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Livdelzi — Blue Cross Blue Shield of Kansas

Primary biliary cholangitis (PBC)

Initial criteria

  • ONE of the following:
  • A. The requested agent is eligible for continuation of therapy AND ONE of the following: patient has been treated with the requested agent within the past 90 days OR prescriber states patient has been treated with the requested agent within the past 90 days and is at risk if therapy is changed
  • OR
  • B. BOTH of the following:
  • 1. ONE of the following:
  • A. The patient has a diagnosis of primary biliary cholangitis (PBC) AND ALL of the following:
  • • Diagnosis confirmed by at least TWO of: biochemical evidence of cholestasis with alkaline phosphatase (ALP) elevation; positive antimitochondrial antibody (AMA) or other PBC-specific autoantibodies (sp100, gp210) if AMA negative; histologic evidence of nonsuppurative destruction cholangitis and interlobular bile duct destruction
  • • Prescriber has measured patient's baseline ALP and total bilirubin prior to therapy
  • • ONE of the following:
  • A. BOTH: inadequate response after ≥1 year of ursodeoxycholic acid (UDCA) therapy (ALP > ULN and/or total bilirubin > ULN but <2× ULN) AND patient will continue UDCA in combination with requested agent
  • B. Intolerance or hypersensitivity to UDCA
  • C. FDA labeled contraindication to UDCA
  • OR
  • B. The patient has another FDA labeled indication for the requested agent
  • AND
  • • ONE of the following: patient's age within FDA labeling for requested indication OR support for use for patient's age
  • AND
  • The patient does NOT have decompensated cirrhosis (ascites, variceal bleeding, hepatic encephalopathy)
  • AND
  • Prescriber is a gastroenterologist, hepatologist, or has consulted with one
  • AND
  • Patient does NOT have FDA labeled contraindications to the requested agent

Reauthorization criteria

  • Patient previously approved for the requested agent through plan's PA process
  • AND ONE of the following:
  • A. Patient has PBC AND BOTH:
  • • ONE of the following: requested agent will be used with UDCA OR patient has intolerance, hypersensitivity, or FDA labeled contraindication to UDCA
  • • Patient has had clinical benefit with requested agent as indicated by BOTH: ALP decrease ≥15% from baseline and ALP < ULN; total bilirubin ≤ ULN
  • OR
  • B. Patient has diagnosis other than PBC AND has had clinical benefit with requested agent
  • AND
  • Prescriber is a gastroenterologist, hepatologist, or has consulted with one
  • AND
  • Patient does NOT have FDA labeled contraindications to the requested agent

Approval duration

12 months