Walk into any classroom in America today and you’ll likely find at least two children with a food allergy. More than 40% of such children have experienced a serious allergic reaction such as anaphylaxis, a severe, potentially life-threatening allergic reaction that can occur suddenly after exposure to something you’re allergic to, such as peanuts.
This epidemic doesn’t just affect children: 1 in 10 adults in the U.S. have at least one food allergy. More than 32 million Americans are currently living with food allergies. That’s the combined population of New York and Illinois.
The seriousness of this crisis is reinforced by a report commissioned by Food Allergy Research and Education (FARE), the largest private funder of food allergy research in the world, for which I am the chief medical advisor for operations. Our report showed that medical claims with diagnoses of anaphylactic food reactions rose 377% in the U.S. between 2007 and 2016.
The daily burden on those living with food allergies is high. At every meal, snack, event, and outing, they must check labels, ensure that restaurants are food-allergy friendly, and be cautious of environments where their allergen may be present, all to prevent accidental exposures and possible anaphylactic events.
People with food allergies and their families can experience lifelong issues associated with anxiety over potential allergic reactions and perceived societal stigma. For parents, having to make decisions about a child’s safety every single day, at every meal, and in every new environment can be taxing and burdensome. These obstacles are significant, under-recognized, and undertreated.
Currently, the only safe “treatment” for food allergies is avoiding foods that trigger them. But even the most vigilant individual can inadvertently eat something that could trigger a severe reaction and require a shot of lifesaving epinephrine followed by a visit to the emergency department. Avoidance and injections are no substitute for preventive therapies, and this “treatment” model is costly, challenging, and an unacceptable approach to a growing public health crisis.
Fortunately, there is hope on the horizon in the form of new treatments.
Viaskin Peanut (developed by DBV Technologies) and AR101 (developed by Aimmune Therapeutics) are two separate peanut immunotherapies that individuals can take to increase their tolerance to peanuts through controlled exposures to peanut proteins. While we still need more data on long-term outcomes, peanut immunotherapies have allowed many people to reach a certain level of protection, dramatically reducing their chances of experiencing an accidental anaphylactic reaction.
Both products are currently making their way through the Food and Drug Administration’s approval process. Together, they would be the first ever FDA-approved interventions made available to millions of people living with life-threatening peanut allergies. By providing them with a choice beyond avoidance, epinephrine, and a trip to the emergency room, these products could represent one of the most significant food allergy breakthroughs in our lifetime.
The development of immunotherapies extends well beyond peanut allergies. Work is underway to develop therapies for allergies to other foods and ingredients beside peanuts.
It’s difficult to overstate the significance of the breakthrough and value these emerging therapies represent for food allergy families and the food allergy community: They provide treatment for peanut allergies where no treatment option had existed. Desensitization to an allergen like peanuts works and offers an improved quality of life, helping remove the fear of accidental exposures. Patients with food allergies and their families deserve choices to meet their diverse needs.
The Institute for Clinical and Economic Review (ICER) — a nonprofit organization that assesses the clinical and economic value of new drugs and other innovations in health care — is currently examining the cost-effectiveness of these revolutionary treatments for peanut allergy.
Patients, parents, advocates, doctors, and others who live and work in the food allergy space understand the complexity of this disease and the overwhelming daily burden it carries. ICER itself understands this burden and has partially acknowledged it in preliminary reports. But ICER should go further in its final report to fully account for the benefit and value that these therapies can offer to patients and their families.
Specifically, ICER’s proposed base-case model for assessing these therapies focused on direct medical costs and includes a limited societal analysis perspective. This approach has the potential to significantly underestimate the true impact of the treatments. It is inherently difficult to accurately measure the costs and benefits of providing patients and families with a significantly improved quality of life that comes from a lifetime reduction in the anxiety caused by living with a peanut allergy.
The food allergy community — patients, family members, doctors, researchers, pharmaceutical companies, and more — must work with organizations like ICER to develop more accurate ways to measure the true value of food allergy therapies and collaborate on ways to ensure they are cos- effective and accessible to as many patients as possible. By working together, we can offer a new paradigm in which people with food allergies will be safe where they live, work, and play.
Thomas Casale, M.D., is the chief medical adviser for operations for Food Allergy Research and Education and professor of medicine at the University of South Florida Morsani College of Medicine.