CurrentUnitedHealthcarePolicy 2025 P 1012-15

Bosulif (bosutinib) prior authorization policy

UnitedHealthcare prior authorization/notification policy for Bosulif (bosutinib) covering indications, initial authorization and reauthorization criteria, duration of approval, and references; applies to commercial pharmacy clinical programs with state mandate exceptions. Pediatric prescriptions (<19) auto-process without coverage review.

Policy Summary

PayerUnitedHealthcare

PolicyBosulif (bosutinib) prior authorization policy

Policy CodePolicy 2025 P 1012-15

Change TypeClarified (annual review, no coverage change)

Effective DateMay 1, 2025

Next Review Date

Key ActionSubmit prior authorization; ensure members meet diagnosis-specific criteria for initial authorization and document absence of progressive disease for reauthorization.

POLICY UPDATE CHANGES

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

4Indication groups with explicit criteria (CML, Ph+ ALL, Myeloid/Lymphoid neoplasms, Pediatric auto-approval)

12Standard authorization duration (months)

NCCNCompendium referenced

Coverage Summary

Policy subject: Bosulif (bosutinib) prior authorization policy. Status: CURRENT. Coverage stance: Covered with criteria. Scope summary: UnitedHealthcare prior authorization/notification policy for Bosulif covering indications, initial authorization and reauthorization criteria, duration of approval, and references; applies to commercial pharmacy clinical programs with state mandate exceptions; pediatric prescriptions (<19 years) auto-process without coverage review. Effective date: 2025-05-01. Last review: 2025-02-01.

Initial Therapy Criteria

Chronic Myelogenous/Myeloid Leukemia (CML) - Initial Authorization

Bosulif will be approved based on the following criterion:

Diagnosis of chronic myelogenous / myeloid leukemia

Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL) - Initial Authorization

Bosulif will be approved based on the following criterion:

Diagnosis of Philadelphia chromosome-positive acute lymphoblastic leukemia

Myeloid/Lymphoid Neoplasms with Eosinophilia and ABL1 rearrangement - Initial Authorization

Bosulif will be approved based on BOTH of the following criteria:

Diagnosis of myeloid/lymphoid neoplasms with eosinophilia

Presence of ABL1 rearrangement

General Pediatric Auto-approval

Covered when ALL of the following are met:

Patient is less than 19 years of age

Prescription will automatically process without a coverage review; authorization issued for 12 months

NCCN Recognized/Other Indications

Coverage may be consistent with NCCN Drugs and Biologics Compendium recommendations:

Use in follow-up therapy in CML after primary treatment with asciminib, imatinib, dasatinib, or nilotinib (per NCCN)

Primary treatment of CML in accelerated phase as a single agent (per NCCN)

Combination regimens for blast phase or lymphoid blast phase or maintenance as described by NCCN

Treatment of Ph+ ALL and other NCCN-recommended conditions including myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase fusion genes

Reauthorization / Continuation Criteria

Chronic Myelogenous/Myeloid Leukemia (CML) - Reauthorization

Bosulif will be approved for reauthorization when ALL of the following are met:

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

Authorization will be issued for 12 months

Ph+ ALL - Reauthorization

Bosulif will be approved for reauthorization when ALL of the following are met:

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

Authorization will be issued for 12 months

Myeloid/Lymphoid Neoplasms with Eosinophilia - Reauthorization

Bosulif will be approved for reauthorization when ALL of the following are met:

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

Authorization will be issued for 12 months

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization/notification applies for Bosulif. Members must meet diagnosis-specific criteria for initial authorization. When criteria are met, authorizations are issued for 12 months. No specific billing or procedure codes are listed in the document.

No specific billing codes listed in the source document

Documentation Required

Documentation of disease status for reauthorization

For reauthorization, the provider must document that the patient does not show evidence of progressive disease while on Bosulif therapy. Reauthorizations are issued for 12 months when this requirement is met.

Billing Rule

Pediatric auto-processing

For members under age 19 years, the prescription will automatically process without a coverage review; when processed in this manner, an authorization will be issued for 12 months.

Leaf: "Prescription will automatically process without a coverage review; authorization issued for 12 months."

Billing Rule

Automated approvals

UnitedHealthcare may approve initial and reauthorization requests based solely on prior claim or medication history, diagnosis codes (ICD-10), and/or claim logic. Use of automated approval and re-approval processes varies by program.

Denial Risk

State mandates may supersede

State-mandated coverage for off-label uses or compendium references may supersede the policy language. Federal regulatory requirements and the member-specific benefit plan coverage may also impact coverage criteria and override the policy.

Background

Background: Bosutinib is a kinase inhibitor indicated for adult and pediatric patients 1 year of age and older with chronic phase Philadelphia-positive chronic myelogenous leukemia (Ph+ CML), newly diagnosed or resistant/intolerant to therapy, and for adult patients with accelerated or blast phase Ph+ CML with resistance or intolerance. The NCCN recommends Bosulif in follow-up therapy in CML after primary treatment with asciminib, imatinib, dasatinib, or nilotinib; as primary treatment of accelerated-phase CML as a single agent; in combination regimens for blast phase or lymphoid blast phase and for maintenance in certain settings; for Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL); and for myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase fusion genes. Typical clinical contexts addressed by the policy include newly diagnosed or resistant/intolerant chronic phase CML, accelerated or blast phase CML, Ph+ ALL, and myeloid/lymphoid neoplasms with eosinophilia.

Definitions and Standard Duration

Auto-processPrescription processes without coverage review for members under age 19.

Progressive diseaseClinical or radiographic evidence indicating disease worsening while on therapy (policy requires no evidence of progressive disease for reauthorization).

Standard authorization durationAuthorization will be issued for 12 months.

Revision History

2014-02-01change_log

Updated coverage criteria to include coverage for post allogeneic HSCT.

2014-09-01change_log

Administrative change: Tried/Failed exemption for State of New Jersey removed.

2015-02-01annual_review

Annual review. Added coverage for Ph+ ALL with mutations.

2016-02-01annual_review

Annual review. Updated background and criteria for NCCN recommendations for expanded CML coverage and removal of tried/failed criteria for ALL; updated references.

2016-12-01annual_review

Annual review. Changed Gleevec to imatinib mesylate; removed ALL from off-label coverage criteria per NCCN; updated background, formatting and references.

2017-11-01annual_review

Annual review. Updated background information and coverage criteria for advanced phase CML and added criteria for relapsed/refractory Ph+ ALL.

2018-02-01update

Per NCCN recommendation: updated references.

2019-02-01annual_review

Annual review. No changes to coverage criteria; updated reference.

2020-02-01annual_review

Annual review. Added general NCCN recommendations for use criteria; updated references.

2021-02-01annual_review

Annual review. Added NCCN recommendations for myeloid/lymphoid neoplasms and updated criteria for Ph+ ALL based on NCCN recommendations.

2022-02-01annual_review

Annual review with no changes to coverage criteria; updated references.

2023-02-01annual_review

Annual review with no changes to coverage criteria; added state mandate footnote and updated references.

2024-02-01annual_review

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

2025-02-01annual_reviewLatest

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

Policy Summary

PayerUnitedHealthcare

PolicyBosulif (bosutinib) prior authorization policy

Policy CodePolicy 2025 P 1012-15

Change TypeClarified (annual review, no coverage change)

Effective DateMay 1, 2025

Next Review Date

Key ActionSubmit prior authorization; ensure members meet diagnosis-specific criteria for initial authorization and document absence of progressive disease for reauthorization.

On This Page

OpenPayer

Bosulif (bosutinib) prior authorization policy

Coverage Summary

Initial Therapy Criteria

Reauthorization / Continuation Criteria

Provider Actions & Authorization Requirements

Applicable Codes

Clinical Evidence & References

Background

Revision History