February 18, 2016 – The Institute for Clinical and Economic Review (ICER) announced today that it will develop a report assessing the comparative clinical effectiveness and value of obeticholic acid (Intercept Pharmaceuticals, Inc.). This drug is currently being considered for approval by the FDA for treatment of the rare liver condition of primary biliary cirrhosis/cholangitis (PBC). It is expected, however, that there will be significant interest in using obeticholic acid for treatment of patients with nonalcoholic steatohepatitis (NASH), a liver condition that can lead to liver failure, now afflicting as many as 3-4% of all Americans. The ICER report on obeticholic acid will be the subject of the July 15, 2016 public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC).
In addition to a systematic review of the comparative clinical effectiveness and cost-effectiveness of obeticholic acid for use in PBC and NASH, ICER’s report will also include value-based price benchmarks that represent price ranges reflective of the comparative benefits of the drug and its affordability for the overall health care system.
The report will form the basis for deliberation and discussion at the public meeting, where the New England CEPAC will vote on the strength of evidence for clinical effectiveness and value, and a policy roundtable of patients, insurers, and clinical experts will discuss how best to apply the evidence to clinical practice and insurance coverage policy.
A draft proposal outlining the scope of the evidence assessment will be posted to the New England CEPAC website for public comment on or about March 23, 2016. After the scoping document is posted, stakeholders will have one week to submit suggestions and refinements to ensure that the report provides a comprehensive analysis of the considerations and issues of greatest importance.
Meeting details and registration information will be posted to the New England CEPAC website as they become available.
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.