For the 3.6 million people in the US with severe allergies to food or bee-stings, having a prescription EpiPen on hand can be a matter of life or death.
The anaphylactic shock caused by these allergic reactions can cause hives, swelling, and fatal airway restriction within minutes. EpiPens deliver a precise dose of the hormone epinephrine (perhaps better known as adrenaline) to the thigh muscle, which causes blood vessels to constrict and opens up airways to alleviate these symptoms—or at least slow them down until patients can reach an emergency department. These kinds of allergic reactions lead to about 200,000 emergency hospital visits per year in the US.
The price of these devices has increased 450% within the past nine years, as STAT first reported this past July. On Monday (August 22), Congress began to get involved: Senator Chuck Grassley (R-Iowa) and Senator Richard Blumenthal (D-Conn.) each wrote (pdfs) letters to Mylan, the company that makes EpiPens, to ask about pricing data, requesting information about how costs are determined and alternative payment options for patients. In addition, Senator Amy Klobuchar (D-Minn.) requested that the US Federal Trade Commission and the Senate Judiciary Commission inquire about the price increases.
It appears the reason for the massive increases is the lack of competition: those who can’t afford EpiPens even with insurance must choose between generic alternatives or make-shift measures to stop severe allergic reactions, both of which are more difficult to properly administer.
Mylan, headquartered in Canonsburg, Pennsylvania, is the only company that can legally manufacture EpiPens. When Mylan acquired the patented technology from Merck in 2007, EpiPens cost about $57 each. Now, the devices can cost about $300 each with insurance, and can go for over $1,000 if patients have high deductibles, according to STAT. And the actual costs are likely even higher: the National Institute of Allergy and Infectious Diseases recommends (pdf, p. 30) that patients carry two doses at all times in case their reaction occurs in two parts (users should go to the emergency room after administering the first dose either way). They also expire after a year, meaning patients have to incur these costs annually.
There isn’t much competition for the anaphylactic giant. Last October, a device called Auvi-Q was discontinued after reports that it failed to deliver consistent amounts of epinephrine. There is a cheaper alternative available called Adrenaclick, which costs $142 for two pens with a coupon at Walmart and Sam’s Club, according to Consumer Reports, but is administered slightly differently than EpiPens. EpiPens require a simple cap removal, whereas Adrenaclick has two caps that must be removed. Barbara Young, a pharmacist from the American Society of Health-System Pharmacists, recommends that patients seek training before administering Adrenaclick. EpiPens also require some training, but are simple enough that a child can generally learn to use it on their own, according to Consumer Reports.
Other alternatives to buying EpiPens, like using syringes to self-administer the drug or carrying expired pens, are risky. One mother told STAT that her older son carries expired EpiPens, and she has obtained syringes from her doctor’s office and vials of adrenaline for about $20. These vials expire after three months, though, and injecting adrenaline into a vein accidentally can be fatal. “Anyone using this approach would require extensive medical training to do it effectively and safely” James Baker, Jr., the CEO and chief medical officer of Food Allergy Research & Education told STAT.
Mylan appears to be reaping the benefits of their accidental monopoly. EpiPens now bring in over $1 billion in revenue for the company each year and are responsible for 40% of Mylar’s profits, according to Bloomberg. (Even Martin Shkreli, the former CEO of Turing Pharmaceuticals who became infamous after raising the price of an HIV-malaria drug by 5,000% last year, referred to Mylar as “vultures.”)
Mylan provides EpiPens to uninsured patients in need—but that program doesn’t help patients who have insurance with high deductibles, or those who can’t afford the insurance-subsidized $300 a piece price. Mylan responded to the recent criticism in a statement published on their website, stating that theycompany “has worked tirelessly over the past several years advocating for increased anaphylaxis awareness, preparedness and access to treatment for those living with potentially life-threatening (severe) allergies. Ensuring access to epinephrine—the only first-line treatment for anaphylaxis—is a core part of our mission.”