November 7, 2016– The Institute for Clinical and Economic Review (ICER) has posted a draft scoping document that will shape an upcoming report on treatments for atopic dermatitis, a skin condition sometimes referred to as eczema. ICER’s report will review the evidence on two new and emerging treatments, crisaborole (Pfizer) and dupilumab (Regeneron/Sanofi), to evaluate how effectively these drugs improve symptoms. Analyses in the report will also provide information on the cost-effectiveness and potential short-term budget impact of these new therapies. The draft scoping document will be open to public comment for three weeks until November 29, 2016 at 5pm CT.
The draft scoping document was developed with input from key stakeholders, including relevant patient organizations and clinical experts. For example, patient organizations shared that atopic dermatitis creates symptoms for patients and burdens for patients and families, such as sleep disruption, that may not be well-captured by standard trial outcomes. ICER will continue to engage with patient groups, clinicians, drug manufacturers, and other stakeholders to enrich the evidence available from clinical trials.
This project will evaluate the comparative clinical effectiveness of crisaborole for its expected indication in the treatment of mild-to-moderate atopic dermatitis in children and adults; separately, the report will also evaluate the comparative clinical effectiveness and value of dupilumab for its expected indication in the treatment of moderate-to-severe atopic dermatitis in adults. The report will not compare the clinical effectiveness of crisaborole and dupilumab.
Both drugs are currently under review by the Food and Drug Administration. Approval decisions are expected in January and March of 2017, respectively. The proposed treatments for review are subject to change based on feedback received through public comment and continued discussion with subject matter experts.
All interested stakeholders, including patients, providers, payers, and manufacturers, are encouraged to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered. All comments must be received by November 29, 2016 at 5pm CT. Comments can be submitted by email to email@example.com. More information about submitting a public comment, including formatting specifications, is available on our website. Following the public comment period, a revised scoping document will be posted on or about December 12, 2016.
The Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC) will evaluate the report assessing therapies for atopic dermatitis at a public meeting on May 18, 2017. The Midwest CEPAC is an independent, regional body of practicing physicians, methodological experts, and leaders in patient advocacy and engagement that provides objective, independent guidance on the application of medical evidence to clinical practice and payer policy decisions.
During the May 2017 public meeting, the Council will vote on key questions raised in the report, and a policy roundtable of patient, clinical, payer, and policy experts will discuss recommendations for how best to apply the evidence to policy and practice.
Additional information regarding the report and meeting are available on ICER’s website.
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.