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Livdelzi — Blue Cross Blue Shield of Alabama

primary biliary cholangitis (PBC)

Initial criteria

  • ONE of the following:
  • The requested agent is eligible for continuation of therapy AND ONE of the following:
  • • The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
  • • The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
  • BOTH of the following:
  • • The patient has a diagnosis of primary biliary cholangitis (PBC) AND ALL of the following:
  •  – Diagnosis has been confirmed by at least TWO of the following:
  •   • Biochemical evidence of cholestasis with an alkaline phosphatase (ALP) elevation
  •   • Positive antimitochondrial antibody (AMA) OR positive other PBC-specific autoantibodies (e.g., sp100, gp210) if AMA negative
  •   • Histologic evidence of nonsuppurative cholangitis and destruction of interlobular bile ducts
  •  – Baseline ALP and total bilirubin measured prior to therapy
  •  – ONE of the following:
  •   • BOTH of the following:
  •    – Tried and had inadequate response after ≥1 year of ursodeoxycholic acid (UDCA) (ALP > ULN and/or bilirubin > ULN but < 2× ULN)
  •    – Will continue UDCA in combination with the requested agent
  •   OR
  •   • Has intolerance or hypersensitivity to UDCA
  •   OR
  •   • Has FDA labeled contraindication to UDCA
  •  OR
  • • The patient has another FDA labeled indication for the requested agent
  •  AND if so, ONE of the following:
  •   • Patient's age is within FDA labeling for that indication
  •   OR there is support for use at the patient’s age
  • AND The patient does NOT have decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy)
  • AND Prescriber is a specialist in gastroenterology/hepatology or has consulted such specialist
  • AND Patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

  • Patient has been previously approved for the requested agent through the plan’s prior authorization process
  • AND ONE of the following:
  • • The patient has a diagnosis of PBC AND BOTH of the following:
  •  – ONE of the following:
  •   • Requested agent will be used in combination with UDCA OR
  •   • Patient has intolerance, hypersensitivity, or FDA labeled contraindication to UDCA
  •  – Patient has had clinical benefit with the requested agent as indicated by ALL of the following:
  •   • ALP decrease ≥ 15% from baseline and ALP < ULN
  •   • Total bilirubin ≤ ULN
  • OR
  • • The patient has a diagnosis other than PBC AND has had clinical benefit with the requested agent
  • AND Prescriber is a gastroenterologist/hepatologist or has consulted such specialist
  • AND Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months