Ocaliva

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.

Questions?

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