ICER Report Recommends Patient Access to Dupilumab for Atopic Dermatitis

The Institute for Clinical and Economic Review (ICER) has issued a report recommending that dupilumab (Dupixent), Regeneron/Sanofi’s recently approved biologic medication, offers good long-term value and important clinical benefit for patients with moderate-to-severe atopic dermatitis and should be financially accessible to patients.

The report notes that atopic dermatitis, a common occurrence in children, can be a burden for patients and their families. The disease can have a significant impact on a person’s quality of life and its aesthetic impact can lead to social stress and isolation. Existing treatments for atopic dermatitis have well-known adverse events and may be of limited use for chronic disease, the report notes. In clinical trials for dupilumab for moderate-to-severe atopic dermatitis the report concluded that consistently across all trials, dupilumab met prespecified targets representing successful outcomes in 30% to 44% of patients, compared with 2% to 12% for placebo. Results were similar with weekly or every-other-week dosing, and in patients treated or not with topical corticosteroids.

ICER issued the report and summary of a May 2017 public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), a nationally recognized community forum that convenes 3 times per year at public meetings to review objective evidence reports and develop recommendations for how stakeholders can apply evidence to improve the quality and value of healthcare. ICER’s report also assessed the comparative clinical effectiveness of crisaborole (Pfizer’s Eucrisa, approved in December 2016) for mild-to-moderate disease. Insight into the patient experience was provided by the National Eczema Association.

During the public meeting, the Midwest CEPAC voted that the evidence was insufficient to assess the net health benefit of crisaborole compared with topical corticosteroid and topical calcineurin inhibitors. The Council voted that the evidence shows dupilumab to be superior to treatment with nonpharmacologic interventions or with cyclosporine for adults with moderate-to-severe atopic dermatitis for whom topical therapies have not been effective. Further, the Council found dupilumab to provide intermediate value for patients with moderate disease, and for a mixed population of patients with moderate-to-severe disease. For patients with severe disease, the Council voted that dupilumab is a high-value treatment.

The following key policy recommendations was the result of a roundtable discussion among experts, including payers, patients with atopic dermatitis, and a representative of a drug manufacturer:

• The broad range of severity in atopic dermatitis, the limited long-term data on the efficacy and appropriate use of dupilumab, and issues with affordability will likely lead payers to require preauthorization coverage criteria. The Council’s policy roundtable identified several key criteria for consideration, including recommendations on specialist prescribing, defining severity levels, trials of other therapies, rules for stopping treatment, and guidance on the use of dupilumab in children so that until pediatric trials are complete, clinicians assessing coverage exceptions for children are expert in the drug’s risks and benefits and the spectrum of atopic dermatitis.
• Standardized measures of severity and outcomes should be promoted by researchers, clinicians, drug makers, and patient groups.
• The potential risks of new treatments should be appropriately communicated to patients.
• Manufacturers and researchers should perform direct comparisons of therapies when appropriate.
• Specialty societies should educate members on the appropriate use of new medications for atopic dermatitis.
• All stakeholders—patients, payers, policymakers, experts, and drug makers—should continue to explore ways to make dupilumab affordable, so that access to this important treatment can be maintained in a sustainable manner.