Subject: Specialty Quantity Limit Bosulif 1720-H P2025

Drug

BOSULIF  (bosutinib)

Policy:

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 all FDA-approved indications fall within the standard limits. Coverage of an additional quantity may be reviewed on a case-by-case basis upon request.

Covered Quantities

Medication	Standard Limit
Bosulif (bosutinib) 50 mg capsule	30 capsules per 30 days
Bosulif (bosutinib) 100 mg capsule	300 capsules per 30 days
Bosulif (bosutinib) 100 mg tablet	90 tablets per 30 days
Bosulif (bosutinib) 400 mg tablet	30 tablets per 30 days
Bosulif (bosutinib) 500 mg tablet	30 tablets per 30 days

FDA-recommended Dosing

Ph+: Philadelphia chromosome-positive; CML: chronic myelogenous leukemia

The maximum dose in pediatric and adult patients is 600 mg once daily.

Dose adjustments may be necessary for response, adverse reactions, renal impairment, or hepatic impairment.

Adult newly-diagnosed chronic phase Ph+ CML

400 mg once daily

Pediatric newly-diagnosed chronic phase Ph+ CML

300 mg/m² once daily

Adult chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy

500 mg once daily

Pediatric chronic phase Ph+ CML with resistance or intolerance to prior therapy

400 mg/m² once daily

Place of Service:

Outpatient

The above policy is based on the following references:

1. Bosulif [package insert]. New York, NY: Pfizer Inc.; December 2024.

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.

October 12, 2025