Communications
Direct: 703-563-3066
ngregory@foodallergy.org

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