Subject: Specialty Quantity Limit Ocaliva 2298-H P2023

Drug

OCALIVA  (obeticholic acid)

Policy:

      I.  PROGRAM DESCRIPTION

          The standard limit is designed to allow a quantity sufficient for
          the most common uses of the medication. The recommended
          dosing parameters for the treatment of primary biliary
          cholangitis fall within the standard limits. Coverage of an
          additional quantity may be reviewed on a case-by-case basis
          upon request.


    II.  COVERED QUANTITIES

Medication	Standard Limit	FDA-recommended dosing
Ocaliva (obeticholic   acid) 5 mg tablets	30 per 30 days	Non-cirrhotic or compensated cirrhosis   with no evidence of portal   hypertension: Initial dose   of 5 mg once daily for the first 3   months   After the first 3 months, may increase   to a maximum of 10 mg once daily in   patients who have not achieved an   adequate reduction in alkaline   phosphatase (ALP) and/or total   bilirubin and who are tolerating Ocaliva
Ocaliva (obeticholic   acid) 10 mg tablets

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Ocaliva [package insert]. Morristown, NJ: Intercept Pharmaceuticals, Inc.; May 2022.

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 13, 2023