June 12, 2019

The following statement is posted regarding the ongoing review of the comparative clinical effectiveness and value of treatments for peanut allergy currently being conducted by the Institute for Clinical and Economic Review (ICER) and is co-signed by the following organizations: Food Allergy Research & Education (FARE), the American College of Allergy, Asthma and Immunology and the Allergy & Asthma Network.

On Tuesday, June 11, 2019, ICER convened a meeting of the California Technology Assessment Forum to review its assessment of Viaskin® Peanut (DBV Technologies) and AR101 (Aimmune Therapeutics), two therapies designed to induce immune tolerance.

These emerging therapies represent the most significant breakthroughs to date for patients managing food allergies and their caregivers. Peanut allergy, a life-altering and potentially life-threatening disease, affects between 1.4-4.5% of children in the U.S. It is a disease that carries a psychosocial and financial burden.

Currently, the only treatment for food allergy is avoidance — or a shot of life-saving epinephrine, followed by a visit to the emergency room, when a severe reaction occurs. Avoidance and epinephrine is not a therapy.

The food allergy community – patients, caregivers, clinicians, researchers and advocates – has been waiting years for FDA approval of therapies that will offer protection from life-threatening food allergy reactions, which send someone in the U.S. to the emergency room every three minutes.

We thank ICER for the extensive work undertaken to collect and review evidence and data, and for engaging with a variety of stakeholders throughout this process. While ICER appropriately took into account the psychosocial burden of peanut allergy in its assessment, recognizing recently published quality-of-life data, we are discouraged that ICER did not more thoroughly consider the complexity and nuances of available research on immunotherapy in evaluating the benefit these therapies can have on patients managing peanut allergy.

Analyses of research on oral immunotherapy published in peer-reviewed journals show that desensitization is effective for most patients with peanut allergy. This is not in dispute. We agree that more data on the long-term benefit and protection that can be achieved are needed. However, we have serious concerns about the impact of using computed data on reactions during therapy on ICER’s evidence rating without appropriate consideration of the distinctions between medical risks occurring with predictable adverse events during therapy and an unforeseen accidental exposure to peanut in an environment where no emergency treatment is readily available. These therapies shouldn’t be assessed without a deep understanding of the patient journey, including the trade-offs that patients are willing to make for the potential benefit they will gain. Patient preference and expectations around outcomes must be paramount to consider in this analysis.

As organizations representing the voice of patients and thousands of practicing allergists, we are disappointed that ICER did not adopt a more patient-driven approach in assessing the value and benefit of AR101 and Viaskin Peanut. We strongly urge ICER in its final report to reach a decision that ultimately increases their accessibility and takes into account the true impact of treatment and the breakthrough nature of these therapies.