The Soaring Price of EpiPen®
By Darrell Hulisz, RPh, PhamD, Associate Professor, CWRU School of Medicine, contributor, & Alison Dailey, Pharmacy Intern, Ohio Northern University, contributor
The EpiPen® is a potential life-saving medication for patients who experience severe allergic reactions. The drug recently and dramatically spiked in price, drawing considerable national attention. The auto-injector formulation manufactured by Mylan, known as EpiPen, contains epinephrine, a first-line treatment for anaphylaxis. The product comes in two formulations: 0.3mg epinephrine dose for adults and 0.15mg epinephrine dose for children (known as EpiPen Jr ®).
When Mylan bought the device from a competitor in 2007, the cost for a set of two auto-injectors was about $94. Today, the cost for an EpiPen kit (pair of two pens) is over $700. This affects many patients with a history of anaphylaxis, as over 3.6 million prescriptions for the EpiPen were written last year and more will continue to be written. This is fueled in part by the short expiration date. The auto-injector formulation is only given a maximum 18-month expiration date from the date of manufacturing.
There are currently two main brands of epinephrine auto-injectors on the market. These include EpiPen and Adrenaclick®. The current cash price for Adrenaclick is over $400 for two auto-injectors. According to the FDA Orange Book which outlines approved drug products with therapeutic equivalence, both products are rated as “BX” which means that the FDA does not consider these products to be therapeutically equivalent to one another due to insufficient evidence.
Additionally, there are differences in the steps of administration between auto-injectors. For example, EpiPen has built-in needle protection and requires one safety cap to be removed prior to use while Adrenaclick does not have built-in needle protection and requires two safety caps to be removed prior to injection. A combination of the BX rating, as well as different instructions for use, means that a therapeutic interchange from one brand to another requires prescriber approval and additional patient training.
EpiPen is stocked as the mandatory product for use in public schools in at least 11 states after Congress passed a law recommending its use. Thus, competitor products are not approved for use in U.S. schools in several states, effectively creating a monopoly and the potential for dramatic price increases. Mylan does offer a voucher card program for eligible patients, resulting in a $300 savings for each EpiPen 2-Pak carton per prescription refill.
One solution to the problem of rising prices would be to produce generic alternatives. Unfortunately, production of generic EpiPen is complicated by the difficulty in replicating the administration technique of the correct dose via the auto-injector system. Mylan has agreed to produce a generic form of the auto-injector, at a projected list price of about $300 for a kit of two pens.
As a result of the dramatic increase in EpiPen prices, many patients and providers are seeking more affordable alternatives. Thus, it is important for clinicians to stay up to date concerning the auto-injectors’ proper use and maintenance in order to educate their patients.
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O’Donnell J., 2016. Family matters: EpiPens had high-level help getting into schools. USA Today. Retrieved from http://www.usatoday.com/story/news/politics/2016/09/20/family-matters-epipens-had-help-getting-schools-manchin-bresch/90435218/
Smith M., 2016. EpiPen price hikes: What to know. Medscape. Retrieved from http://www.medscape.com/viewarticle/867814#vp_2