Ocaliva (obeticholic acid) — Medica
Primary biliary cholangitis (also known as primary biliary cirrhosis)
Initial criteria
- age ≥ 18 years
- Diagnosis of primary biliary cholangitis is confirmed by TWO of the following: (a) alkaline phosphatase elevated above upper limit of normal; OR (b) positive anti-mitochondrial antibodies or other PBC-specific autoantibodies (sp100 or gp210) if AMA negative; OR (c) histologic evidence of PBC from liver biopsy
- ONE of the following: (a) receiving ursodiol therapy for ≥ 1 year with inadequate response; OR (b) unable to tolerate ursodiol therapy
- ONE of the following: (a) patient does not have cirrhosis; OR (b) patient has compensated cirrhosis without evidence of portal hypertension (ascites, gastroesophageal varices, or persistent thrombocytopenia)
- Prescribed by or in consultation with a gastroenterologist, hepatologist, or liver transplant physician
Reauthorization criteria
- Patient does not have cirrhosis OR has compensated cirrhosis without evidence of portal hypertension (ascites, gastroesophageal varices, or persistent thrombocytopenia)
- Patient has responded to Ocaliva as determined by the prescriber (e.g., improved biochemical markers such as ALP, bilirubin, GGT, AST, ALT)
Approval duration
Initial: 6 months; Reauthorization: 1 year