FARE Responds to Final ICER Review of Breakthrough Peanut Allergy Therapies

McLEAN, Va. (July 11, 2019) – Today, Food Allergy Research and Education (FARE), the world’s largest private funder of food allergy research, expressed its deep concerns with the final evidence report on two breakthrough peanut allergy therapies issued Wednesday by the Institute for Clinical and Economic Review (ICER)—a nonprofit that reviews the value of medical treatments and devices. FARE believes ICER’s findings on AR 101 (Aimmune Therapeutics) and Viaskin® Peanut (DBV Technologies) could negatively impact the accessibility of these treatments, which represent the most significant developments in the quest to find new treatments and, eventually, a cure for life-threatening food allergies.

FARE will be working directly with the patient community to ensure their voices are heard and they have affordable access to these products when they enter the marketplace.  

The final evidence report, which found the clinical evidence for both treatments does not yet demonstrate that the long-term benefits of desensitization outweigh the short-term risks, is based on unrealistic expectations for first-ever approved therapies and lacks input that represents the 32 million Americans living with food allergies. FARE thanks ICER for the opportunity to share the patient perspective throughout its review process; however, we are extremely disappointed at the insufficient recognition of the unique issues the food allergy community faces in its final report.

“Avoidance, epinephrine and emergency room visits can no longer be the norm for the more than 32 million Americans living with food allergies today,” said FARE CEO Lisa Gable. “Our community needs choices. New and innovative therapies, like those that have just undergone this rigorous ICER review, are important potential therapeutic options for the growing number of food allergic patients that currently have no other options. While we appreciate the opportunity to have been part of the ICER process, it’s troubling that ICER did not give appropriate weight to the perspective of patients with the most on the line when it comes to food allergy treatments,” she said.

While ICER’s cost-effectiveness model is limited to the direct medical costs associated with the treatment of peanut allergy, the final evidence report includes recently-published survey data that more accurately captures the significant daily burden peanut allergy patients and their caregivers currently face following extensive input from the community, including FARE. We maintain that it is unfortunate that ICER’s cost-effectiveness model did not include patient-focused secondary considerations and that its evidence rating was influenced by a one-way interpretation of adverse events associated with treatment while diminishing the patient perspective. Allergy immunotherapy consists of administering peanuts to peanut allergic patients and is expected to carry a risk of allergic reactions during therapy. ICER’s review did not consider the substantial difference between an anticipated adverse event in a controlled environment and an unanticipated allergic reaction resulting from an accidental exposure. Ultimately, it is essential that patients are fully informed on the risks and benefits of any therapy to make an educated choice in consultation with their doctor. Going forward, we strongly encourage payors to assess these therapies with an emphasis on the patient experience, and the risks patients are willing to take to undergo what can be a life-changing treatment.

At a June convening of ICER’s California Technology Assessment Forum (CTAF), community advocates, patients, pharmaceutical representatives, insurance companies, doctors and many more discussed the value of each of these therapies and how they will come to market, assuming FDA approval. 

“Food allergy experts, patients and families came together to urge ICER to take their experiences into account during its evaluation of these treatments. The passion that was shown by patient advocates and the doctors and researchers who have treated countless patients with food allergies was inspiring,” said Nurry Hong, FARE’s chief of strategy and innovation, who represented the organization at the CTAF meeting in June and is a food allergy dad. “Unfortunately, ICER did not truly consider the realities food allergy families face every day, and when it comes to assessing the value of these treatments to the community they are intended to benefit, ICER’s report fell short.” 

FARE is working on multiple fronts to transform the research landscape, including expanding the FARE Patient Registry to measure real-world evidence, including surveillance of approved drugs after market approval, hosting an Oral Immunotherapy Summit this fall, supporting research on innovative diagnostics and collaborating with our medical advisors on decision-support tools to educate patients and physicians about tradeoffs of any therapy option.

Additionally, FARE is actively encouraging Congress to pass the FASTER Act, a package of federal policy changes that will improve the health, safety and inclusion of the 32 million Americans living with food allergies. 

As FARE continues to support groundbreaking research into new food allergy treatments, we look forward to working with all relevant parties to ensure we are part of the solution, and can collaboratively find a cure for this disease.