CurrentCignaPolicy N/A

Oncology - Bosulif Prior Authorization Policy

Defines Cigna's prior authorization requirements and coverage criteria for Bosulif (bosutinib) for prescription benefit plans, including FDA-approved indications and select evidence-supported uses.

Policy Summary

PayerCigna

PolicyOncology - Bosulif Prior Authorization Policy

Policy CodePolicy N/A

Change TypeExpanded pediatric and adolescent age criteriaadministrative updates

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; approvals are provided for covered indications for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Expanded FDA-labeled indication for Ph+ chronic myelogenous leukemia to include pediatric patients ≥ 1 year of age.

Acute lymphoblastic leukemia age requirement changed from ≥18 years to ≥15 years.

Selected revision and review dates updated through 06/12/2024; policies note capsule formulation added previously.

3covered indications with criteria

1 yrinitial approval duration

≥1 yrmin age — CML

≥15min age — Ph+ ALL

Coverage Criteria

Coverage criteria by indication

Covered when ALL of the following are met for the specified indication(s).

CML (FDA-approved): Approve for 1 year if BOTH: A) patient is >= 1 year of age; AND B) patient has Philadelphia chromosome-positive chronic myeloid leukemia.

FDA-approved indication

Ph+ ALL (supportive evidence): Approve for 1 year if ALL: A) patient is >= 15 years of age; AND B) patient has Philadelphia chromosome-positive acute lymphoblastic leukemia; AND C) patient has tried at least one other tyrosine kinase inhibitor for Philadelphia chromosome-positive acute lymphoblastic leukemia (examples: imatinib, dasatinib).

Other use with supportive evidence per policy

Myeloid/Lymphoid Neoplasms with Eosinophilia (ABL1 rearrangement): Approve for 1 year if BOTH: A) patient is >= 18 years of age; AND B) the tumor has an ABL1 rearrangement.

Policy Summary

PayerCigna

PolicyOncology - Bosulif Prior Authorization Policy

Policy CodePolicy N/A

Change TypeExpanded pediatric and adolescent age criteriaadministrative updates

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; approvals are provided for covered indications for 1 year when criteria are met.

SourceLink

On This Page

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Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Bosulif (bosutinib) prescription benefit coverage. Approvals for covered indications are issued for a duration of 1 year. Determinations depend on the member's specific benefit plan, applicable laws and regulations, and any relevant collateral materials; each request is reviewed on its own merits.

Prior authorization required
Approvals for covered indications: 1 year
Coverage determinations consider benefit plan terms, applicable laws/regulations, and relevant collateral materials

Step Therapy

Step Therapy Requirement for Ph+ ALL

For Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL), Bosulif is subject to a step therapy requirement: the patient must have tried at least one other tyrosine kinase inhibitor (for example, imatinib or dasatinib) prior to approval.

Step therapy applies to Ph+ ALL: trial of ≥1 other TKI (e.g., imatinib, dasatinib) required before Bosulif approval.

Denial Risk

Non‑Covered / Experimental Uses

Requests for Bosulif for any indication not explicitly listed as covered (FDA‑approved indications or other uses with supportive evidence) are considered experimental, investigational, or unproven and will be denied; criteria may be updated as new published data become available.

Non‑listed uses = experimental/investigational; not covered

Covered Regimens

Indication	Regimen / Context	NCCN role
Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL)	Bosulif (bosutinib) used as the TKI component in combination with chemotherapy or corticosteroids for induction; may also be used during consolidation, maintenance, or in relapsed/refractory settings depending on clinical context and prior TKI exposure.	Recommended by NCCN for adults and adolescents (category 2A); lists Bosulif among TKI options (with imatinib, dasatinib, nilotinib, ponatinib).
Chronic myeloid leukemia (Ph+ CML) — chronic, accelerated, or blast phase	Bosulif as a primary TKI regimen for newly diagnosed chronic‑phase disease and as a TKI treatment option in advanced phases or following prior TKIs; specific regimen choice depends on line of therapy and patient risk features.	NCCN: recommended as a 'preferred' primary regimen for newly diagnosed chronic‑phase CML (category 1) and recommended in advanced/blast phases or as an alternative after other TKIs (category 2A).
Myeloid/lymphoid neoplasms with eosinophilia and ABL1 rearrangement	Bosulif can be used as TKI therapy, including in combination with ALL‑ or AML‑type induction chemotherapy followed by allogeneic HSCT when eligible for blast‑phase disease; regimen selection depends on lineage and transplant eligibility.	NCCN: listed as 'other recommended regimens' for ABL1 rearrangements (category 2A) and recommended in combination with induction chemotherapy and HSCT in blast phase (category 2A).

Definitions

Ph+ CML — definition/term

TermPhiladelphia chromosome–positive chronic myelogenous leukemia (Ph+ CML).

Covered patient ageIndication includes adults and pediatric patients ≥ 1 year of age for chronic‑phase newly diagnosed or resistant/intolerant to prior therapy.

Disease phasesIncludes chronic phase (newly diagnosed or resistant/intolerant) and accelerated or blast phase in adults with resistance or intolerance to prior therapy.

Ph+ ALL / ABL1‑rearranged neoplasms — definition/term

TermPhiladelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL) and ABL1‑rearranged neoplasms where TKIs may be used.

Age threshold for Ph+ ALLPatient must be ≥ 15 years of age for Ph+ ALL coverage per policy criteria.

Step therapyFor Ph+ ALL, patient must have tried at least one other tyrosine kinase inhibitor (examples: imatinib or dasatinib) prior to Bosulif approval.

Guideline contextNCCN ALL guidelines recommend Bosulif for Ph+ ALL in induction, consolidation, maintenance, and relapsed/refractory settings (category 2A); TKIs are used in combination with chemotherapy for induction.

Background

Bosulif (bosutinib) is a tyrosine kinase inhibitor (TKI) with activity against BCR-ABL1 and is indicated for Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic, accelerated, or blast phases; guideline sources also describe Bosulif as an option in Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL) and in neoplasms with ABL1 rearrangements. Clinical guidance (NCCN) lists Bosulif as a preferred or recommended TKI in several CML settings and as an option in induction, consolidation, maintenance, or relapsed/refractory contexts for Ph+ ALL, with specific regimen choices dependent on clinical context and prior TKI use.

OpenPayer