Ocaliva — Blue Cross Blue Shield of Alabama

primary biliary cholangitis (PBC)

Initial criteria

Diagnosis confirmed by at least TWO of the following: • Biochemical evidence of cholestasis with alkaline phosphatase (ALP) elevation • Presence of antimitochondrial antibody (AMA) titer > 1:80 • If AMA negative or ≤ 1:80, presence of PBC-specific autoantibodies (sp100 or gp210) • Histologic evidence of nonsuppurative destruction cholangitis and destruction of interlobular bile ducts
Prescriber has measured baseline ALP and total bilirubin before therapy
Patient does NOT have cirrhosis OR has compensated cirrhosis with NO evidence of portal hypertension
ONE of the following: • Tried and had inadequate response after ≥ 1 year of therapy with ursodeoxycholic acid (UDCA) (inadequate response = ALP > normal and/or total bilirubin > ULN but < 2× ULN) AND will continue UDCA with requested agent • Intolerance or hypersensitivity to UDCA • FDA-labeled contraindication to UDCA
OR patient has another FDA-labeled indication for the requested agent
For FDA indication: patient age within FDA labeling OR supported for that age
Prescriber is a specialist (e.g., gastroenterologist, hepatologist) or has consulted a specialist
Patient does NOT have any FDA-labeled contraindications to Ocaliva

Previously approved for Ocaliva via plan prior authorization
Patient has primary biliary cholangitis (PBC) and EITHER: • NO cirrhosis OR compensated cirrhosis with NO evidence of portal hypertension
AND ONE of the following: • Used in combination with UDCA • Intolerance or hypersensitivity to UDCA • FDA-labeled contraindication to UDCA
AND patient has shown response: ALP decrease ≥ 15% from baseline and ALP < normal AND total bilirubin ≤ ULN
OR patient has another FDA-labeled indication and has had clinical benefit with Ocaliva
Prescriber is a specialist (e.g., gastroenterologist, hepatologist) or has consulted a specialist
Patient does NOT have any FDA-labeled contraindications to Ocaliva

12 months