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Drug Ocaliva ® (obeticholic acid) [Intercept Pharmaceuticals Inc.]

January 2017

Therapeutic area - Bile Salts

Approval criteria

  • Patient is 18 years of age or older AND
  • Has a diagnosis of primary biliary cholangitis based on 2 of the following:
    • Alkaline phosphatase (ALP) equal or greater than 1.5 times upper limit of normal (ULN) 
    • Presence of antimitochondrial antibodies (AMAS)
    • Histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts AND
  • Has tried an appropriate dosage of ursodeoxycholic acid (UDCA) for at least one year but had an inadequate response OR
  • Has documented contraindication to UDCA AND
  • Obeticholic acid will be prescribed in combination with UDCA, unless contraindication UDCA is documented and provided at time of request

Renewal criteria

  • Chart notes must be supplied at time of request showing patient is responsive to treatment by meeting the following criteria:
    • ALP less than 1.67 times ULN AND
    • Total bilirubin less than or equal to ULN AND
    • ALP decrease of at least 15%

Quantity limits

34 tablets per 34 days

Denial criteria

  • Patients has complete biliary obstruction
  • Patient is prescribed Ocaliva for nonalcoholic steatohepatitis (NASH)

Background information

Ocaliva is FDA-approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.


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