Aimmune cautions stakeholders on ICER report on treatments for peanut allergy
Aimmune cautioned stakeholders against drawing conclusions from the Institute for Clinical and Economic Review's, or ICER's, final report on emerging desensitization treatments for peanut allergy. The company said, "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, AR101, 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 3 clinical trials. While the report found AR101 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 3 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. Additionally, ICER failed to consider the potential for long-term disease modification consistent with allergen immunotherapies and mischaracterized the allergic response associated with immunotherapy as a harm, rather than an expected, well understood and easily managed part of the immunotherapy process. With all immunotherapy, allergic reactions are expected and acceptable in the short term in exchange for long-term desensitization to protect against accidental exposure. In clinical trials, median tolerated dose for AR101-treated patients improved from 10mg at baseline to 1000mg at month 12 to 2000mg at month 18-demonstrating both the potential for long-term disease modification and the potential for significant protection against the average real-world reaction-provoking exposure of 125mg, or half a peanut." The FDA's Allergenic Products Advisory Committee, or APAC, will review Aimmune's biologics license application, or BLA, for AR101 at its meeting scheduled for September 13. The FDA accepted the BLA for AR101 in March and previously informed Aimmune that completion of its review would be targeted by late January 2020.