Livdelzi — Blue Cross Blue Shield of Texas

Initial criteria

• Diagnosis of primary biliary cholangitis (PBC) confirmed by at least TWO of the following: biochemical evidence of cholestasis with alkaline phosphatase (ALP) elevation; positive antimitochondrial antibody (AMA) or positive PBC-specific autoantibodies (sp100, gp210) if AMA negative; histologic evidence of nonsuppurative destruction cholangitis and destruction of interlobular bile ducts
• Prescriber has measured baseline alkaline phosphatase (ALP) and total bilirubin prior to therapy
• ONE of the following: BOTH patient tried ≥1 year of ursodeoxycholic acid (UDCA) with inadequate response (ALP > ULN and/or total bilirubin > ULN but < 2× ULN) AND will continue UDCA with the requested agent; OR intolerance or hypersensitivity to UDCA; OR FDA labeled contraindication to UDCA
• If another FDA labeled indication, patient's age must be within FDA labeling OR there is support for use in that age group
• If requested agent is non-preferred, ONE of the following: member type eligible (BCBS IL Fully Insured, ASO Cost/BBF, HIM, Non‑ERISA ASO/Self‑insured Municipalities/Counties); OR patient currently stable on the requested agent; OR tried and had inadequate response to ONE preferred agent; OR discontinued ONE preferred agent for lack of efficacy or adverse event; OR intolerance or hypersensitivity to ONE preferred agent; OR FDA labeled contraindication to ALL preferred agents; OR ONE preferred agent expected ineffective or causes adherence/comorbidity barrier/adverse reaction; OR not in the patient’s best interest based on medical necessity; OR patient tried another same‑class drug discontinued due to lack of efficacy or adverse event
• Patient does NOT have decompensated cirrhosis (ascites, variceal bleeding, hepatic encephalopathy)
• Prescriber is a specialist (gastroenterologist, hepatologist) or has consulted with one
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Length of approval: 12 months
• Alternate approval if: member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND (no FDA labeled contraindications) AND ONE of the following: another FDA labeled indication; another compendia-supported indication; OR prescriber submitted two peer-reviewed journal articles supporting the use (randomized or placebo-controlled trials only)

Approval duration

12 months