CurrentUnitedHealthcarePolicy 2025 P 1012-15

Bosulif (bosutinib) prior authorization/notification policy

UnitedHealthcare prior authorization/notification policy specifying clinical coverage criteria, authorization durations, pediatric auto-approval, and reauthorization requirements for Bosulif (bosutinib) for CML, Ph+ ALL, myeloid/lymphoid neoplasms with eosinophilia and other NCCN-recognized regimens. Effective for commercial pharmacy clinical program.

Policy Summary

PayerUnitedHealthcare

PolicyBosulif (bosutinib) prior authorization/notification policy

Policy CodePolicy 2025 P 1012-15

Change TypeClarified (annual review, no coverage changes)

Effective DateMay 1, 2025

Next Review Date

Key ActionObtain prior authorization/notification; members under age 19 auto-process without coverage review and approvals are issued for 12 months when criteria are met.

POLICY UPDATE CHANGES

Annual review 2/2025 with no changes to coverage criteria; updated background and references.

4Covered Indications (listed)

12 moAuthorization duration

≤19Pediatric auto-approval rule

Coverage Summary

Coverage stance: Covered with criteria. Scope: UnitedHealthcare prior authorization/notification policy for Bosulif (bosutinib) for commercial pharmacy clinical program covering CML, Ph+ ALL, myeloid/lymphoid neoplasms with eosinophilia and other NCCN-recognized regimens. Effective date: 5/1/2025. Authorization duration when criteria met: 12 months. Covered indications listed in the policy: 4. Pediatric auto-approval: prescriptions for members aged ≤19 years will automatically process without a coverage review. Background: Bosulif is FDA-indicated for adult and pediatric patients ≥1 year with chronic phase Ph+ CML (newly diagnosed or resistant/intolerant) and for adults with accelerated or blast phase Ph+ CML resistant/intolerant to prior therapy.

Initial Therapy Criteria

Patients less than 19 years of age

Authorization will be issued for 12 months.

Patient is less than 19 years of age

Prescriptions for members under the age of 19 will automatically process without a coverage review (auto-process without coverage review).

Chronic Myelogenous/Myeloid Leukemia - Initial Authorization

Diagnosis of chronic myelogenous / myeloid leukemia

Myeloid/lymphoid neoplasms with eosinophilia - Initial Authorization

Authorization will be issued for 12 months.

Diagnosis of myeloid/lymphoid neoplasms with eosinophilia

Presence of ABL1 rearrangement

Patients less than 19 years of age (pediatric auto-approval)

Pediatric auto-approval rule: Patient is less than 19 years of age

Prescriptions for members under 19 years of age will automatically process without a coverage review (auto-process without coverage review).

NCCN Recommended Regimens

Authorization will be issued for 12 months.

NCCN recognized: Drug has been recognized for treatment of the cancer indication by The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Continuation / Reauthorization Criteria

Chronic Myelogenous/Myeloid Leukemia - Reauthorization

Authorization will be issued for 12 months.

Patient does not show evidence of progressive disease while on Bosulif therapy

Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) - Reauthorization

Patient does not show evidence of progressive disease while on Bosulif therapy

Provider Actions & Administrative Requirements

Prior Authorization

Prior authorization required

Bosulif requires prior authorization/notification per UnitedHealthcare Pharmacy Clinical Pharmacy Programs; members under age 19 auto-process without coverage review. Authorization will be issued for 12 months when criteria are met.

Documentation Required

Diagnosis documentation required

Providers must document the applicable diagnosis (e.g., chronic myelogenous/myeloid leukemia, Ph+ ALL, myeloid/lymphoid neoplasms with eosinophilia with ABL1 rearrangement) and evidence of non-progression for reauthorization.

Billing Rule

State mandates and benefit plan limitations

State mandates or member-specific benefit plan coverage and other policies/utilization management programs may supersede or impact coverage; some states may mandate off-label coverage or alternative compendia.

Billing Rule

Automated approvals may be used

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; supply limits and/or step therapy may be in place.

Policy number: 2025 P 1012-15. Payer: UnitedHealthcare. Scope: Commercial pharmacy clinical program prior authorization/notification for Bosulif (bosutinib).

Background

Bosulif (bosutinib) is a kinase inhibitor indicated for adult and pediatric patients aged 1 year and older with chronic phase Philadelphia-positive chronic myelogenous leukemia (Ph+ CML), newly diagnosed or resistant/intolerant to prior therapy, and for adult patients with accelerated or blast phase Ph+ CML resistant or intolerant to prior therapy. The NCCN recommends Bosulif in various CML settings (including follow-up therapy after other TKIs, primary treatment in accelerated phase, combinations for blast phase, maintenance and post-transplant relapse management), for Philadelphia-positive acute lymphoblastic leukemia, and for myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase fusion genes. The policy addresses use in both adult and pediatric populations (patients ≥1 year).

Definition — Auto-process without coverage review: prescriptions for members under the age of 19 will automatically process without a coverage review.

Policy Summary

PayerUnitedHealthcare

PolicyBosulif (bosutinib) prior authorization/notification policy

Policy CodePolicy 2025 P 1012-15

Change TypeClarified (annual review, no coverage changes)

Effective DateMay 1, 2025

Next Review Date

Key ActionObtain prior authorization/notification; members under age 19 auto-process without coverage review and approvals are issued for 12 months when criteria are met.

On This Page

OpenPayer

Bosulif (bosutinib) prior authorization/notification policy

Coverage Summary

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Unproven Indications / Exclusions

Applicable Codes

Provider Actions & Administrative Requirements

Clinical Evidence & References

Background

Revision History