Subject: Specialty Quantity Limit Brukinsa 3413-H P2025a

Drug

BRUKINSA  (zanubrutinib)

Policy:

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.

Covered Quantities

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

Medication	Standard Limit	Exception Limit
Brukinsa (zanubrutinib) 80 mg capsules	120 per 30 days	240 per 30 days
Brukinsa (zanubrutinib) 160 mg tablets	60 per 30 days	120 per 30 days

FDA-Recommended dosing

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.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Brukinsa [package insert]. Winchester, KY: Catalent Pharma Solutions, LLC; June 2025.

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.

11, 2025