-Report analyzes evidence on the comparative effectiveness of dupilumab, finds price well-aligned with added value for patients; recommendations highlight coverage considerations and actions for all stakeholders to improve evidence, ensure appropriate access, and manage affordability-

Boston, Mass., June 8, 2017– The Institute of Clinical and Economic Review (ICER) has issued a Final Evidence Report and summary of a public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC) that concludes that dupilumab (Dupixent®, Regeneron and Sanofi) offers good long-term value for patients with moderate-to-severe atopic dermatitis.

The report, along with an accompanying Report-at-a-Glance, also assesses the comparative clinical effectiveness of crisaborole (Eucrisa, Pfizer) for mild-to-moderate disease.

“Our analyses showed that dupilumab offers important clinical benefit for patients with moderate-to-severe atopic dermatitis. Moreover, the drug was priced in a way that aligns well with the benefit it provides to patients,” noted David Rind, MD, MSc, ICER’s Chief Medical Officer.

 “We hope our report and recommendations can be a starting point for conversations among patient groups, payers, clinicians, and manufacturers, especially related to potential challenges with affordability, to ensure that those patients who can benefit from treatment with dupilumab are able to access it.”

In developing this report, ICER worked with the National Eczema Association (NEA) to gain insights into the experiences of patients living with atopic dermatitis. These insights contributed immensely to the development of the report.

“Serving the atopic dermatitis community is the core mission of the National Eczema Association, and we were gratified to have such proactive engagement from ICER throughout this process, to ensure that the impact of the disease on patient quality of life was captured in the review,” noted Tim Smith, Vice President of Advocacy and Access at the NEA.

“ICER contacted us early on to learn more about the patient experience and perceptions of value, and we see our contributions, and those of the patients dealing with this disease, reflected throughout the report. We’ve enjoyed working with ICER and hope to see the report being used to support patient access to this important new therapy.”

Comparative Clinical Effectiveness and Value

During the public meeting, the Midwest CEPAC voted that evidence was not adequate to assess the net health benefit of crisaborole compared to topical corticosteroids and topical calcineurin inhibitors. The Council voted that evidence shows dupilumab to be superior to treatment with non-pharmacologic interventions or with cyclosporine for adults with moderate-to-severe atopic dermatitis for whom topical therapies have not been effective.

Turning to value, 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.

Policy Recommendations

The Council also discussed policy implications of the evidence votes with a panel of subject-matter experts, including patients with atopic dermatitis, clinical experts, a drug manufacturer representative, and payer representatives. Among the key implications are:

  • The broad range of severity in atopic dermatitis, limited long-term data on dupilumab’s efficacy and appropriate use, and issues with affordability will likely lead payers to design evidence-based pre-authorization coverage criteria. The policy roundtable identified several key criteria for consideration, including recommendations on specialist prescribing, definition of severity levels, trials of other therapies, stopping rules, and guidance for use of dupilumab in children.
  • Researchers, clinicians, manufacturers, and patient groups should promote standardized measures of severity and of outcomes.
  • Specialty societies should educate members on the appropriate use of new medications for atopic dermatitis.
  • Clinicians and patient groups should appropriately communicate the potential risks of new treatments.
  • Manufacturers and researchers should perform direct comparisons of therapies when appropriate.
  • Policymakers, payers, clinical experts, patient groups, and the manufacturer should continue to explore ways that any potential concern about affordability can be managed so that access to this treatment can be maintained in a sustainable manner.

For the full list of key policy implications, along with more in-depth descriptions, please see ICER’s full report.

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.