Expecting EpiPen furor, Mylan crafted lobbying effort to shift burden to payers

EpiPen box

Mylan ($MYL) saw EpiPen trouble coming months ago. It started getting word that copays and high deductibles would push the cost of its high-priced epinephrine remedy onto consumers. And the company knew patients would be upset.

So, as the New York Times now reports, the company stepped up its lobbying efforts to move EpiPen onto an official list of preventive care that payers must provide to patients free of charge. It ponied up backing for patient groups pushing the measure. It enlisted doctors to help. And Mylan specifically asked particular groups to help lobby--though some refused because they considered it a conflict of interest.

The latest news follows weeks of controversy, calls for action in Congress, and demands for government investigations, as Mylan scrambled to answer critics by offering new assistance to patients and a hey-presto generic that would cost half what the brand does. And the price of EpiPen, as we all now know, steadily rose after Mylan took over marketing from Merck ($MRK) in 2007--to the point where its list price is now more than four times as expensive as it was in 2009, and more than 10 times the $57 cost when Merck unloaded the brand.

As the storm appeared on the horizon, Mylan was also working on a journal article advocating the reclassification move, with lead author Dr. Leonard Fromer, who’d served as a paid consultant for Mylan in the past. Classifying “epinephrine as a preventive medicine by both the U.S. Preventive Services Task Force and insurers could increase patient access, improve outcomes and save lives,” stated the article, which published online last month.

If EpiPen were reclassified, patients wouldn’t bear the burden of EpiPen’s cost. The parents who’ve shelled out $600 and more for their back-to-school supplies could get their next round for free. That’s the sort of access move that patient advocates like.

But it’s also the sort of move that can help Mylan keep prices high. It was widespread public complaint on social media that touched off the EpiPen pricing outcry, after all. And with EpiPen lacking a head-to-head competitor, payers have limited leverage to force its list price downward. Insurers and other payers would have to pick up the tab, and the costs could then trickle down to consumers and taxpayers through higher premiums and more funding for government programs.

Mylan has provided funding and other support for a range of groups and people pushing lawmakers to make this change, the NYT notes, including a nonprofit coalition formed by the Allergy and Asthma Network specifically for this purpose.

Mylan says its backing for the reclassification has been at arm’s length. It provided financing for the coalition, for instance, but “we were clear in our corporate sponsorship agreements that the coalition would maintain control,” the company told the Times.

And Mylan did pay a consulting firm to assist with Fromer's American Journal of Medicine article, but  Mylan says its ghostwriting services didn’t influence the author's conclusions. 

“Mylan provided third-party support to assist Dr. Fromer with the development process,” the company said in a statement. “[H]owever, following the International Committee of Medical Journal Editors criteria for authorship, all content was his own, not ghost authored.”

But the NYT reports that some groups refused to participate in Mylan’s lobbying because they saw it as a potential conflict of interest. For instance, Mylan offered to pay the American College of Allergy, Asthma and Immunology for a series of papers focused on adding the epinephrine auto-injector to the preventive drug list.

 “As we looked at it, we thought, ‘No way that we could do that,’” executive director Dr. Bobby Quentin Lanier told the paper..

It’s not the first time, of course, that Mylan has lobbied for legislation that would benefit EpiPen sales. One bill that it’s currently backing, as the Times notes, would require epinephrine auto-injectors--of which EpiPen is the only marketed version--on all commercial aircraft.

The NYT piece--and follow-ups like this one--are publishing as Mylan CEO Heather Bresch prepares for an appearance on Capitol Hill Wednesday. Bresch will face questioning by the House Committee on Oversight and Government Reform.

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