Skip to content
The Policy VaultThe Policy Vault

Iqirvo — Blue Cross Blue Shield of Oklahoma

Primary biliary cholangitis (PBC)

Preferred products

  • Iqirvo
  • Ocaliva
  • Livdelzi

Initial criteria

  • Diagnosis of primary biliary cholangitis (PBC) confirmed by at least TWO of the following: (1) biochemical evidence of cholestasis with alkaline phosphatase (ALP) elevation, (2) positive antimitochondrial antibody (AMA) OR positive other PBC-specific autoantibodies (sp100, gp210) if AMA negative, (3) histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts
  • Prescriber has measured the patient’s baseline ALP and total bilirubin prior to therapy with requested agent
  • Patient has tried and had inadequate response after ≥1 year of therapy with ursodeoxycholic acid (UDCA) defined as ALP > ULN and/or total bilirubin > ULN but < 2× ULN AND patient will continue therapy with UDCA in combination with requested agent OR patient has intolerance, hypersensitivity, or FDA labeled contraindication to UDCA
  • If for other FDA labeled indication: patient’s age is within FDA labeling OR there is clinical support for use by age
  • If requested agent is non-preferred, one of the following: (A) request for specified BCBS IL/HIM/ASO group member OR (B) patient currently treated and stable on requested agent OR (C) inadequate response to ONE preferred agent OR (D) discontinued one preferred agent due to lack of efficacy/effectiveness/adverse event OR (E) intolerance/hypersensitivity to ONE preferred agent OR (F) FDA labeled contraindication to ALL preferred agents OR (G) ONE preferred agent expected to be ineffective/unsafe/nonadherent/nonbeneficial based on known characteristics OR (H) preferred agent not in patient’s best interest based on medical necessity OR (I) trial of another drug in same class discontinued due to lack of efficacy/effectiveness/adverse event
  • Patient does NOT have decompensated cirrhosis (ascites, variceal bleeding, hepatic encephalopathy)
  • Prescriber is a gastroenterologist, hepatologist, or has consulted with a specialist in patient’s diagnosis area
  • Patient does NOT have any FDA labeled contraindications to requested agent

Reauthorization criteria

  • Renewal approved when all initial criteria continue to be met (implied by structure of document)

Approval duration

12 months