The company said the Institute for Clinical and Economic Review (ICER) failed 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, it added.
"The resulting final report is biased against immunotherapy, generally, and fails to specifically capture the full value of AR101," the company said.
In clinical trials, Aimmune said AR101 had 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 ICER report found AR101 to be cost-effective well below traditional health economic thresholds, it failed to acknowledge the availability of the positive long-term efficacy and quality-of-life data from an open-label follow-on study, as well as the clinical outcomes data from the European phase 3 Artemis trial, the company said.
The FDA granted AR101 Fast Track Designation in 2014 and Breakthrough Therapy Designation in 2015 for peanut-allergic children and adolescents ages 4 years to 17 years. The agency's Allergenic Products Advisory Committee will review the company's Biologics License Application for AR101 at a meeting set for Sept. 13.
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