CurrentUnitedHealthcarePolicy N/A

Bosulif (bosutinib) — Prior Authorization / Coverage Criteria

Prior authorization and notification criteria for coverage of Bosulif (bosutinib) for UnitedHealthcare members, including pediatric and adult indications for Ph+ CML, Ph+ ALL, and myeloid/lymphoid neoplasms with eosinophilia. Applies to members subject to UnitedHealthcare Pharmacy Clinical Pharmacy Programs.

Policy Summary

PayerUnitedHealthcare

PolicyBosulif (bosutinib) — Prior Authorization / Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2026

Next Review DateFeb 1, 2026

Key ActionSubmit prior authorization requests; approvals are issued for 12 months when diagnostic criteria are met (pediatric <19 auto-approve).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization duration

>=1 yrminimum age

auto-approvepediatric handling

1/2A/2BNCCN categories

Coverage Criteria for Bosulif (bosutinib)

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Patients less than 19 years of age

Covered when ALL of the following are met

Pediatric approval: (1) Patient is less than 19 years of age; (2) Prescription processes automatically without coverage review for members under age 19.

Authorization issued for 12 months for pediatric approvals

Chronic Myelogenous/Myeloid Leukemia

Initial Authorization — Covered when ALL of the following are met

Initial authorization for CML: Diagnosis of chronic myelogenous / myeloid leukemia.

Authorization will be issued for 12 months

Reauthorization for CML: Patient does not show evidence of progressive disease while on Bosulif therapy.

Authorization will be issued for 12 months

Philadelphia chromosome-positive acute lymphoblastic leukemia

Initial Authorization — Covered when ALL of the following are met

Initial authorization for Ph+ ALL: Diagnosis of Philadelphia chromosome-positive acute lymphoblastic leukemia.

Authorization duration follows general policy (typically 12 months)

Reauthorization for Ph+ ALL: Patient does not show evidence of progressive disease while on Bosulif therapy.

Myeloid/lymphoid neoplasms with eosinophilia

Initial Authorization — Covered when ALL of the following are met

Initial authorization for MLN with eosinophilia: (1) Diagnosis of myeloid/lymphoid neoplasms with eosinophilia; (2) Presence of ABL1 rearrangement.

Authorization will be issued for 12 months

Reauthorization for MLN with eosinophilia: Patient does not show evidence of progressive disease while on Bosulif therapy.

NCCN Recommended Regimens

NCCN recognition: Drug recognized by the NCCN Drugs and Biologics Compendium with Category of Evidence and Consensus of 1, 2A, or 2B; supports coverage per criteria above.

Coverage criteria in this policy are the baseline rules for UnitedHealthcare determinations but may be superseded by state or statutory mandates. Some states mandate benefit coverage for off-label use of medications or require use of alternate compendia; where such mandates apply, they take precedence over the language in this document. Providers should be aware that plan-specific benefit language or state law may override these criteria.

Initial Therapy

Initial therapy approvals are diagnosis-specific and issued when diagnosis criteria are met.

Initial approval list: Initial authorization for Bosulif when diagnosis is one of: chronic myelogenous/myeloid leukemia; Philadelphia chromosome-positive acute lymphoblastic leukemia; myeloid/lymphoid neoplasms with eosinophilia with ABL1 rearrangement; or pediatric (<19) patients where prescription processes automatically.

Authorization typically issued for 12 months

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required — approvals issued for 12 months; pediatric processing notes.

Authorization for approved indications (see criteria) will generally be issued for 12 months.
For members under age 19, the prescription will automatically process without a coverage review (pediatric auto-approval).

Step Therapy

Supply Limits and Step Therapy

Supply limits / step therapy may apply. Check benefit plan details for specific quantity limits or required step edits.

Supply limits and/or step therapy may be in place and enforced by program or therapeutic class.
When step therapy is required, prior steps must be met per the member's benefit plan before approval.

Documentation Required

Use of Claims/Medication History and Claim Logic

Prior authorization decisions may be made using prior claims/medication history, diagnosis codes, and automated claim logic.

UnitedHealthcare may approve initial or reauthorization requests based solely on previous claim or medication history, ICD-10 diagnosis codes, and/or claim logic.
Automated approval and re-approval processes vary by program and therapeutic class; providers should include supporting clinical documentation when submitting prior authorization requests to avoid denial or delay.

Note

Coverage Requirements and State/Plan Overrides

Coverage requires meeting the listed criteria; state mandates and specific benefit plan language may supersede.

Coverage is contingent on meeting the applicable clinical criteria in this policy section.
Some states mandate coverage for off‑label medication use or require different compendia; where state mandates apply, they supersede the policy or notification criteria.
Providers should verify member benefit plan specifics and state mandates as they may affect coverage determinations.

Definitions

Ph+ CML definition — Philadelphia chromosome-positive chronic myelogenous leukemia

TermPhiladelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML)

DescriptionChronic myelogenous leukemia characterized by presence of the Philadelphia chromosome (BCR-ABL1 fusion); Bosulif (bosutinib) is indicated for chronic phase Ph+ CML in adults and pediatric patients aged ≥1 year, newly diagnosed or resistant/intolerant to prior therapy.

Key FDA age thresholdIndicated for pediatric patients 1 year of age and older.

Typical authorization durationAuthorization will be issued for 12 months when criteria are met.

NCCN roleNCCN recommends Bosulif in follow-up therapy after other TKIs and in various CML phases and related indications.

Myeloid/lymphoid neoplasms with eosinophilia definition — ABL1 rearrangement description

TermMyeloid/lymphoid neoplasms with eosinophilia with ABL1 rearrangement

DescriptionA group of neoplasms characterized by eosinophilia and the presence of ABL1 gene rearrangement (tyrosine kinase fusion), for which Bosulif is a recommended treatment option.

Coverage requirementInitial authorization requires both: (1) diagnosis of myeloid/lymphoid neoplasms with eosinophilia; AND (2) presence of ABL1 rearrangement.

Reauthorization criterionPatient does not show evidence of progressive disease while on Bosulif therapy.

Authorization durationAuthorization will be issued for 12 months when initial criteria are met.

Background

Bosulif (bosutinib) is a tyrosine kinase inhibitor indicated for treatment of Philadelphia chromosome–positive chronic myelogenous leukemia (Ph+ CML) in adults and pediatric patients 1 year of age and older, including newly diagnosed chronic phase disease as well as disease resistant or intolerant to prior therapy. The agent is also indicated for adults with accelerated or blast phase Ph+ CML with resistance or intolerance to prior therapy, and is recognized in NCCN guidance for use in certain CML and related settings.

Utilization Management Rule	Details
Supply limits and/or step therapy may be in place	UnitedHealthcare may apply supply limits and/or step therapy for Bosulif. This document does not specify particular prior agents or step sequences.
Automated approvals based on claims/medication history	Notwithstanding Coverage Criteria, initial and reauthorization approvals may be issued based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; use of automated processes varies by program.

Policy Summary

PayerUnitedHealthcare

PolicyBosulif (bosutinib) — Prior Authorization / Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2026

Next Review DateFeb 1, 2026

Key ActionSubmit prior authorization requests; approvals are issued for 12 months when diagnostic criteria are met (pediatric <19 auto-approve).

SourceLink

On This Page

OpenPayer

Bosulif (bosutinib) — Prior Authorization / Coverage Criteria

Coverage Criteria for Bosulif (bosutinib)

Initial Therapy

Reauthorization / Continuation Therapy

Provider Actions and Prior Authorization

Definitions

Background

Step Therapy and Quantity Limits

Site of Care