The EpiPen––an epinephrine autoinjector––has been on the market since 1977. Mylan acquired the device in 2007, when a pen cost patients about $57. Today, patients have to shell out $500 or more to receive a dollar’s worth of the lifesaving drug, according to an article in Forbes.
Mylan’s profits from selling EpiPens reportedly hit $1.2 billion in 2015. That success came at a steep price for patients. Even after insurance kicks in, customers can be out $400 or more for a pack of two pens. Current guidelines call for prescribing two doses in case the first one fails, which Mylan used as an opportunity to stop selling single pens and begin selling only two-packs, according to Forbes.
Patients do have access to a generic version of a calibrated delivery device for epinephrine, the Adrenaclick, Forbes notes. However, the two devices work differently in ways that result in critical errors if users aren’t properly trained. For example, the EpiPen requires the removal of a single cap for use, whereas the Adrenaclick reportedly requires the removal of two caps.
In related news, Bloomberg reports that two senior U.S. senators are looking into Mylan’s price increases for the EpiPen, saying that the company’s practices may have limited competition and access to the treatment.
“The substantial price increase could limit access to a much-needed medication,” Senator Charles Grassley (R-Iowa) wrote to Mylan Chief Executive Officer Heather Bresch in an August 22 letter.
In a separate letter, Senator Amy Klobuchar (D-Minnesota) asked the Federal Trade Commission to look into whether Mylan had done anything to deny competitors access to the market in order to keep raising prices. She pointed to the Adrenaclick device, which she said is less expensive but has only minimal sales.
In October 2015, Sanofi recalled its rival product, the Auvi-Q epinephrine injection, because of reports of device malfunctions and concerns that it wasn’t delivering the correct dose. In February, Teva Pharmaceutical Industries said that the FDA had identified major deficiencies in its application for its own epinephrine injector. Those setbacks have helped Mylan dominate the market, according to Bloomberg.
Sources: Forbes; August 22, 2016; and Bloomberg; August 22, 2016.