–Midwest CEPAC to vote on the overall value of treatments during November 29 public meeting–

BOSTON, November 13, 2018 – The Institute for Clinical and Economic Review (ICER) today released an Evidence Report assessing the comparative clinical effectiveness and value of biologic treatments for asthma associated with type 2 inflammation and/or allergic asthma.

The report focuses on dupilumab (Dupixent®, Sanofi/Regeneron), omalizumab (Xolair®, Genentech/Novartis), mepolizumab (Nucala®, GlaxoSmithKline), reslizumab (Cinqair®, Teva), and benralizumab (Fasenra™, AstraZeneca). ICER previously reviewed mepolizumab for its use in severe eosinophilic asthma and dupilumab for its use in atopic dermatitis.

“All five biologics modestly reduce asthma exacerbations and improve daily quality of life,” said David Rind, MD, ICER’s Chief Medical Officer. “However, the treatments’ net prices appear to be far out of alignment with these incremental clinical benefits, and the entire therapy class would need to see price discounts of at least 50% to reach commonly cited thresholds for cost-effectiveness.”

This Evidence Report will be the subject of an upcoming public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), in St. Louis, MO on November 29, 2018. The Midwest CEPAC 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

Although long-term data on benefits and safety are limited, evidence provides moderate certainty that dupilumab, reslizumab, and benralizumab each provide an equivalent or better net benefit when used as an add-on maintenance treatment to standard of care. Evidence provides high certainty that both omalizumab and mepolizumab provide a small net benefit when added to standard of care. Given the lack of head-to-head clinical trials, or a consistent patient population studied across the placebo-controlled trials, the evidence is insufficient to compare the clinical effectiveness of each treatment to the others.

Patients value that dupilumab may be self-administered at home, while the other four biologic therapies require administration by a health professional. Omalizumab and reslizumab each carry a black box warning for anaphylaxis.

Economic analyses assessing long-term cost-effectiveness found that all five treatments far exceed commonly cited thresholds of $50,000-$150,000 per quality-adjusted life year (QALY) gained: $374,000 per QALY for dupilumab, $325,000 per QALY for omalizumab, $344,000 per QALY for mepolizumab, $391,000 per QALY for reslizumab, and $371,000 per QALY for benralizumab. To align costs with the added benefits for patients, the current net prices of these treatments would need to be discounted between 50% and 79%.

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.