ICER Cancels Public Meeting for Non-Alcoholic Steatohepatitis Assessment

— August 2020 Public Meeting Cancelled; Evidence Report Being Posted on July 21, 2020 —
BOSTON, July 1, 2020 – The Institute for Clinical and Economic Review (ICER) announced today that it will not hold the August 2020 Midwest CEPAC public meeting to discuss the comparative clinical effectiveness and value assessment of obeticholic acid for the treatment of non-alcoholic steatohepatitis (NASH). This decision is the result of the Food and Drug Administration recently issuing a Complete Response Letter to Intercept Pharmaceuticals, stating that the current efficacy and safety data was insufficient to support accelerated approval.
ICER is currently finalizing its revised Evidence Report on obeticholic acid, which we still plan to publish on July 21, 2020. The full timeline of past materials for this assessment is available here.
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.