Livdelzi — Blue Cross Blue Shield of Montana

Initial criteria

• Diagnosis of primary biliary cholangitis (PBC) confirmed by at least TWO of the following: biochemical evidence of cholestasis with an alkaline phosphatase (ALP) elevation; positive presence of antimitochondrial antibody (AMA) OR positive presence of other PBC-specific autoantibodies (e.g., sp100, gp210) if AMA is negative; histologic evidence of nonsuppurative destruction cholangitis and destruction of interlobular bile ducts
• Prescriber has measured baseline alkaline phosphatase (ALP) level and total bilirubin level prior to therapy
• ONE of the following: (A) patient has tried and had an inadequate response after at least 1 year of therapy with ursodeoxycholic acid (UDCA) and will continue therapy with UDCA in combination with the requested agent; OR (B) patient has intolerance or hypersensitivity to UDCA; OR (C) patient has an FDA labeled contraindication to UDCA
• If the patient has another FDA labeled indication for the requested agent, the patient's age must be within FDA labeling or supported for use at that age
• If the requested agent is non-preferred, ONE of the following: (A) request is for a BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member; OR (B) patient is currently stable on requested agent; OR (C) patient has tried and had inadequate response to one preferred agent; OR (D) one preferred agent was discontinued due to lack of efficacy or adverse event; OR (E) patient has intolerance or hypersensitivity to one preferred agent; OR (F) patient has an FDA labeled contraindication to all preferred agents; OR (G) one preferred agent expected ineffective or causes adverse impact on adherence, comorbidities, or function; OR (H) one preferred agent not in best interest based on medical necessity; OR (I) patient has tried another agent in same class as one preferred agent that was discontinued due to lack of efficacy or adverse event
• Patient does NOT have decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy)
• Prescriber is a specialist in gastroenterology or hepatology, or has consulted with one
• Patient does NOT have FDA labeled contraindications to requested agent

Reauthorization criteria

• Target Agent(s) will be approved when all initial criteria continue to be met (criteria to be continued from initial section; renewal text referenced but not detailed in this section)

Approval duration

12 months