Subject: Specialty Quantity Limit Brukinsa 3413-H P2023

Drug

BRUKINSA  (zanubrutinib)

Policy:

      I.  PROGRAM DESCRIPTION

          The standard limit is designed to allow a quantity sufficient for
          the most common uses of the medication. If the member’s plan
          allows a quantity limit exception review for the requested
          medication, coverage of an additional quantity may be provided
          up to the exception limit with prior authorization.

    II.  COVERED QUANTITIES

Medication	Standard Limit	Exception Limit*	FDA-Recommended   dosing
Brukinsa   (zanubrutinib)   80 mg capsules	120 per 30 days	240 per 30 days	Initial dose: 160 mg orally twice daily, or 320 mg orally once daily Concomitant use with moderate CYP3A inducer: 320 mg orally twice daily Dose adjustments are recommended for drug interactions with CYP3A inhibitors/inducers, hepatic impairment, and for adverse reactions.

  * Coverage up to the exception limits may be provided with prior authorization via the Specialty Post Limit
  Quantity Exception Criteria for approval.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Brukinsa [package insert]. San Mateo, CA: BeiGene USA, Inc.; April 2023.

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 31, 2023