CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Bosulif (bosutinib) — Coverage Criteria

Defines accepted indications, exclusion criteria, and utilization management requirements for bosutinib (Bosulif) for members whose medication requests are processed by Evolent on behalf of the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBosulif (bosutinib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNov 29, 2024

Next Review DateN/A

Key ActionSubmit prior authorization supporting FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature; continuation may be approved without re-review when no disease progression and prior use within the last year with ≤30-day lapse.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

FDA & select off-labelIndications governed

600 mgDose exclusion threshold

Monthly limitsQuantity limits

UM DeptDecision authority

2024-11-29Policy effective date

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Coverage Criteria

Initial and continuation coverage criteria

Covered when ALL of the following are met (per indication group):

Continuation requests: Member has not experienced disease progression on the requested medication; requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; additional medication(s) are not being added to the continuation request.

From policy continuation rules

Acute Lymphoblastic Leukemia (ALL): Member has Philadelphia chromosome positive or BCR-ABL positive B-Cell ALL; bosutinib may be used as a single agent or in combination with chemotherapy as induction, consolidation, maintenance, or subsequent therapy.

Indication-specific criteria

Chronic Myelogenous Leukemia (CML): Bosutinib may be used in all phases of Philadelphia chromosome positive or BCR-ABL positive CML, including before and after hematopoietic stem cell transplantation as initial or subsequent therapy.

Indication-specific criteria

Requests for Bosulif (bosutinib) will be excluded when any of the following apply: the member has experienced disease progression while taking bosutinib; bosutinib is being used for Philadelphia chromosome–negative or BCR-ABL–negative CML/ALL; for CML, the member has one of the listed resistant mutations (T315I, V299L, G250E, or F317L); dosing exceeds the single dose limit of 600 mg; or treatment exceeds the specified monthly quantity limits (30 tablets of 500 mg, 30 tablets of 400 mg, or 120 tablets of 100 mg per month; 90 capsules of 100 mg or 30 capsules of 50 mg per month).

Investigational or off‑label uses lacking sufficient evidence are also excluded. The policy specifies that case reports and abstracts without full peer‑reviewed publications generally do not provide adequate supportive clinical evidence. Sufficient evidence must align with CMS‑recognized compendia or acceptable peer‑reviewed literature and meet the policy’s criteria for study population representation, regimen relevance, clinically meaningful outcomes (for example ASCO‑recommended thresholds), and appropriate study design.

Use of bosutinib for investigational or off‑label indications is considered not medically necessary unless supported by authoritative sources. Documentation must demonstrate support from CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature that meet the policy’s evidentiary standards (adequate representation of patient and tumor characteristics, appropriate regimen representation, clinically meaningful outcomes, and acceptable study design).

The policy explicitly notes that case reports and meeting abstracts without full peer‑reviewed articles generally do not provide sufficient evidence to establish an accepted use and therefore do not justify coverage for investigational/off‑label indications.

Initial Therapy

Initial therapy

Initial therapy coverage statements provided by indication:

ALL initial/subsequent therapy: Bosutinib may be used as a single agent or in combination with chemotherapy as induction, consolidation, maintenance, or subsequent therapy for Philadelphia chromosome positive or BCR-ABL positive B-Cell ALL.

From INDICATIONS section

CML initial/subsequent therapy: Bosutinib may be used in all phases of Philadelphia chromosome positive or BCR-ABL positive CML, including before and after hematopoietic stem cell transplantation as initial or subsequent therapy.

From INDICATIONS section

Continuation / Renewal Criteria

Continuation therapy

Continuation/renewal criteria when prior authorization exists:

Continuation approval: Member has not experienced disease progression on bosutinib; prior use within the last year without a lapse of more than 30 days of having an active authorization; no additional medication(s) are being added to the continuation request.

Continuation rules from policy

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required for Bosulif (bosutinib). Continuation requests may be approved without full re-review when all continuation conditions are met (no disease progression on the requested medication, prior use within the last year without a lapse >30 days, and no additional medications being added).

Prior authorization required
Continuation may be approved without re-review if no disease progression, prior use within last year with ≤30-day lapse, and no new meds added

Step Therapy

Therapy Sequencing

Bosulif (bosutinib) may be used as initial or subsequent therapy for Philadelphia chromosome positive (Ph+) / BCR‑ABL positive Chronic Myelogenous Leukemia (CML) in all phases, including before and after hematopoietic stem cell transplantation. It may be used as a single agent or in combination with chemotherapy for Philadelphia chromosome positive or BCR‑ABL positive B‑cell Acute Lymphoblastic Leukemia (ALL) as induction, consolidation, maintenance, or subsequent therapy.

Coding & Dose Limits

inv-04: Single dose limit

Single dose limitMaximum single dose of Bosulif (bosutinib) must not exceed 600 mg.

Rationale for denialRequests will be excluded/denied if dosing exceeds single dose limit of 600 mg.

ScopeApplies to all Bosulif (bosutinib) dosing requests under this policy.

inv-05: Monthly tablet/capsule limits

500 mg tabletsLimit: 30 tablets per month.

400 mg tabletsLimit: 30 tablets per month.

100 mg tabletsLimit: 120 tablets per month.

Quantity Limits

inv-15: Bosulif (bosutinib) — Monthly tablet/capsule quantity limits

500 mg tablets (monthly)30 tablets per month.

400 mg tablets (monthly)30 tablets per month.

100 mg tablets (monthly)120 tablets per month.

100 mg capsules (monthly)90 capsules per month.

50 mg capsules (monthly)30 capsules per month.

inv-16: Bosulif (bosutinib) — Single dose limit

Maximum single doseBosulif (bosutinib) single dose must not exceed 600 mg.

Definitions

inv-11: Ph-positive / BCR-ABL-positive disease

DefinitionPh-positive / BCR-ABL–positive disease: leukemias that test positive for the Philadelphia chromosome or the BCR-ABL fusion protein.

Applicable indicationsBosulif may be used for Philadelphia chromosome–positive or BCR-ABL–positive B‑cell ALL as single agent or with chemotherapy for induction, consolidation, maintenance, or subsequent therapy.

Applicable indications (CML)Bosulif may be used in all phases of Philadelphia chromosome–positive or BCR-ABL–positive CML, including before and after hematopoietic stem cell transplantation as initial or subsequent therapy.

Exclusions specific to marker statusUse is excluded when Bosulif is being used for Philadelphia chromosome or BCR‑ABL negative CML/ALL.

Step Therapy

Step	Requirement / Description
1	No explicit step-therapy sequence is required. The policy permits bosutinib (Bosulif) to be used as initial or subsequent therapy for covered indications (Ph‑positive/BCR‑ABL–positive CML in all phases and Ph‑positive/BCR‑ABL–positive B‑cell ALL as single agent or with chemotherapy).

Background

Bosutinib (Bosulif) is a tyrosine kinase inhibitor indicated for leukemias that are Philadelphia chromosome–positive or BCR‑ABL–positive. The policy governs its use across disease settings, including as induction, consolidation, maintenance, or subsequent therapy for Ph+ B‑cell acute lymphoblastic leukemia (ALL) and in all phases of Ph+ or BCR‑ABL+ chronic myelogenous leukemia (CML), and establishes utilization management requirements including prior authorization, continuation rules, mutation‑based exclusions, and dose/quantity limits.

As a reminder, requests are subject to the policy’s exclusion and quantity limits (for example, a maximum single dose of 600 mg and specified monthly tablet/capsule limits) and must be supported by appropriate clinical evidence or compendia per the coverage criteria.