Subject: Ocaliva 2029-A SGM P2022

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 any 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 members 18 years of age or older when all of the following criteria are met:
A.   Diagnosis of PBC is confirmed by at least two of the following three 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) (eg, anti-gp210, anti-sp100)
      3.   Histologic evidence of PBC on liver biopsy (eg, 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 at least one of the following requirements:
      1.   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, or
      2.   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 ULN, or total bilirubin less than or equal to ULN).

VI. 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.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Ocaliva [package insert]. New York, NY: Intercept Pharmaceuticals, Inc.; February 2022.
2. Lindor KD, Gershwin E, Poupon R, et al. Primary biliary cirrhosis. 2009;50:291-308.
3. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2017;67:145-172.

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.

August 14, 2022