Subject: Bosulif SGM 2171-A P2025

Drug

BOSULIF  (bosutinib)

Policy:

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 Indications¹

• Treatment of adult and pediatric 1 years of age and older patients with newly-diagnosed or resistant or intolerant to prior therapy chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML)
• Treatment of adult patients with accelerated phase (AP) or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy

Compendial Uses^2-4

• Primary treatment of patients with advanced phase CML (accelerated phase or blast phase)
• Additional therapy for CML patients after hematopoietic stem cell transplant (HSCT)
• Ph+ B-cell acute lymphoblastic leukemia or lymphoblastic lymphoma (Ph+ B-ALL/LL)
• Maintenance therapy for Ph+ B-ALL/LL patients after HSCT
• Myeloid/lymphoid neoplasms with eosinophilia and ABL1 rearrangement in chronic phase or blast phase

All other indications are considered experimental/investigational and not medically necessary.

Documentation

The following information is necessary to initiate the prior authorization review:

• Prior to initiation of therapy for treatment of CML or Ph+ B-ALL/LL: results of cytogenetic and/or molecular testing for detection of the Ph chromosome or the BCR::ABL gene
• For members requesting initiation of therapy with the requested medication for treatment of CML or Ph+ B-ALL/LL after experiencing resistance to prior tyrosine kinase inhibitor (TKI) therapy: results of BCR::ABL1 mutation testing including T315I, G250E, V299L, F317L mutations
• For members requesting initiation of therapy with the requested medication for treatment of myeloid and/or lymphoid neoplasms with eosinophilia: results of testing or analysis confirming ABL1 rearrangement

Coverage Criteria

Chronic Myeloid Leukemia (CML)^1-3

Authorization of 7 months may be granted for treatment of CML that has been confirmed by detection of the Ph chromosome or BCR::ABL gene by cytogenetic and/or molecular testing when any of the following criteria are met:

• Member has not received prior therapy with a tyrosine kinase inhibitor (TKI) (e.g., asciminib, dasatinib, imatinib, nilotinib, ponatinib)
• Member experienced toxicity or intolerance to prior therapy with a TKI
• Member experienced resistance to prior therapy with a TKI and results of BCR::ABL1 mutation testing are negative for all of the following: T315I, G250E, V299L, and F317L
• Member has received HSCT for CML and results of BCR::ABL1 mutation testing are negative for all of the following: T315I, G250E, V299L, and F317L

Ph+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)/Lymphoblastic Lymphoma (B-LL)^2,4

Authorization of 12 months may be granted for treatment Ph+ B-ALL/LL that has been confirmed by detection of Ph chromosome or BCR::ABL gene by cytogenetic and/or molecular testing when any of the following criteria are met:

• Member has not received prior therapy with a TKI (e.g., dasatinib, imatinib, nilotinib, ponatinib)
• Member experienced intolerance or toxicity to prior therapy with a TKI
• Member experienced resistance to prior therapy with a TKI and results of BCR::ABL1 mutation testing are negative for all of the following: T315I, G250E, V299L, and F317L
• Member has received HSCT for Ph+ B-ALL/LL and results of BCR::ABL1 mutation testing are negative for all of the following: T315I, G250E, V299L, and F317L

Myeloid/Lymphoid Neoplasms with Eosinophilia²

Authorization of 12 months may be granted for treatment of myeloid and/or lymphoid neoplasms with eosinophilia and ABL1 rearrangement in the chronic phase or blast phase.

Continuation of Therapy

CML

Authorization may be granted for continued treatment of CML that has been confirmed by detection of Ph chromosome or BCR::ABL gene by cytogenetic and/ or molecular testing when either of the following criteria are met:

• Authorization of 12 months may be granted when any of the following criteria is met:
  • BCR::ABL1 is less than or equal to 10% and there is no evidence of disease progression or unacceptable toxicity while on the current regimen for members who have been receiving the requested medication for 6 months or greater
  • Member has received HSCT and there is no evidence of unacceptable toxicity or disease progression while on the current regimen
• Authorization of up to 7 months may be granted when the member has completed less than 6 months of therapy with the requested medication.

Ph+ B-ALL/LL

Authorization of 12 months may be granted for continued treatment of B-ALL/LL when there is no evidence of unacceptable toxicity or disease progression while on the current regimen and either of the following criteria is met:

• Member has Ph+ B-ALL/LL that has been confirmed by detection of Ph chromosome or BCR::ABL gene by cytogenetic and/ or molecular testing
• Member has received HSCT for B-ALL/LL

Myeloid/Lymphoid Neoplasms with Eosinophilia

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Bosulif [package insert]. New York, NY: Pfizer Inc.; December 2024
2. The NCCN Drugs & Biologics Compendium® © 2025 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed March 24, 2025.
3. NCCN Clinical Practice Guidelines in Oncology® Chronic Myeloid Leukemia (Version 3.2025). © 2025 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed March 24, 2025.
4. NCCN Clinical Practice Guidelines in Oncology® Acute Lymphoblastic Leukemia (Version 3.2024). © 2025 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed March 24, 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.

October 12, 2025