After Mylan hiked the price of its anti-allergy shot EpiPen to over $600 per twin pack, and a public outcry ensued last year, the embattled drugmaker quickly rolled out an authorized generic and talked up its enhanced access programs. But it was too little too late, judging from a new report showing just how much ground Mylan has already lost to low-cost EpiPen alternatives.
In February, non-EpiPen treatments for severe allergic reactions grabbed nearly 30% of the total market, according to research from athenaHealth. In fact, prescriptions for EpiPen alternatives have quadrupled since the start of 2017, according to the report, which was tabulated from 60,000 prescriptions of epinephrine auto-injectors written since the beginning of 2016.
Mylan is ceding some of EpiPen’s market share to Kaléo’s Auvi-Q, even though that product was re-launched recently at an eye-popping price of $4,500. Auvi-Q prescriptions accounted for nearly 13% of scripts written for EpiPen alternatives in February, according to athenaHealth. It probably helps that Kaléo—which, like Mylan, is facing pricing scrutiny from federal lawmakers—has a patient-assistance program that results in little to no out-of-pocket costs for consumers.
But Kaléo is far from Mylan’s only worrisome rival. In January, CVS Health announced it would offer its own generic alternative to EpiPen under a deal with Impax, which markets a rival brand, Adrenaclick. The authorized generic will be produced by Impax and sold at CVS for $109.99 per two-pack. That beats the $339.99 price for Mylan’s authorized generic hands-down.
The athenaHealth report confirms the fears of Wall Street analysts who have been predicting a major EpiPen downfall. Bernstein’s Ronny Gal, for example, released a report in January estimating that EpiPen sales would be a paltry $300 million in 2018, down from an estimated $1.1 billion in 2016. Part of the problem, he said, was that at least one major distributor appears to have opted out of Mylan’s authorized generic.
And there may be another low-cost EpiPen alternative on the horizon. Adamis initially got a rejection from the FDA for its Epinephrine Pre-filled Syringe, prompting partner Teva to drop the project. But Adamis resubmitted the drug to the FDA in January, showing it clearly intends to be a player in this market.
As for Mylan, it’s doing its best to downplay the EpiPen backlash and lost sales. On March 1, it announced that fourth-quarter sales grew 31% year-over-year to $3.27 billion. It also hosted its Investor Day event, focusing largely on what it expects will be future revenue drivers. They include generic Advair, which the FDA is set to rule on later this month, and a low-cost version of the wrinkle-reducing blockbuster Botox that Mylan is in the early stages of developing.
Still, some analysts couldn’t ignore the elephant in the room at Investor Day. Mylan didn’t break out EpiPen sales for 2016 or specifically forecast how the product would perform going forward. “We note that Epipen, Mylan’s largest product, was conspicuously absent from the results and outlook,” wrote Wells Fargo analysts in a note to investors that day.