Aimmune Therapeutics a biopharmaceutical company developing treatments for life-threatening food allergies, cautions stakeholders against drawing conclusions from the Institute for Clinical and Economic Review’s (ICER’s) final report on emerging desensitization treatments for peanut allergy. In its review, ICER fails to incorporate available data on both long-term outcomes and quality-of-life. ICER’s analysis and the public meeting discussion discounted patient and community perspectives on the physical, social and psychological benefits of desensitization. The resulting final report is biased against immunotherapy, generally, and fails to specifically capture the full value of AR101.

Aimmune joins advocates and clinical experts asking payers and policymakers to engage in more thoughtful, unbiased consideration of available evidence—including patient perspectives on quality-of-life improvements and relief from the stress and fear of accidental exposure—when evaluating emerging treatments for peanut allergy.

In clinical trials, AR 101, Aimmune’s investigational biologic drug for use in oral immunotherapy, has demonstrated the ability to increase the median tolerated dose of peanut protein by 100-fold in each of its two pivotal Phase III clinical trials. While the report found AR 101 to be cost-effective well below traditional health economic thresholds, ICER failed to acknowledge the availability of the positive long-term efficacy and quality-of-life data from the PALISADE open label follow-on study, as well as the clinical outcomes data from the European Phase III ARTEMIS trial. These data were recently presented at the 2019 European Academy of Allergy and Clinical Immunology (EAACI) Congress and shared with ICER in May under its “academic in confidence” policy and throughout the review process including the June 11 public meeting. ICER did not acknowledge or incorporate the existing data in its final evidence report or the associated cost-effectiveness analysis.

Comment: ICER, or the Institute for Clinical and Economic Review, reported on three peanut allergy treatments. They were DBV Technologies' Viaskin Peanut, expected to be resubmitted to U.S. regulators in the third quarter; Aimmune Therapeutics' AR 101, which has an advisory committee meeting in September; and non-commercialized oral immunotherapy. ICER contends that DBV and Aimmune have not shown their drugs can provide this effect long-term — or, even more broadly, offer quality of life improvements.