ICER report finds Ocaliva an important advance, but too expensive

The US non-profit organization the Institute for Clinical and Economic Review (ICER) has released two Evidence Reports assessing the comparative clinical effectiveness and value of US biopharma Intercept Pharmaceuticals’ (Nasdaq: ICPT) Ocaliva (obeticholic acid; OCA).

One of these examines its use for primary biliary cholangitis (PBC), and the other its use for nonalcoholic steatohepatitis (NASH). Draft versions of these reports were open for a two-week public comment period. The updated Evidence Reports reflect changes based on comments received from patient groups, clinicians, and the manufacturer of the drug.

OCA was recently approved by the FDA for treatment of PBC, a rare autoimmune liver disease that can lead to cirrhosis and ultimately liver failure, under the US Food and Drug Administration’s accelerated program. There is also expected to be significant interest in using OCA for indications beyond those that were part of initial FDA approval, including for treatment of patients with NASH, an obesity-related liver condition that can lead to cancer and liver failure and affects as many as 15 million adults Americans.