After Grassley decries 'incomplete response,' Mylan agrees to pony up EpiPen docs

By Tracy Staton Sep 13, 2016 9:50am

Congress is starting to get some answers on EpiPen pricing. And though, so far, Mylan’s not offering much beyond what’s readily available via Google search, that could change later this week.

The House Committee on Oversight and Government Reform, which demanded answers earlier this month, is expecting documents late this week, sources close to the investigation said. The committee had set a deadline for initial word from the company Monday.

After the committee has a chance to sift through submitted documents, more details about Mylan’s pricing, marketing, supply chain and hard costs could be forthcoming. If so, then that’s more than Sen. Charles Grassley received in the company’s responses to his pricing questions. Some of those queries were rather specific, but the answers, by contrast, weren’t specific enough, the Republican senator said.

“[I]t’s an incomplete response and wouldn’t satisfy my constituents who are upset about the EpiPen price increases,” Grassley said in a Friday statement. “It doesn’t provide the full picture that I requested, and it doesn’t answer all of my questions.”

Anyone closely following the EpiPen controversy would recognize the rhetoric in Mylan’s letter to Grassley. It calls pricing “complicated.” It points to Sanofi’s high pricing on its own Auvi-Q competitor, since pulled from the market. It says EpiPen revenue helps fund R&D.

To questions about its patient-assistance spending, Mylan outlined the new copay discounts and assistance announced last month. The unsigned letter also touted Mylan’s anaphylaxis awareness campaigns--the sort of campaigns pharma commonly uses to build demand for its products--and cites its lobbying for epinephrine use in schools as simply a public service, rather than an effort to build sales in the process.

During the company’s Q2 earnings call, Mylan told a different story to investors: “I want to stress that we continue to invest in expanding the size of the overall market by increasing awareness and access,” Chief Commercial Officer Anthony Mauro said.

The letter does set out some dollar figures; it says Mylan spent $143 million on its copay discount card over the last 5 years--one direct answer to a question--and cites $80 million in spending on 700,000 free EpiPens for schools, a program that began in 2012. That would be about $24 million annually, on average, for copay assistance and perhaps $20 million, on average, on EpiPens for schools.

Just to put that in context, the size of Mylan’s EpiPen and anaphylaxis ad budget, according to the letter: $98 million last year, $43 million so far in 2016.

In another repeat to previous arguments, Mylan assigns blame for EpiPen’s high cost to patients, not to its own price increases, but to insurers and wholesalers taking their cut--and to high-deductible insurance plans that offload costs to consumers. The latter is a particular problem for patients and isn’t under Mylan’s control.

But the former applies to every drug on the market, those with big price increases and those with small ones.

And to that point, Mylan executives attributed EpiPen sales growth for the second quarter partly to “net price favorability, due in part to payer pricing dynamics.” In other words, the “cut” to middlemen was actually smaller for the period.

“[F]avorable pricing” was an element to EpiPen’s sales growth in 2015, according to the company’s year-end earnings statements.

Mylan faces plenty of other questions from Congress, not to mention calls for investigations by several federal agencies; a flurry of letters has arrived at company headquarters and DC offices in recent weeks, as Wells Fargo analysts noted in an investor note Tuesday.

Senators, representatives and committees in both houses started by demanding information on EpiPen pricing and marketing practices, urging the FDA to hustle competitors to market, and calling on the Federal Trade Commission to assess Mylan’s EpiPen monopoly.

Since then, they’ve asked the Centers for Medicare and Medicaid Services and the Department of Health and Human Services to look into how EpiPen price hikes have affected spending by Medicare, Medicaid and other federally-funded programs. Several are calling for public hearings, a la those earlier this year, when Valeant executives were called on the Congressional carpet, literally, to explain their own company's price hikes.

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