Ocaliva — Blue Cross Blue Shield of Illinois

Initial criteria

• 1. ONE of the following:
• A. The patient has a diagnosis of primary biliary cholangitis (PBC) AND ALL of the following:
• 1. Diagnosis confirmed by at least TWO of the following:
• A. Biochemical evidence of cholestasis with alkaline phosphatase (ALP) elevation
• B. ONE of the following: Positive antimitochondrial antibody (AMA) OR positive other PBC-specific autoantibodies (sp100, gp210) if AMA is negative
• C. Histologic evidence of nonsuppurative destruction cholangitis and destruction of interlobular bile ducts
• 2. Prescriber has measured patient's baseline ALP and total bilirubin levels before therapy
• 3. ONE of the following:
• A. BOTH of the following: (1) Tried and had inadequate response after ≥1 year of therapy with ursodeoxycholic acid (UDCA), defined as ALP>ULN and/or total bilirubin>ULN but <2xULN; AND (2) Will continue therapy with UDCA in combination with the requested agent
• B. Intolerance or hypersensitivity to UDCA
• C. FDA labeled contraindication to UDCA
• B. The patient has another FDA labeled indication for the requested agent AND
• 2. ONE of the following:
• A. Patient's age is within FDA labeling for the indication OR
• B. There is support for using the agent at the patient's age for the indication
• 3. If the requested agent is a non-preferred agent, ONE of the following:
• A. Request is for BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR
• B. Patient currently treated and stable on the requested agent [chart notes required] OR
• C. Tried and had inadequate response to ONE preferred agent [chart notes required] OR
• D. ONE preferred agent discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR
• E. Intolerance or hypersensitivity to ONE preferred agent [chart notes required] OR
• F. FDA labeled contraindication to ALL preferred agents [chart notes required] OR
• G. ONE preferred agent expected to be ineffective, cause adherence barrier, worsen comorbid condition, decrease functional ability, or cause adverse reaction [chart notes required] OR
• H. ONE preferred agent not in best interest based on medical necessity [chart notes required] OR
• I. Patient tried another prescription drug in same class as ONE preferred agent and discontinued due to lack of efficacy or adverse event [chart notes required]
• 4. Patient does NOT have decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy)
• 5. Prescriber is specialist (gastroenterologist, hepatologist) or has consulted with one
• 6. Patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• Renewal criteria present in next page (see next chunk for continuation).

Approval duration

12 months