Ocaliva (obeticholic acid) — United Healthcare
primary biliary cholangitis
Initial criteria
- Diagnosis of primary biliary cholangitis
- AND one of the following: (1) Patient does not have cirrhosis OR (2) Patient has compensated cirrhosis without evidence of portal hypertension
- AND one of the following: (1) BOTH of the following: (a) Used in combination with ursodeoxycholic acid (e.g., ursodiol) AND (b) Patient has not achieved an adequate response to an appropriate dosage of ursodeoxycholic acid (e.g., ursodiol) after at least 12 consecutive months of therapy OR (2) History of contraindication or intolerance to ursodeoxycholic acid (e.g., ursodiol)
Reauthorization criteria
- Documentation of positive clinical response to Ocaliva therapy
Approval duration
12 months