The New England Comparative Effectiveness Public Advisory Council (New England CEPAC), a core program of the Institute for Clinical and Economic Review (ICER), is a nationally-recognized community forum. The New England CEPAC convenes three times each 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 health care.
New England CEPAC directly engages clinicians, patients, and payers during public meetings to discuss implications of the evidence for clinical decision-making and coverage policies. Application of evidence takes shape through new medical policies, benefit designs, and patient and clinician tools to improve clinical care and patient outcomes.
All members of the New England CEPAC must meet ICER’s criteria for Conflict of Interest.
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The New England CEPAC will convene to deliberate and vote on evidence presented in ICER's report on obeticholic acid (Intercept Pharmaceuticals, Inc.) for use in PBC and NASH.
Obeticholic acid (OCA) is a novel bile acid analogue that has shown positive effects on biochemical markers of liver function in phase II trials (NCT00550862) and is currently under consideration by the FDA for treatment of primary biliary cholangitis (PBC) after failure of Ursodeoxycholic Acid (UDCA). Primary biliary cholangitis (PBC), which has until recently been called primary biliary cirrhosis, is a rare, chronic, progressive autoimmune liver disease that affects mainly middle-aged women. In the US, up to 130,000 individuals may have PBC.
In January 2015, obeticholic acid also received a breakthrough designation for treatment of non-alcoholic steatohepatitis (NASH) with concomitant liver fibrosis. Interim findings from the phase III trial are not expected to be available until March 2017; however, clinical interest in potential off-label use of obeticholic acid is likely to be great, given the lack of available treatments with liver-specific effects. NASH is form of nonalcoholic fatty liver disease (NAFLD) that can progress to cirrhosis, liver failure, and cancer. NASH is present in about 30 million adults in the US.
Intervention of Interest: Obeticholic Acid (Intercept Pharmaceuticals, Inc.)
Date of Review: July 2016View materials