Did you know that there are two children per kindergarten class with a clinically significant food allergy in America? The astonishing rise of food allergies has been overshadowed by the most recent increase in price of the EpiPen Twin-Pak. As a part of our Tyler & Madden Food Fight, editorial coverage, we had intended to inform parents about the new regulations and safety measures that exist to protect your child from anaphylactic shock. While we will do just that, we also believe our readers deserve an accurate breakdown of the recent news and the knowledge to save money at the pharmacy.
The Price Hike Explained:
In 2007, when Mylan purchased the company that manufactured the EpiPen, an EpiPen twin-pak cost $93.88*. In July 2013, the price increased to $264.50*. By May of 2015 the price had increased by 75% to $461*. The most recent list price is $608 for the EpiPen Twin-Pak. With an average of two price increases per year, EpiPen generates approximately $1 billion in annual sales for Mylan. (*prices according to Elsevier Gold Standard Drug Database)
Unabridged EpiPen Saga Explained:
Mylan’s auto-injector patent is the key to all of this. It’s common practice in the pharmaceutical industry to jack up the price of product when a patent is about to expire. As part of a settlement agreement (Mylan and Pfizer) Teva Pharmaceutical Industries was permitted to begin marketing a generic alternative to the EpiPen this year. However, the FDA rejected the generic EpiPen unexpectedly. Teva will now have to wait until 2017 to refile for approval.
The Mylan EpiPen epinephrine auto-injection product accounts for 95% share of (U.S.) market, giving Mylan the Monopoly. The only other product on the market is Adrenaclick by Impax Laboratories
This week, CEO of Mylan, Heather Bresch is villainized in the media, over the latest price hike. Mylan stocks to drop, down over 10% in this week alone. Sarah Jessica Parker, the spokesperson for EpiPen publically ends all ties with Mylan on Thursday, via Instagram. The backlash results in the company announcing a $300 rebate card, in addition to doubling eligibility for Mylan’s patient assistance program. They are beginning discussions and procedures to offer the EpiPen direct from the company, which could potentially cut middleman costs.
REBATE CONS: Individuals with Government based insurance coverage, such as Medicaid and Obamacare will not be eligible for the rebate card. The discount is currently only for commercial insurance plans.
Epinephrine Regulation News, Laws and Cost-Saving Alternatives:
With no generic version in site for at least another year and practically all competition for the EpiPen out of the U.S. Market, what’s to stop the price increase for this live-saving product? Congress has already begun to make inquisitions on the recent price gouging as well as improve upon previous legislation. The 113th Congress introduced the School Access to Emergency Epinephrine Act (2013-2014) to help make epinephrine auto-injectors available for K-12 schools. In addition to providing grants and incentives, the laws permit Schools to train faculty to administer epinephrine, maintain and store a supply and orchestrate an emergency health plan. Today, 47 of all 50 states have laws in place requiring epinephrine auto-injectors be made available at schools in the event of an anaphylaxis occurrence.
A cost-saving alternative to EpiPen
Adrenaclick, is readily available at most Walmarts and Sam’s Club, retailing for approximately $142 (with coupon) and only slightly more at Walgreens. A generic version of Adrenaclick, “epinephrine injection, USP auto-injector” is also available. There are differences between Adrenaclick and EpiPen which every user should distinguish before having to use. For example Adrenaclick has two caps that need to be removed, while EpiPen has only one cap. As with any emergency medication, it is recommended that the user learn exactly how to administer the Auto-Injector prior to using.
NEW FDA Updates to Epinephrine Auto-Injectors:
The FDA released updates to the labeling of Epinephrine Auto-Injectors to assist patients in properly administering injections and to avoid complications like injury and infection. The major change is the new time requirements to leave the injection in place.
When you inject, hold the the EpiPen firmly in place for 3 seconds. (previously said to hold in place for ten seconds)
Hold the patient’s leg and keep the leg steady while you inject the epinephrine to avoid injury.
The FDA also includes the rare possibility serious infection occurring at the injection site. Symptoms of possible infection include; persistent redness, warmth, swelling, tenderness. Note: These infections are linked to getting epinephrine in the the buttock rather than the outer thigh.