CurrentHealth NetPolicy CP.PHAR.105

Clinical Policy: Bosutinib (Bosulif)

Defines clinical criteria, prior authorization requirements, and coverage conditions for bosutinib (Bosulif) for commercial, HIM/ICHRA, and Medicaid lines of business for treatment of Ph+ leukemias and certain off-label neoplasms.

Policy Summary

PayerHealth Net

PolicyBosutinib (Bosulif) coverage — Clinical Policy

Policy CodePolicy CP.PHAR.105

Change TypeNo material change

Effective DateOct 1, 2012

Next Review Date

Key ActionPrior authorization required with submission of clinical documentation demonstrating member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

FDA-approved for CP, AP, BPIndications listed

12 monthsApproval duration

600 mg/dayMax adult dose

BSA tiersPediatric dosing

3Tablet strengths

Coverage Criteria for Bosutinib (Bosulif)

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Initial Approval — Chronic Myelogenous Leukemia

Covered when ALL of the following are met:

ALL of the following

Diagnosis of Ph+ (BCR-ABL1-positive) CML
Prescriber: Prescribed by or in consultation with an oncologist or hematologist
Age/Phase
- Age ≥ 1 year with chronic phase (CP) CML
- Age ≥ 18 years with accelerated phase (AP) or blast phase (BP) CML
Mutation exclusion: Member does not have the following mutations: T315I, V299L, G250E, or F317L
Prior therapy or regulatory exception
- Member has contraindication, intolerance, or disease progression on imatinib
- Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E)
Brand vs generic: For brand Bosulif requests, member must use generic bosutinib, if available, unless contraindicated or clinically significant adverse effects are experienced
Dose limits
- For an adult member, dose does not exceed 600 mg per day
- For a pediatric member, dose does not exceed the body surface area (BSA)-based dosing listed in section V
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Indication-specific dosing coverage

Coverage aligned with labeled indications and dosing regimens:

Newly diagnosed Ph+ chronic phase CML: Bosutinib dosing for adults: 400 mg/day PO; maximum 600 mg/day. Pediatric BSA-based dosing tiers apply as listed.

Ph+ CP CML with resistance or intolerance to prior therapy: Adult dosing 500 mg PO QD (maximum 600 mg/day); pediatric BSA-based dosing tiers for resistance/intolerance as listed.

Product availability and approval durations: Oral bosutinib available in tablet and capsule formulations at indicated strengths; prior authorization approvals follow plan-specific durations (see policy history).

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the prescriber provides sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace/ICHRA, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

When state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid provisions take precedence. Providers should refer to the applicable state Medicaid manual for any state‑specific coverage rules that modify or supersede terms of this policy for Medicaid members.

Provider Requirements, Prior Authorization, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization required. Submission of documentation (office chart notes, lab results, or other clinical information) is required to demonstrate that the member meets all approval criteria, including diagnosis, prescribing clinician details, prior therapy history, and dosing/age/BSA as applicable. Failure to submit supporting documentation may result in denial.

Provider must document indication, age/BSA, and prior therapy history as applicable.
Requests without adequate clinical documentation may be denied.

Step Therapy

Step Therapy Requirements

Step therapy requirements: A prior trial of imatinib (or intolerance/contraindication/disease progression on imatinib) is required before approval of bosutinib except where state regulations prohibit oncology step therapy. For Illinois HIM requests (per IL HB 5395, effective 1/1/2026) step therapy requirements do not apply. If request is for a State with regulations against step therapy/redirection in certain oncology settings (see Appendix E), the step may be bypassed.

Applicable when prescribing for CML, ALL (off‑label), and myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase fusion genes.
Prescriber must indicate prior imatinib use or provide documentation of intolerance/contraindication/disease progression.

Step Therapy

State Prohibitions on Step Therapy/Redirection

Step therapy/redirection prohibitions and redirection exceptions: Appendix E lists states where step therapy or redirection for stage 4/advanced/metastatic cancer (or specified oncology settings) is prohibited. When the member’s request is for treatment in those jurisdictions, do not apply step therapy/redirection. Providers should follow jurisdiction-specific rules in Appendix E (examples include FL, GA, IA, IN, LA, MS, NV, OH, OK, PA, TN, TX; see Appendix E for details and any state-specific exceptions).

If a state in Appendix E prohibits step therapy/redirection for the member’s cancer setting, bypass imatinib redirection.
Illinois HIM: IL HB 5395 bypasses step therapy for HIM line of business as of 1/1/2026.
TN and LA contain noted exceptions (see Appendix E) where step therapy may be allowed for AB‑rated generics/interchangeable biosimilars or clinically equivalent products.

Key Definitions

Ph+ CML

DefinitionPhiladelphia chromosome-positive (BCR-ABL1-positive) chronic myelogenous leukemia

FDA indication noteBosulif indicated for adult and pediatric patients ≥1 year with chronic phase (CP) Ph+ CML (newly diagnosed or resistant/intolerant)

Related phasesAlso indicated for adult AP or BP Ph+ CML with resistance or intolerance to prior therapy

Imatinib

Therapeutic alternativeImatinib (Gleevec) listed as preferred therapeutic alternative

Imatinib dosing referenceDosing details for imatinib provided in Appendix B of the policy

Role in step therapyMember must have contraindication/intolerance/disease progression on imatinib or meet step therapy exception to proceed to bosutinib

Ph+ CP CML

Term usagePh+ CP CML = Philadelphia chromosome–positive chronic phase chronic myeloid leukemia (used in dosing tables)

Adult dosing exampleNewly diagnosed adult dosing listed as 400 mg/day PO (see section V)

Maximum adult dose noteMaximum adult dose for Ph+ CP CML referenced as 600 mg/day

Biomarker and Mutation Testing Requirements

BCR-ABL1 (Ph+)

Required biomarkerBCR-ABL1 (Philadelphia chromosome-positive) must be present for covered indications

Applies to indicationsRequired for CML, Ph+ ALL (off-label), and myeloid/lymphoid neoplasms with eosinophilia and TK fusion genes

DocumentationPrescriber must document diagnosis confirming BCR-ABL1 / Ph+ status in prior authorization submission

Mutation testing (T315I, V299L, G250E, F317L)

Required mutation testingTesting for T315I, V299L, G250E, and F317L must be negative for approval

ApplicabilityMutation exclusion applies across CML, Ph+ ALL (off-label), and myeloid/lymphoid neoplasm indications

Prescriber responsibilityPrescriber must include mutation status in submitted clinical documentation for prior authorization

ABL1 rearrangement

Biomarker noteABL1 rearrangement required for myeloid/lymphoid neoplasm with eosinophilia and TK fusion genes indication

ReferenceRequirement added per NCCN Compendium as noted in policy history/updates

Coverage contextPresence of ABL1 rearrangement supports off-label coverage when other criteria (prescriber, prior therapy/step therapy exceptions, dosing) are met

Covered Dosing Regimens and Product Strengths

Indication	Age group	Dosing (daily)	Maximum daily dose
Newly diagnosed Ph+ chronic phase (CP) CML
Adults
400 mg/day PO
600 mg/day
Newly diagnosed Ph+ chronic phase (CP) CML
Pediatrics (BSA-based)
< 0.55 m2 = 150 mg/day; 0.55 to <0.75 m2 = 200 mg/day; 0.75 to 0.9 m2 = 250 mg/day; 0.9 to <1.1 m2 = 300 mg/day; ≥ 1.1 m2 = 400 mg/day
Pediatrics (BSA-based maximums)

Indication	Age group	Dosing (daily)	Maximum daily dose
Ph+ CP CML with resistance or intolerance to prior therapy
Adults
500 mg PO QD
600 mg/day
Ph+ CP CML with resistance or intolerance to prior therapy
Pediatrics (BSA-based)
<0.55 m2 = 200 mg/day; 0.55 to <0.63 m2 = 250 mg/day; 0.63 to <0.75 m2 = 300 mg/day; 0.75 to <0.9 m2 = 350 mg/day; 0.9 to <1.1 m2 = 400 mg/day; ≥1.1 m2 = 500 mg/day
Pediatrics (BSA-based maximums) <0.55 m2 = 300 mg/day; 0.55 to <0.63 m2 = 350 mg/day; 0.63 to <0.75 m2 = 400 mg/day; 0.75 to <0.9 m2 = 450 mg/day; 0.9 to <1.1 m2 = 500 mg/day; ≥1.1 m2 = 600 mg/day

Formulation	Indication / Use	Typical adult daily dose	Available strengths
Oral tablets / capsules
Newly diagnosed Ph+ CP CML
400 mg/day (adult)
Tablets: 100 mg, 400 mg, 500 mg; Capsules: 50 mg, 100 mg
Oral tablets / capsules
Ph+ CP CML with resistance or intolerance to prior therapy
500 mg/day (adult)
Tablets: 100 mg, 400 mg, 500 mg; Capsules: 50 mg, 100 mg