A point not mentioned by advocates of adding EpiPens to a federal list of preventive medical services is that a big potential beneficiary of the campaign is Mylan, the pharmaceutical giant behind the device.
Against a growing outcry over the surging price of EpiPens, a chorus of prominent voices has emerged with a smart-sounding solution: Add the EpiPen, the lifesaving allergy treatment, to a federal list of preventive medical services, a move that would eliminate the out-of-pocket costs of the product for millions of families — and mute the protests.
Dr. Leonard Fromer, a clinical professor of family medicine at UCLA, just promoted the idea in the prestigious American Journal of Medicine. A few groups are preparing a formal request to the government. And Tonya Winders, who runs a patient-advocacy nonprofit organization, late last month contacted crucial lawmakers on Capitol Hill.
“We can save lives by ensuring access to these medications,” said Winders, chief executive of the Allergy and Asthma Network.
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A point not mentioned by these advocates is that a big potential beneficiary of the campaign is Mylan, the pharmaceutical giant behind EpiPens. The company would be able to continue charging high prices for the product without patients complaining about the cost.
An examination of the campaign by The New York Times, including interviews with more than a dozen people, shows Mylan is aware of that benefit and has been helping orchestrate and pay for the effort.
The journal article says it was “drafted and revised” by a medical-writing consulting firm paid by Mylan, in consultation with Fromer. Fromer has served in the past year as a paid Mylan consultant, something he discloses as part of the journal article. The company has also contributed money to many other groups behind the effort, and it has met with them — and Winders’ organization in particular — to coordinate its strategy, the participants said.
The effort has accelerated in recent weeks, just as Mylan has faced a flood of criticism about its pricing of EpiPens. The retail price for the standard two-pack has jumped nearly fivefold since 2010, hitting $608 this year. Multiple lawmakers and regulators have opened investigations into the pricing of the product, which has virtually no market competition.
The idea being advanced is simple: If the EpiPen makes the federal preventive list, most Americans would have no insurance copay when getting the product. That means they could obtain the medication with no direct cost, regardless of its retail price. Mylan could keep the EpiPen at the current price, perhaps raise it more, while keeping patient anger at a minimum.
Instead, the federal government, health insurers and employers would pay the bill. Those costs, in turn, could be passed on to consumers in other ways, as in higher premiums or higher copays on other drugs.
“In a way, it is brilliant,” said Rachel Sachs, a law professor who specializes in public-health policy at Washington University in St. Louis. “We are all seeing them for what they are — the poster child for high drug prices right now, but they don’t want to be. And this tactic is nothing but a self-serving move, not a public-regarding one.”
Mylan acknowledged financing “research, resource development and travel” by the nonprofit coalition Winders formed in collaboration with the company to help push for the change.
The company also pointed to steps it had taken to lower the price of the EpiPen. Mylan has announced more rebates for some patients and is preparing to release a less expensive generic version.
The decision about whether to label EpiPens a preventive drug will fall to the U.S. Preventive Services Task Force, a federally appointed group of physicians and public-health experts. The group reviews disease screenings, counseling and other treatments to determine if they are sufficiently effective to make the list. Under the Affordable Care Act, certain recommendations from the task force must be adopted by almost all insurers.
The EpiPen is an epinephrine auto-injector, meaning it contains a portable supply of epinephrine that can be quickly administered to a person suffering from an allergic reaction.
Getting the designation could be difficult, since there are no prescription medications for diagnosed illnesses on the preventive list. The task force has recommended at least one over-the-counter medication: aspirin. Items that make the list typically include shots and cancer screenings. The task- force chairwoman, in a statement, appeared to all but rule out adding EpiPens to its list of recommendations.
But a review of Mylan’s lobbying history makes clear that the company has an exceptional track record at influencing government policies, in Washington and in state capitals. Heather Bresch, Mylan’s chief executive, called the effort “our unconventional approach to growing this franchise” in remarks to Wall Street analysts last year.
Mylan was actively involved in pushing a 2013 federal law encouraging schools nationwide to stock EpiPens. And the company takes credit for legislation in at least 10 states that require the product in hotels, restaurants and other places, and additional school-related legislation in nearly every state.
The company and its employees are major contributors to lawmakers, Democrats and Republicans, on Capitol Hill. Bresch is the daughter of Sen. Joe Manchin, D-W.Va.
Effectively pushing such arguments through various public-awareness campaigns has helped expand the epinephrine auto-injector market. The product accounts for 99 percent of the market’s $1 billion in sales in the first six months of this year, the research firm IMS Health estimates.
With company support, Winders’ organization hosts conferences every year that bring together allergists, pediatricians, school nurses and elected officials. At the conferences, held in St. Louis; Orlando, Fla.; and Las Vegas this year, the attendees detailed plans to help win passage of legislation intended to increase the distribution of epinephrine.
For the preventive-drug push, Winders has been joined by representatives from other allergy organizations, all with somewhat similar financial ties to Mylan. They include the American Latex Allergy Association, the Food Allergy & Anaphylaxis Connection Team and the Asthma and Allergy Foundation of America.
Eleanor Garrow-Holding, president of the Ohio-based Food Allergy & Anaphylaxis Connection Team, said the effort was “initiated by Mylan” and acknowledged that her group also receives annual grants from the company.
After The Times raised questions about the arrangement, she added in an email that Mylan was “not part of this task force moving forward. Only the patient advocacy groups are actively participating.”
In addition, Winders and Garrow-Holding both took offense at the idea that Mylan’s money had affected their organizations’ work.
But at least two groups, including the American College of Allergy, Asthma and Immunology, declined to participate in the effort, citing the appearance of a conflict of interest.
Dr. Bobby Quentin Lanier, executive medical director of the nonprofit group of allergy doctors, said his group had spurned Mylan’s offer of payments for a series of papers focused on “the possibility of adding the epinephrine auto-injector to the national preventive drug list.”
“As we looked at it, we thought, ‘No way that we could do that,’ ” Lanier said.
The effort to get epinephrine auto-injectors on the preventive list is moving ahead.
Winders said her group planned to send a formal submission to the U.S. Preventive Services Task Force in November.