Ocaliva — Point32Health
primary biliary cholangitis (PBC)
Initial criteria
- Documented diagnosis of primary biliary cholangitis confirmed by at least two (2) of the following: a. Biochemical evidence of cholestasis with an elevated alkaline phosphatase level for at least a duration of six (6) months b. Presence of antimitochondrial antibodies (titer ≥1:80 by immunofluorescence or M2 positivity by enzyme immunoassay) or primary biliary cholangitis-specific antibodies (e.g., anti-GP210, anti-SP100) c. Histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts on liver biopsy
- Patient age ≥ 18 years
- Prescribed by or in consultation with a gastroenterologist or hepatologist
- Documentation of one (1) of the following: a. The patient has had an inadequate response to at least one (1) year of therapy with ursodeoxycholic acid/ursodiol and the requested drug will be administered in combination with ursodeoxycholic acid/ursodiol OR b. The patient is intolerant to ursodeoxycholic acid/ursodiol
Reauthorization criteria
- Documented diagnosis of primary biliary cholangitis
- Patient age ≥ 18 years
- Prescribed by or in consultation with a gastroenterologist or hepatologist
- Documentation of one (1) of the following: a. The patient has had an inadequate response to at least one (1) year of therapy with ursodeoxycholic acid/ursodiol and the requested drug will be administered in combination with ursodeoxycholic acid/ursodiol OR b. The patient is intolerant to ursodeoxycholic acid/ursodiol
- Documentation the patient has experienced a therapeutic response as defined by a reduction in alkaline phosphatase of at least 15%
Approval duration
initial 6 months; reauth 12 months