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ll too often, parents of children with food allergies are forced to make hard choices. Many are splitting up twin packs of EpiPens, others are keeping them past their expiration dates, delaying filling the prescription, or, even worse, not filling prescriptions at all. How did we get into this situation, and what must we do to keep kids with food allergies safe?

Last week’s Capitol Hill hearing on the price of EpiPens and the epinephrine auto-injector market was quite a spectacle. Members of Congress expressed bipartisan outrage over price increases and the near-monopoly this product has on the epinephrine auto-injector market. The confrontation, while dramatic, provided little insight into the reasons behind the price hikes.

The hearing was a start. But there is more to be said and done.

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In the United States, every three minutes a food allergy reaction sends someone to the emergency department. That adds up to more than 200,000 emergency room visits per year. One in 13 children — or roughly two in every classroom in the United States — lives with a life-threatening food allergy.

Epinephrine auto-injectors are neither niche products nor optional “nice to have” prescriptions. They are the only treatment proven to halt a food allergy reaction before it becomes deadly.

The good news is that the controversy over EpiPen pricing has brought important attention to the daily challenges faced by Americans living with life-threatening food allergies. The epinephrine auto-injector market in this country is a remarkable microcosm of almost every issue facing the pharmaceutical market in the United States: challenges of access and affordability, lack of meaningful competition, and pockets of limited innovation.

Natalia Bronshtein/STAT Source: Elsevier Clinical Solutions’ Gold Standard Drug Database

Adults need these devices as well as children, which highlights issues of extended patent protection for drugs tested for pediatric use. Epinephrine auto-injectors are device-drug combinations, which raises unique regulatory challenges for their manufacturers. Constraints on drug importation to deal with drug shortages or monopoly situations and slow progress towards harmonization of approval paths between the US and EU — where four epinephrine auto injectors are approved and available — are also part of this story. It is becoming clear that many entities, including insurers, pharmacy benefit managers, and other intermediaries, all play major but poorly understood roles in what US consumers pay for EpiPens.

Why is this controversy erupting now? Certainly the size and timing of the price hikes played a role. But less discussed is a change in how insurance covers access to prescription medications. In less than a decade, average health care deductibles have risen from approximately $300 to more than $1,000, with some families now facing annual deductibles of almost $5,000. In that same time period, the percentage of individuals enrolled in high-deductible insurance plans has gone from less than 5 percent to potentially approaching 40 percent in the coming year. This means that a family whose fixed copay a few years ago was $25 or $50 per prescription for their twin pack of EpiPens could get the recommended multiple sets for school, home, and to carry around for about $75 to $150. Today, many are now required to pay list price — upwards of $600 — for each set, or almost $2,000 to satisfy their deductibles.

The problem isn’t limited to individuals with food allergies. The cost of an albuterol inhaler for asthma, once less than $15, has risen 300 to 600 percent. Insulin prices have more than tripled in a decade as well. What’s going on? There has been a seismic shift in the way health insurance works — or doesn’t work — for patients in the US. Families are stymied by the lack of transparency among insurers, manufacturers, and pharmacy benefit managers, whose secret negotiations leave patients without affordable options.

Access to affordable epinephrine auto-injectors is an enormous patient safety issue. We must move with urgency to address both the acute need for epinephrine access as well as the systemic reforms that will ultimately drive increased competition, innovation, and safety for people with food allergies. A single life lost due to lack of affordable epinephrine auto-injectors is unacceptable and represents a clearly avoidable tragedy.

The hearing by the House Committee on Oversight and Government Reform was the start of this important conversation, but it must not be the end.

James R. Baker Jr., MD, is CEO and chief medical officer of Food Allergy Research & Education (FARE), the leading national organization working on behalf of the 15 million Americans with food allergy. FARE has received corporate support from the distributor of EpiPen. On Sept. 7, the organization announced that until meaningful competition exists in the epinephrine auto-injector space, it will no longer accept donations from companies marketing these devices. 

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