Cheaper, generic unit of EpiPen in the works

Price of new version $300, half of other

In this July 8, 2016, file photo, a pharmacist holds a package of EpiPens epinephrine auto-injector, a Mylan product, in Sacramento, Calif.
In this July 8, 2016, file photo, a pharmacist holds a package of EpiPens epinephrine auto-injector, a Mylan product, in Sacramento, Calif.

Drugmaker Mylan said Monday that it will start selling a cheaper version of its EpiPen after encountering criticism over a list price for the emergency allergy treatment.

The price has grown to $608 for a two-pack, making it unaffordable for many patients.

EpiPens are used to treat severe allergies to insect bites and foods such as nuts and eggs that can lead to anaphylactic shock. People usually keep a number of Epi­Pens handy at home, school or work. The syringes, filled with the hormone epinephrine, expire after a year.

Consumers and politicians have accused the company of price-gouging, since the list price for a pair of EpiPens has climbed from around $94 in 2007, when Mylan acquired the product.

The drugmaker said it will start selling the lower-price generic version of the EpiPen in several weeks. It was described as identical to the branded option but will have a list price of $300 for a two-pack. It will be available in both 0.15-milligram and 0.30-milligram strengths, as is the current version on the market.

"We understand the deep frustration and concerns associated with the cost of EpiPen to the patient, and have always shared the public's desire to ensure that this important product be accessible to anyone who needs it," Mylan Chief Executive Officer Heather Bresch said in a statement. "Our decision to launch a generic alternative to EpiPen is an extraordinary commercial response."

On Monday, Reps. Jason Chaffetz, R-Utah, and Elijah Cummings, D-Md., heads of the House Committee on Oversight and Government Reform, wrote to Bresch, requesting documents and communications regarding Mylan's revenue from EpiPens since 2007, manufacturing costs and how much Mylan receives from federal health care programs.

Joshua Sharfstein, a professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health, called the plan to release a generic version of the EpiPen a face-saving move by the company. The generic offers a way of dropping the price of one version of the drug, while also bringing the company some benefits, Sharfstein said. It will allow Mylan to segment the market, because some people will continue to buy the brand-name product.

Sharfstein said one important question will be whether the price stays the same over time.

Bresch defended the price increases last week, saying the company only received $274 of the total price for a twin-package while insurers, pharmacies and other parties divvy up the rest.

Last week, Mylan said it was expanding programs that help people pay for EpiPens. It doubled the limit for eligibility for its patient assistance program, so a family of four making up to $97,200 would pay nothing out of pocket. It also said it will offer $300 copay cards, up from the current $100 per-prescription savings.

A company representative said Monday that the $300 cards would be available only for the branded version, but patients could use its assistance program for both the branded and generic versions of the medicine.

That raises the question of whether consumers will actually pay less for the generic version, said Walid Gellad, who heads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. If patients don't see cost savings, Mylan can place the blame on insurers for not lowering out-of-pocket expenses, Gellad said. The company has already pinned the blame for high consumer prices on insurers and pharmacy benefits managers, or PBMs.

"If it turns out that patients still have to pay huge amounts for the EpiPen, I think Mylan can say, 'We lowered the price and this is on insurers and PBMs,'" he said.

How much an individual pays for an EpiPen prescription can depend on insurance coverage.

Pharmacy benefits managers, which negotiate drug prices for insurers and employers, often get discounts off a drug's list price, and patient out-of-pocket costs can vary by plan. For instance, customers of Express Scripts Holding Co., the nation's largest prescription benefits manager, pay $73.50 on average, a price the company has kept fairly stable for a couple years.

Mylan said that last year nearly 80 percent of its patients with commercial insurance paid nothing out of pocket for an EpiPen prescription because of its savings card.

Uninsured patients or those with high-deductible coverage might be stuck paying the full price for the prescription, if they are unaware of Mylan's savings options. High-deductible coverage can require patients to pay thousands of dollars toward medical care or prescriptions before most coverage kicks in.

Mylan specializes in selling generic drugs, which are lower-priced equivalents to branded medications. Offering a generic version of the EpiPen can help the drugmaker protect its market share from competition.

Mylan's announcement Monday came a few days after the compounding pharmacy Imprimis Pharmaceuticals said it might be able to sell a version of the allergy treatment in a few months and would likely charge around $100 for two injectors.

There is currently little competition for EpiPen, with the only rival product being Adrenaclick, which carries a list price of $461. But that could change.

At least two companies are trying to get U.S. approval to sell a rival brand or generic version of EpiPen. None is likely to hit the U.S. market until well into next year.

Mylan NV stock rose 19 cents, or 0.4 percent, to close Monday at $43.22.

Mylan is the latest drugmaker facing criticism for price increases. Martin Shkreli and executives from the company he once lead, Turing Pharmaceuticals AG, and executives from Valeant Pharmaceuticals International Inc. faced congressional committees earlier this year to answer questions about why the companies bought the rights to older drugs that lacked competition and then raised the prices.

Information for this article was contributed by Tom Murphy, Damian Troise, Michelle Chapman and Linda A. Johnson of The Associated Press; by Carolyn Y. Johnson of the Washington Post; and by Anna Edney and Cynthia Koons of Bloomberg News.

A Section on 08/30/2016

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