The EpiPen Saga: Vol. II

It was not too long ago that the pharmaceutical behemoth Mylan outraged American healthcare consumers by inflating the price for their already expensive EpiPen (epinephrine auto-injector) to truly obscene levels. The company ignited a fierce outpouring of criticism and questions from social and mainstream media. Congress brought the company’s CEO to Washington for a few rounds of well-publicized grilling about the extraordinary price increases [1]. Mylan even fast-tracked an “authorized generic” of EpiPen that would be half the price of the branded product. The public’s fury died down and we all went back to watching the waning days of the Obama presidency.

We are now almost exactly two years removed from that theatrical government display before the House Oversight and Government Reform Committee and the saga is still not finished. The trouble is that this time no one seems to be noticing the problem. EpiPens are still $700+ a set and the “authorized generic” (manufactured and distributed by Mylan and virtually indistinguishable from their branded counterparts except they sport the more technical epinephrine auto-injector moniker) remain over $300 at retail.

Nothing has changed on that front. What has changed is that we are currently experiencing a global shortage of both branded and generic products. This has been going on most of this year with pharmacies scrambling to secure units if suppliers suddenly have some available or struggling to find alternatives during the stretches no product is available at all. To the best of my knowledge only one other company (Impax) markets a generic epinephrine auto-injector, but it is technically a generic equivalent to a product called Adrenaclick and may not always be substitutable for prescriptions written for Epipen. This generic, while retailing at about $150 (less than half a Mylan generic), is not covered by many, perhaps even most, insurance plans and itself has become unavailable du, I’m sure, to the demand as a replacement for the dominant product. Because Mylan has nurtured a stranglehold on the epinephrine market over the years, it is the prefered product for most commercial, Medicare and Medicaid programs. From a clinical perspective, it is ludicrous that one company should control virtually all share of a particular drug sector as it leaves options severely limited if/when that monopolistic company is unable to meet demand. This is what we have seen over the course of this year.

And all of this has happened with no fanfare, no hastag campaigns, no congressional hearings and no damning anecdotes of families trying to get their kids an important medication. We are entering the first few weeks of school for children all across the country and many of them will simply have to cross their fingers that they don’t encounter an allergen because they will have no backup if anaphylaxis strikes. Yes there are cumbersome syringe and ampule products that could be used, but these are tricky to use under the best of circumstances and hardly suitable for an untrained young person suffering a sudden attack of anaphylaxis. It is also true that there is another branded epinephrine auto-injector on the market called Auvi-Q, but it’s manufacturer (Kaleo) makes Mylan’s price gouging seem amateurish: a two-shot pack retails at about $5800. As of this moment it will be well into the fall before Mylan might get these critically important products back into the market, but rest remember the Mylan mantra: it’s all about “Better health for a better world”™.

 

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