Limited coverage criteria – obeticholic acid

obeticholic acid

5 mg/10 mg tablet

Initial

For the treatment of primary biliary cholangitis (PBC) when prescribed and a Special Authority request is submitted by a gastroenterologist or hepatologist, in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA, when:

• The patient has a confirmed diagnosis of PBC, defined as positive antimitochondrial antibodies or liver biopsy results consistent with PBC
  
  AND
   
• The patient has received UDCA for a minimum of 12 months and has experienced an inadequate response to UDCA and can benefit from the addition of obeticholic acid.
  An inadequate response is defined as:
  •  alkaline phosphatase (ALP) ≥ 1.67 x upper limit of normal (ULN) and/or
  • bilirubin > ULN and < 2 x ULN and/or
  • evidence of compensated cirrhosis
     
    OR
     
• The patient has experienced documented and unmanageable intolerance to UDCA and may benefit from switching therapy to obeticholic acid

12 months

Renewal

The patient continues to benefit from treatment with obeticholic acid, as evidenced by:

Reduction in ALP level to <1.67 x ULN

OR

15% reduction in the ALP level compared with values before beginning treatment with obeticholic acid

For renewals, a Special Authority request must be submitted by a gastroenterologist or hepatologist

12 months