Subject: Ocaliva 2029-A SGM P2024

Drug

OCALIVA  (obeticholic acid)

Policy:

      I.  INDICATIONS

          The indications below including FDA-approved indications and compendial uses are
          considered a covered benefit provided that all the approval criteria are met and the member
          has no exclusions to the prescribed therapy.

          FDA-Approved Indication
          Ocaliva is indicated for the treatment of adult patients with primary biliary cholangitis (PBC):
          •   without cirrhosis or
          •   with compensated cirrhosis who do not have evidence of portal hypertension, either in
              combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA, or as
              monotherapy in patients unable to tolerate UDCA.

          This indication is 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.

          All other indications are considered experimental/investigational and not medically necessary.


    II.  DOCUMENTATION

          Submission of the following information is necessary to initiate the prior authorization review:
          A.  For initial requests: Pretreatment serum alkaline phosphatase (ALP) level
          B.  For continuation of therapy: Current serum alkaline phosphatase (ALP) and/or current total
               bilirubin level


   III.  EXCLUSIONS

          Coverage will not be provided for members with either of the following exclusions:
          A.  Member has decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior
               decompensation event.
          B.  Member has compensated cirrhosis with evidence of portal hypertension (e.g., ascites,
               gastroesophageal varices, persistent thrombocytopenia).


   IV.  CRITERIA FOR INITIAL APPROVAL

          Primary biliary cholangitis (PBC) (previously known as primary biliary cirrhosis)
          Authorization of 6 months may be granted for treatment of PBC in adult members when all of
          the following criteria are met:
          A.  Diagnosis of PBC is confirmed by at least two of the following criteria:
               1.  Biochemical evidence of cholestasis with elevation of alkaline phosphatase (ALP) level
                    for at least 6 months duration.
               2.  Presence of antimitochondrial antibodies (AMA) (titer >1:40 by immunofluorescence or
                    immunoenzymatic reactivity) or PBC-specific antinuclear antibodies (ANA) (e.g., anti-
                    gp210, anti-sp100).
               3.  Histologic evidence of PBC on liver biopsy (e.g., non-suppurative inflammation and
                    destruction of interlobular and septal bile ducts).
          B.  Member has an elevated serum ALP level prior to initiation of therapy with the requested
               drug.
          C.  Member meets either of the following criteria:
               1.  Member has had an inadequate response to at least 12 months of prior therapy with
                    ursodeoxycholic acid (UDCA)/ursodiol and the member will continue concomitant
                    therapy with UDCA/ursodiol.
               2.  Member has an intolerance to UDCA/ursodiol.


    V.  CONTINUATION OF THERAPY

          Authorization of 12 months may be granted for members who have achieved or maintained a
          clinical benefit from Ocaliva therapy (i.e., at least a 15% reduction in ALP level, ALP level less
          than 1.67 times upper limit of normal [ULN], total bilirubin less than or equal to ULN).

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Ocaliva [package insert]. Morristown, NJ: Intercept Pharmaceuticals, Inc.; May 2022.
2. Lindor KD, Bowlus CL, Boyer J, et al. Primary biliary cholangitis: 2018 Practice guidance from the American Association for the study of liver diseases. 2019;69(1):394-419.
3. European Association for the Study of the Liver. EASL clinical practice guidelines: The diagnosis and management of patients with primary biliary cholangitis. J Hepatol. 2017;67(1):145-172.

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

December 04, 2024