Last year, more than 3.6 million U.S. prescriptions for two-packs of EpiPens, used to ward off potentially fatal allergic reactions, were issued. It cost around $94 nine years ago. The average cost was more than six times that in May.
Members of Congress are demanding more information on why the price for lifesaving EpiPens has skyrocketed.
A two-dose package of the injection device, used to ward off potentially fatal allergic reactions, cost around $94 nine years ago. The average cost was more than six times that in May, according to the Elsevier Clinical Solutions’ Gold Standard Drug Database.
Members of Congress are expressing rising alarm about the increasing costs, and they are hearing from anxious parents.
Cost of a two-dose EpiPen package in 2007, before Mylan acquired the product
Cost of the package in May
Elsevier Clinical Solutions’ Gold Standard Drug Database
Sen. Charles Grassley, R-Iowa, who heads the Judiciary Committee, was the latest to weigh in, on Monday, sending a letter to the head of the pharmaceutical company Mylan, which produces EpiPens.
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Grassley demanded an explanation for the 400 percent price increase — to more than $600 — since the company acquired the product in 2007.
“Access to epinephrine can mean the difference between life and death, especially for children,” Grassley wrote, noting that many of the children who need EpiPens are enrolled in government health-care programs. “It follows that many of the children who are prescribed EpiPens are covered by Medicaid, and therefore, the taxpayers are picking up the tab for this medication.”
Sen. Amy Klobuchar, D-Minn., earlier called for a Judiciary Committee inquiry into the pricing and an investigation by the Federal Trade Commission.
“Many Americans, including my own daughter, rely on this lifesaving product to treat severe allergic reactions,” she wrote to the head of the commission.
Last year, more than 3.6 million U.S. prescriptions for two-packs of EpiPens were filled, according to data firm IMS Health.
Two other senators, Democrats Mark Warner of Virginia and Richard Blumenthal of Connecticut, also wrote the company about the high prices. Warner said in a letter Tuesday that the issue is personal for him.
“As the parent of a child with severe allergies, I am all too familiar with the life-or-death importance of these devices,” Warner wrote.
Rep. Grace Meng, D-N.Y., on Tuesday asked the House Oversight and Government Reform Committee to hold a hearing on the issue. She is a co-chair of the Congressional Kids Safety Caucus.
EpiPen isn’t new; it has been in use since 1977. Research and development costs were recouped long ago. Nine years ago, it was bought by the pharmaceutical company Mylan, which then began to sell the device. When Mylan bought the device, EpiPens cost about $57 each. Few competitors existed, and for various reasons, that has remained the case.
Klobuchar called the Mylan price increases an application of “raw market power” by a company that controls virtually all auto-injector sales since competitors recalled or failed to get approval for similar products.
The growing criticism of Mylan’s pricing caught Wall Street’s attention Tuesday, sending the company’s shares down nearly 5 percent and slicing its market value by more than $1.2 billion.
Mylan has noted that product improvements have driven up the costs of the devices, that most EpiPens are covered by insurance and that the company also provides discounts.
Mylan said it has savings programs for patients and is also offering free EpiPens to schools. The company said around half of U.S. schools are participating in that program, which has distributed more than 700,000 free EpiPens since 2012.
Mylan also said that in 2015, nearly 80 percent of “commercially insured patients” using a company-issued savings coupon got EpiPens “for $0.”
Recent changes in health insurance have resulted in higher deductible costs for many families, the company said. “This current and ongoing shift has presented new challenges for consumers, and now they are bearing more of the cost” of the devices, the statement said.
Can’t buy just one
Most allergic reactions can be treated with diphenhydramine (Benadryl). But between 1 and 2 percent of people can develop what’s known as anaphylaxis, when the airways necessary for breathing swell and close.
Epinephrine — or adrenaline — is a hormone naturally produced by the adrenal glands. It causes your heart to beat faster, your blood vessels to constrict, your pupils to dilate and your airways to open.
Epinephrine is very, very cheap. Even in the developing world, it costs less than a dollar per milliliter, and there’s less than a third of that in an EpiPen.
But to save a life, epinephrine must be delivered quickly, and in the proper amounts. People suffering severe allergic reactions often can’t do it themselves. Drawing the drug into a syringe and then administering it to someone else requires training and precision.
What makes the EpiPen auto-injection device so special is not the drug, but the ease with which it automatically administers the correct dose without delay.
But epinephrine is inherently unstable. Research shows that it degrades over time, and it’s recommended that EpiPens be replaced every year. People in anaphylaxis need a full dose every time. They therefore need to replace all their EpiPens every year, again and again.
Children need them at home, and often stash them at school and other places away from home. So people often need to buy quite a few.
In 2010, federal guidelines changed to recommend that two EpiPens be sold in a package instead of one. Studies showed that about 10 percent of children who received epinephrine from an EpiPen needed more than one dose.
Additionally, the Food and Drug Administration changed its recommendations to allow the prescription of EpiPens for prevention for at-risk patients, not just for those with confirmed allergies. Mylan stopped selling individual EpiPens, began to sell only twin-packs, and raised prices.
In 2013, a law gave funding preferences for asthma-treatment grants to states that maintained an emergency supply of EpiPens. As the near sole supplier of the devices, Mylan stood to make even more money.
In 2012, the competing devices Adrenaclick and Twinject were discontinued. In 2013, Sanofi began to sell Auvi-Q devices, which had audio instructions. Unfortunately, they were found to give potentially improper doses, and were pulled from the shelves about a year ago.
Teva had hoped to offer a generic version of the EpiPen, but concerns from the FDA sent it back to the drawing board until at least next year.
Adamis hoped to offer prefilled syringes, which would still be harder to use than EpiPens. But it was told by the FDA that much more data would be needed before such a product could be sold.
The Adrenaclick, while still not cheap, is back and less expensive than the EpiPen. Some think it’s harder to use, though. It’s not on the accepted list for many health-insurance plans. Few physicians think of it, and therefore they write prescriptions for EpiPens.