CurrentmhnPolicy CP.PHAR.565

Asciminib (Scemblix) coverage for Ph+ CML and select off-label hematologic neoplasms

Defines medical necessity criteria, dosing limits, documentation and prior authorization requirements for asciminib (Scemblix) for adults with Philadelphia chromosome-positive chronic myeloid leukemia (including newly diagnosed and previously treated), T315I-mutated disease, and select off-label uses (Ph+ B-cell ALL, MLNE). Applies to members served by the payer (commercial, HIM, Medicaid).

Policy Summary

Payermhn

PolicyAsciminib (Scemblix) coverage for Ph+ CML and select off-label hematologic neoplasms

Policy CodePolicy CP.PHAR.565

Change TypeMaterial updates — FDA label expansion, revised TKI requirement, new molecular documentation, added off‑label criteria, authorization duration change

Effective DateMar 1, 2022

Next Review Date

Key ActionSubmit prior authorization with office notes, labs, and documentation of ABL1 exon 2 (when required) showing member meets all criteria.

SourceLink

POLICY UPDATE CHANGES

Added FDA-approved indication for newly diagnosed Ph+ CML in chronic phase (CP).

Changed requirement for TKI-experienced patients from accelerated phase (AP) to chronic phase (CP).

Added requirement for documentation of presence of ABL1 exon 2.

Added off-label coverage criteria for Ph+ B-cell ALL and myeloid/lymphoid neoplasm with eosinophilia (MLNE).

Updated initial and continued authorization durations from 6 months to 12 months.

3FDA-approved indications listed

12 monthsApproval duration

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Coverage Criteria

Initial Therapy — Chronic Myeloid Leukemia

Covered when ALL of the following are met for Initial Approval — Chronic Myeloid Leukemia:

CML initial approval

Diagnosis (one of)
- Ph+ CML in chronic phase (CP).
- Ph+ CML in accelerated phase (AP) (off-label).
- BCR::ABL1-positive CML in CP or AP (off-label).
Prescribed by or in consultation with an oncologist or hematologist.
Age \u2265 18 years.
For members with CML in CP: previous treatment with two or more tyrosine kinase inhibitors (e.g., imatinib, bosutinib, ponatinib, dasatinib, nilotinib).
Member does not have any of the following mutations: A337T, P465S, M244V, or F359V/I/C.
Documentation that the member is not lacking ABL1 exon 2 (e.g., b2(e13)a3, b3(e14)a3 isoforms).
Use generic asciminib (Scemblix) if available unless contraindicated or clinically significant adverse effects are experienced.
Dose/regimen (one of)
- For Ph+ CML (non-T315I): dose does not exceed both i) 80 mg per day and ii) 2 tablets per day.
- For Ph+ CML with the T315I mutation: dose does not exceed both i) 400 mg per day and ii) 8 tablets per day.
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
Prescribed regimen must be FDA-approved or recommended by NCCN.

CML initial approval (operational note): Approval duration: 12 months.

Initial Therapy — Ph+ B-cell ALL (off-label)

Covered when ALL of the following are met for Initial Approval — Ph+ B-cell ALL (off-label):

Ph+ B-cell ALL initial approval (operational note): Approval duration: 12 months.

Initial Therapy — Myeloid/Lymphoid Neoplasm with Eosinophilia (off-label)

Covered when ALL of the following are met for Initial Approval — Myeloid/Lymphoid Neoplasm with Eosinophilia (MLNE) (off-label):

MLNE initial approval (operational note): Approval duration: 12 months.

Requests for uses that are not FDA‑approved and are not specifically addressed in this policy are excluded unless the provider supplies sufficient clinical documentation of efficacy and safety consistent with the payers off‑label use policies. See the off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health insurance marketplace), and CP.PMN.53 (Medicaid) for the type and amount of evidence required to consider coverage for an off‑label indication.

Coverage is not authorized for members who have any of the following ABL1 mutations: A337T, P465S, M244V, or F359V/I/C. These mutation exclusions apply across the covered indications listed in this policy and must be absent in submitted molecular testing documentation for approval.

Continued Therapy

Covered when ALL of the following are met for Continued Therapy (all indications in Section I):

Continued therapy (operational note): Approval duration: 12 months.

Covered Regimens and Dosing

Indication	Dosing / Limits
Ph+ CML (non-T315I)
80 mg PO QD or 40 mg PO BID; maximum 80 mg/day (also must not exceed 2 tablets/day)

Indication	Dosing / Limits
Ph+ CML with T315I mutation
200 mg PO BID; maximum 400 mg/day (also must not exceed 8 tablets/day)

Indication	Dosing Guidance
Ph+ B-cell ALL (off-label)
Use in combination with dasatinib; dose must be within the FDA maximum for any approved indication or supported by practice guidelines/peer‑reviewed literature (prescriber must submit supporting evidence)

Coding

No specific CPT/HCPCS/NDC codes listed in policymixed

No codes listed

inv-08: Max daily dose (Ph+ CML)

Max daily dose80 mg/day (CML dosing: 80 mg PO QD or 40 mg PO BID); maximum 2 tablets/day

Regimen detailDosing regimen documented as 80 mg PO QD or 40 mg PO BID

Tablet limitDo not exceed 2 tablets per day for non-T315I Ph+ CML

inv-09: Max daily dose (Ph+ CML with T315I)

Max daily dose (T315I)400 mg/day (CML with T315I dosing: 200 mg PO BID); maximum 8 tablets/day

Regimen detailDosing regimen documented as 200 mg PO BID for T315I-mutated Ph+ CML

Tablet limit

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must obtain prior authorization and submit documentation that supports the diagnosis, prescriber specialty, patient age, prior TKI exposure (when applicable), mutation testing results, and any other clinical information necessary to demonstrate that the member meets all approval criteria.

Submit office chart notes, relevant lab results, and other clinical documentation to support that the member meets all approval criteria.
Include prescriber specialty (oncologist or hematologist) and patient age.
Document prior TKI exposure details (agents tried, dates, and reasons for discontinuation) when applicable.
Provide mutation testing results (including absence of A337T, P465S, M244V, or F359V/I/C and documentation that ABL1 exon 2 is present) and any other relevant molecular testing.

Step Therapy

Prior TKI Therapy Requirement

For patients with Ph+ chronic phase (CP) CML who are previously treated, prior therapy with two or more tyrosine kinase inhibitors (TKIs) is required. Examples of TKIs include imatinib, bosutinib (Bosulif), ponatinib (Iclusig), dasatinib (Sprycel), and nilotinib (Tasigna). Providers should document prior TKI regimens, durations, and reasons for discontinuation or intolerance.

Line of Therapy

first-line

First-line use: Asciminib is indicated for newly diagnosed Ph+ CML in chronic phase (CP) when FDA approval applies and required documentation is provided.

second-line

Second-line use: For members with previously treated Ph+ CML in chronic phase (CP), requirement: prior treatment with two or more TKIs for eligibility under the previously treated indication.

Biomarker and Mutation Requirements

inv-20: ABL1 gene rearrangement / ABL1 exon 2 presence

RequirementDocumentation of an ABL1 gene rearrangement is required for MLNE (myeloid/lymphoid neoplasm with eosinophilia)

Exon 2 documentationDocumentation that the member is not lacking ABL1 exon 2 (e.g., b2(e13)a3, b3(e14)a3 isoforms) is required for CML criteria

PrescriberPrescribed by or in consultation with an oncologist or hematologist when ABL1 documentation is required

inv-21: Mutations A337T, P465S, M244V, F359V/I/C

Excluded mutationsA337T is listed as an exclusion (member must not have this mutation)

Excluded mutationsP465S is listed as an exclusion (member must not have this mutation)

Background

Asciminib (Scemblix) is a targeted kinase inhibitor indicated for adult patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase, including newly diagnosed and previously treated disease, and for Ph+ CML with the T315I mutation; this policy also provides limited off‑label coverage criteria for relapsed/refractory Ph+ B‑cell acute lymphoblastic leukemia (ALL) and for myeloid/lymphoid neoplasm with eosinophilia (MLNE) when an ABL1 gene rearrangement is documented. Dosing and approval durations differ by indication and mutation status; refer to the dosing limits and documentation requirements in the criteria sections.

Definitions

inv-15: CML — definition entry

TermCML = chronic myeloid leukemia

ContextIncludes Ph+ CML in chronic phase (CP) and accelerated phase (AP) per policy criteria

Age requirementPolicy applies to adults (age ≥ 18 years) with CML when other criteria met

inv-16: CP — chronic phase abbreviation definition

AbbreviationCP = chronic phase

Use in criteriaCML in CP is an FDA‑approved indication for asciminib in this policy

Prior therapy note