To achieve commonly cited thresholds for cost-effectiveness, the annual price would need to be between $4,800-$7,200 for AR101 and $3,000-$4,500 for Viaskin Peanut; The CTAF will vote on the net benefit of treatments during June 11 public meeting —

BOSTON, May 28, 2019 – The Institute for Clinical and Economic Review (ICER) today released an Evidence Report assessing the comparative clinical effectiveness and value of two investigational technologies that treat children with peanut allergy by building their immune tolerance to peanuts.

The report evaluates Viaskin® Peanut (DBV Technologies), AR101 (Aimmune Therapeutics), and non-commercialized oral immunotherapy (OIT). An FDA decision on AR101 is expected by January 2020. A biologics license application for Viaskin Peanut was withdrawn in December 2018, but is expected to be resubmitted later this year.

“Currently there are no FDA-approved treatments for patients with peanut allergy, and the potential for accidental exposure to peanuts can create tremendous anxiety for patients and particularly for their caregivers,” said David Rind, MD, ICER’s Chief Medical Officer. “Viaskin Peanut and AR101 have the potential to reduce the risk of a serious reaction by desensitizing patients to the allergen, and in turn, reduce levels of stress and anxiety about accidental exposure. However, these therapies do not allow patients to intentionally consume peanuts nor caregivers to stop being vigilant, and neither treatment is without risks of serious side effects.”

This Evidence Report will be the subject of an upcoming public meeting of the California Technology Assessment Forum (CTAF), in Oakland, CA on June 11, 2019. CTAF is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.

A draft version of this report was previously open for a four-week public comment period. The updated Evidence Report and voting questions reflect changes made based on comments received from patient groups, clinicians, drug manufacturers, and other stakeholders. Detailed responses to public comments can be found here.

Key Findings

  • The evidence provides moderate certainty that Viaskin Peanut and AR101 provides a net health benefit that is at least comparable to strict peanut avoidance. Due to the lack of head-to-head clinical trials and inconsistent trial designs, the evidence is insufficient to compare the clinical effectiveness of each treatment to the other.
  • Based on the clinical trial data, there are important tradeoffs between the clinical benefits and harms for the therapies under review. Compared to Viaskin Peanut, the higher rate of desensitization with AR101 is balanced by a higher rate of adverse events, epinephrine use, and discontinuation of therapy.
  • The evidence was insufficient to demonstrate a net health benefit of non-commercialized OIT in comparison to strict peanut avoidance.
  • To achieve commonly cited thresholds for cost-effectiveness of between $100,000 and $150,000 per quality-adjusted life year (QALY) gained, AR101 would need to be priced between $4,800-$7,200, and Viaskin Peanut would need to be priced between $3,000-$4,500.

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.

ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.