Did Mylan Oversell EpiPen, or Fill an Unmet Need?

Alicia Ault

October 28, 2016

After Mylan Pharmaceuticals acquired the EpiPen business, not only did the price rise exponentially, but the number of prescriptions shot up as well, more than doubling in a 7-year period for Medicare beneficiaries alone. Members of Congress — who have already been pressuring Mylan on its pricing of the epinephrine autoinjectors — are now also looking into whether the company inappropriately promoted the EpiPen, creating a need where perhaps there was none.

Clinicians, however, say the unmet need is real — that allergies and anaphylaxis have been on the rise, and, if anything, epinephrine autoinjectors should be even more widely available. The conundrum: Mylan's aggressive promotion, combined with professional society guidelines urging wider use, has created a huge demand for a product that is largely unaffordable, thanks to Mylan's equally aggressive price increases.

Practitioners "who used to see three kids in a month may now see three in a day," said Robert Alan Wood, MD, director of pediatric allergy and immunology at Johns Hopkins Hospital, Baltimore, Maryland. He attributes the increase in visits in part to better education and rising awareness among physicians, patients, and families.

But, it's a double-edged sword. Patients and families are seeking more prescriptions more often, and because the consequences of not having an injector can be so dire, "the tendency will be to overprescribe, and we'd say that's a justifiable over-prescription," Dr Wood told Medscape Medical News. Increasingly, however, patients can't afford that measure of protection, he said.

Mylan has helped raise anaphylaxis awareness, but it has focused too much on its business and not enough on patients, said Michael Pistiner, MD, a pediatric allergist with Harvard Vanguard Medical Associates, Boston, Massachusetts. "Things just clearly got out of hand," Dr Pistiner told Medscape Medical News. "Now there's an access problem."

Huge Uptick in Prescriptions

Mylan bought the EpiPen business in 2007 from the German drug maker Merck, and since that time millions of Americans have gained access to EpiPens, despite the rising price.

The Kaiser Family Foundation reported in September 2016 that Mylan had increased the list price for a pack of two EpiPens nearly 550%, from $94 in January 2007 to $609 in May 2016. The foundation found that the number of Medicare users grew by 164% from 2007 to 2014, from about 80,000 to 211,500. Prescriptions increased from 98,000 in 2007 to 255,000 in 2014. Medicare spent $80 million on EpiPen prescriptions in 2014, while Medicare enrollees spent $8.4 million out of pocket on the injectors.

The impact on Medicaid has been even greater. Medicaid covers more than 30 million children, which makes it a major payer for autoinjectors, said Kaiser. The foundation found that from January 2011 through June 2015, Medicaid paid for 2.7 million epinephrine autoinjector prescriptions — mostly EpiPens — or an average of nearly 600,000 per year.

The number of EpiPen prescriptions written for Medicaid recipients rose from 71,000 in 2011 to 189,000 in the first half of 2015, according to Kaiser's data. Meanwhile, Medicaid spending for EpiPen (before any rebates from Mylan) increased from $25 million in the first half of 2011 to $140 million in the first half of 2015.

Prescriptions are on the rise for the privately insured as well. In September 2016, Athena Health reported that the number of prescriptions for EpiPens written by providers who use its electronic network had grown by 14% since the previous year.

Unmet Need?

Mylan has contended that its promotion of EpiPen — which has included campaigns and lobbying efforts to make it available in all public spaces — is delivering a valued therapy to patients in need.

Clinicians agree — in part. "There is a genuine rise in food allergy and anaphylaxis," said Dr Pistiner. And, he said, "There is an agreed-upon need for the availability of epinephrine."

But defining the need is imprecise. Good data on allergies and anaphylaxis are not easy to come by. A big issue: anaphylaxis can't be easily predicted.

Dr Wood said an estimated 2% to 3% of the overall US population, and 4% to 8% of children have food allergies — the primary cause of pediatric anaphylaxis. He was the lead author on a 2014 report that found that anaphylaxis occurs in 1 in 50 Americans (1.6%), and possibly as many as 1 in 20 (5.1%). The article ( J Allergy Clin Immunol. 2014;133:461-467) was a project of the Asthma and Allergy Foundation of America and was funded by Sanofi.

Mylan estimates that 43 million Americans are at risk for anaphylaxis. The company's CEO, Heather Bresch, told a US House committee in September 2016 that when the company bought the EpiPen business, "fewer than 1 million of the 43 million people at risk had access to an epinephrine auto-injector."

Anaphylaxis kills 1500 Americans a year, said Bresch, adding that Mylan has spent $1 billion in the last 8 years increasing awareness. A company spokesperson told Medscape Medical News that since Mylan began selling the EpiPen, "80% more patients have access to treatment and are better prepared to respond should anaphylaxis occur."

The company also has pushed for the EpiPen to be available in public settings like restaurants. Thirty states now have laws allowing restaurants, colleges, and emergency responders to stock and administer epinephrine injectors, said Mylan.

The drug maker was also the primary mover behind the School Access to Emergency Epinephrine Act, signed into law by President Barack Obama in 2013. The law gives additional funding to states for asthma-treatment grants if they: maintain an emergency supply of epinephrine (designated as "EpiPens" in the White House press release); permit trained personnel of the school to administer epinephrine; and develop a plan for ensuring that trained personnel are available to administer epinephrine during all hours of the school day. Mylan has also given out 700,000 free EpiPens to schools.

Dr Pistiner believes epinephrine injectors should be available in every school. In Massachusetts, he said, the latest data indicates that in a student population of one million, 220 epinephrine doses were administered in 2010. Of those, 25% were given to children who had no known history of allergies — showing the unpredictability of anaphylaxis, he said.

Prescriptions aren't just being driven by Mylan's sales force or lobbying, said Dr Pistiner and Dr Wood. Guidelines put out in 2010 by the National Institute of Allergy and Infectious Diseases consensus panel ( J Allergy Clin Immunol. 2010;126:S1-S58) on diagnosis and management of food allergy has been extremely influential, they said. The panel recommended that two-dose autoinjector prescriptions be given to patients with: a history of a prior systemic allergic reaction; food allergy and asthma; and, a known food allergy to peanut, tree nuts, fish, and crustacean shellfish.

The guideline "is probably driving a whole lot of these prescriptions," said Dr Pistiner.

Another factor that has increased the number of EpiPens sold — and directly benefited Mylan — is the consensus that patients should always be prescribed at least two injectors, said Dr Wood. A 2010 study ( Pediatrics. 2010;125:e711–e718) that found that 12% of children with food allergies required two doses to stop the severe reaction has helped make the case.

Parents — who are understandably concerned — also have started asking for more prescriptions, said Dr Wood. They often "want to have more EpiPens than they really need," he said. "We usually say OK," he said, but notes that "it's way less than 1% of patients who use those in a given year."

Legislators Take Aim

Senator Chuck Grassley (R-IA), chairman of the Senate Judiciary Committee, for one, wants to know why EpiPen sales have risen so much. The company has "received a lot of money from taxpayers," he said in a statement in early October.

The Senator asked Mylan to produce evidence — including any peer-reviewed studies — that it helped fill an unmet need for epinephrine injectors. And, he said his staff would continue to investigate whether Mylan had ripped off the federal government.

About the same time, Mylan announced that it was paying the federal government $465 million to settle allegations that it had falsely claimed the EpiPen was a generic product for purposes of calculating Medicaid rebates.

Sen. Grassley, however, was not satisfied. He's announced a Judiciary Committee hearing on November 30 to examine the settlement.

Sen. Richard Blumenthal (D-CT) — who had previously joined18 other Senators calling for an investigation into EpiPen pricing — also called for further investigation. "This settlement is a shadow of what it should be — lacking real accountability for Mylan's apparent lawbreaking," said Sen. Blumenthal, in a statement.

In the meantime, clinicians and patients continue to look for affordable EpiPen alternatives. Auvi-Q, an EpiPen competitor, was withdrawn voluntarily from the market in October 2015 by its manufacturer, Kaleo. The company recently said it plans to reintroduce its autoinjector in 2017. Another competitor, Adrenaclick (Amedra Pharmaceuticals), can be less expensive than EpiPen — from $200 to $500 for a two-pack — but is still no bargain.

Mylan said it will soon offer its own $300 generic version of the EpiPen, but that product is not available yet.

Dr Pistiner said he hopes for relief soon. "When people need to make hard choices that could potentially compromise their child's health and well-being then we know we have ourselves a problem," he said. "Putting families in this position is totally unfair."

Dr Pistiner and Dr Wood disclosed no relevant financial relationships.

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