CurrentHealth NetPolicy CP PHAR.565

Clinical Policy: Asciminib (Scemblix)

Clinical coverage policy for asciminib (Scemblix) defining initial and continued therapy criteria for FDA-approved and certain off-label indications (Ph+ CML in CP, Ph+ CML with T315I mutation, newly diagnosed Ph+ CML in CP, CML in accelerated phase off‑label, and myeloid/lymphoid neoplasm with eosinophilia), dosing limits, mutation exclusions, generic-first requirement, and approval durations for Centene-affiliated health plans across Commercial, HIM and Medicaid lines.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Asciminib (Scemblix)

Policy CodePolicy CP PHAR.565

Change TypeAdded indication(s) and off‑label criteriaupdated exclusions and strengths

Effective Date03.01.22

Next Review Date

Key ActionProvider must submit office chart notes, lab results, or other clinical information supporting that member meets all approval criteria and, for off‑label uses, submit practice guideline or peer‑reviewed literature support.

SourceLink

POLICY UPDATE CHANGES

RT4: added new 100 mg tablet strength.

Added FDA‑approved indication for newly diagnosed Ph+ CML in CP.

Added off‑label coverage criteria for CML in accelerated phase and for myeloid/lymphoid neoplasm with eosinophilia (MLNE).

Added exclusions for specific mutations including M244V and others per NCCN.

3Covered Indications (listed)

4Excluded Mutations listed

6 moInitial approval duration

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12 moContinued approval duration

Coverage Summary

Scope: This policy covers asciminib (Scemblix) for FDA‑approved and select NCCN‑supported off‑label indications for adults (≥ 18 years) across Commercial, HIM and Medicaid lines. Covered indications include: FDA‑approved uses — newly diagnosed Philadelphia chromosome‑positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated Ph+ CML in CP, and Ph+ CML in CP with the T315I mutation — and NCCN‑supported off‑label uses such as Ph+ CML in accelerated phase (AP) and myeloid/lymphoid neoplasm with eosinophilia (MLNE) with documented ABL1 rearrangement. (Policy identifier: CP PHAR.565.)

Coverage stance and key limits: The policy is covered with criteria. Pertinent limits and requirements: members must be ≥ 18 years; providers must be or consult with an oncologist/hematologist; for CML in AP prior treatment with ≥ two TKIs is required. Mutation exclusions disallow use in members with listed contraindicated mutations (e.g., A337T, P46SS, M244V, F359 variants) and prescribers must document mutation status. Dosing limits: for Ph+ CML without T315I the request must be ≤ 80 mg per day AND ≤ 2 tablets per day; for Ph+ CML with T315I the request must be ≤ 400 mg per day AND ≤ 8 tablets per day. The policy requires use of generic asciminib when available unless contraindicated. Initial approvals are for 6 months and continued therapy approvals for 12 months (with continued‑therapy baseline of ≥ 30 days of prior therapy and demonstrated response).

Thresholds

Minimum treatment duration prior to continued therapy evaluation≥ 30 days

Age≥ 18 years

Dose limit Ph+ CML (no T315I)≤ 80 mg per day AND ≤ 2 tablets per day

Dose limit Ph+ CML with T315I mutation≤ 400 mg per day AND ≤ 8 tablets per day

Initial Therapy Criteria — Ph+ CML and Related Indications

Initial Approval Criteria - Ph+ CML and related indications

Scemblix is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of one of the following:
- Ph+ CML in chronic phase (CP)
- Ph+ CML in accelerated phase (AP) (off-label)
- BCR::ABL1-positive CML in CP or AP (off-label)
Prescriber specialty: Prescribed by or in consultation with an oncologist or hematologist

Initial Therapy Criteria — Myeloid/Lymphoid Neoplasm with Eosinophilia (MLNE)

Initial Approval Criteria - Myeloid/Lymphoid Neoplasm with Eosinophilia (MLNE)

Scemblix is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of a myeloid/lymphoid neoplasm with eosinophilia (MLNE) in chronic phase or blast phase
Age ≥ 18 years
Prescriber specialty: Prescribed by or in consultation with an oncologist or hematologist
Genetic documentation: Documentation of an ABL1 gene rearrangement

Continuation Therapy Criteria

Continued Therapy (All Indications in Section II)

All indications in Section II must meet all criteria:

ALL of the following

Prior exposure: Member is currently receiving medication via Centene benefit and documentation supports member has received Scemblix for at least 30 days
Clinical response: Member is responding positively to therapy
Dose increase constraints: If request is for a dose increase, new dose must meet dosing limits
Dose limits for Ph+ CML (without T315I):

Unapproved Indications / Exclusions

Diagnoses/Indications Not Authorized

ALL of the following

Not authorized indications: Non-FDA approved indications not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety per off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents
Mutation exclusions: Do not approve for members with excluded mutations: A337T, P46SS (document lists alternate notations), M244V, F359V/I/C; provider must document mutation status
Source mutation notation is inconsistent across document versions and revision history

Applicable Codes

Reference number / policy identifiermixed

CP PHAR.565

Health Net reference number for Asciminib (Scemblix) clinical policy

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior authorization required

Scemblix requires review per this clinical policy; initial approvals are granted for 6 months and continued therapy approvals for 12 months.

Documentation Required

Submit supporting documentation

Provider must submit office chart notes, lab results, or other clinical information supporting that the member meets all approval criteria. For off-label uses, the prescriber must also submit supporting practice guideline or peer‑reviewed literature evidence.

Clinical Evidence & Definitions

Primary evidence sources cited by the policy are the Scemblix Prescribing Information, Novartis, October 2024 and NCCN guidance documents (Chronic Myeloid Leukemia and Myeloid/Lymphoid Neoplasms with Eosinophilia, 2024/2025).

The policy integrates the FDA label (including the T315I indication and dosing limits) and incorporates NCCN‑supported off‑label recommendations (for CML in AP and MLNE) and NCCN‑driven mutation exclusions; practice guideline or peer‑reviewed literature may be required to support other off‑label uses.

Term	Definition
AP	accelerated phase
CP	chronic phase
CML	chronic myeloid leukemia
MLNE	myeloid/lymphoid neoplasm with eosinophilia
TKI	tyrosine kinase inhibitor

Revision History

2024-07-22added

Added new 100 mg tablet strength (RT4: added new 100 mg tablet strength).

2025-02-25addedLatest

Added FDA‑approved indication for newly diagnosed Philadelphia chromosome‑positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).

2025-01-01added

Policy Summary

PayerHealth Net

PolicyClinical Policy: Asciminib (Scemblix)

Policy CodePolicy CP PHAR.565

Change TypeAdded indication(s) and off‑label criteriaupdated exclusions and strengths

Effective Date03.01.22

Next Review Date

SourceLink

On This Page

Prior TKI for CML in AP (off-label): For members with CML in AP: member has had previous treatment with two or more TKIs (e.g., imatinib, bosutinib, ponatinib, dasatinib, nilotinib)

Applies specifically to CML in AP off-label indication

Mutation exclusions: Member does not have any of the following mutations: A337T, P46SS (document lists 'P46SS'), M244V, F359V/I/C (document lists 'O1 F359VIIC')

Source mutation notation is inconsistent across document versions; exclusions are listed in policy text and revision history

Generic-first requirement: For Scemblix requests, member must use generic asciminib, if available, unless contraindicated or clinically significant adverse effects are experienced

Dose limits for Ph+ CML (without T315I): Dose does not exceed both of the following: 80 mg per day AND 2 tablets per day

Dose limits for Ph+ CML with T315I mutation: For Ph+ CML with the T315I mutation: dose does not exceed both of the following: 400 mg per day AND 8 tablets per day

Regimen support for off-label use: Prescribed regimen must be FDA-approved or recommended by NCCN; for off-label use prescriber must submit supporting practice guideline or peer-reviewed literature evidence

Dose support: Dose is within FDA maximum limit for any FDA-approved indication OR is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Generic-first requirement: For Scemblix requests, member must use generic asciminib, if available, unless contraindicated or clinically significant adverse effects are experienced

For Ph+ CML (without T315I): new dose does not exceed both of the following: 80 mg per day AND 2 tablets per day

Dose limits for Ph+ CML with T315I mutation: For Ph+ CML with T315I mutation: new dose does not exceed both of the following: 400 mg per day AND 8 tablets per day

Generic-first requirement: For Scemblix requests, member must use generic asciminib, if available, unless contraindicated or clinically significant adverse effects are experienced

Approval Durations

Initial approval duration6 months

Continued approval duration12 months

Billing Rule

Generic-first requirement

For Scemblix requests, member must use generic asciminib, if available, unless contraindicated or clinically significant adverse effects are experienced. Exceptions are allowed when the generic is contraindicated or causes clinically significant adverse effects.

Documentation Required

Mutation testing and exclusions

Do not approve for members with the excluded mutations listed: A337T, P46SS (P46SS/P465S variant noted in source), M244V, F359V/I/C. The provider must document the members mutation status in the record.

Documentation Required

Specialty prescriber requirement

Prescription must be written by or in consultation with an oncologist or hematologist.

Added off‑label coverage criteria for CML in accelerated phase (AP) and for myeloid/lymphoid neoplasm with eosinophilia (MLNE) per 1Q2025 annual review (per NCCN recommendations).

2023-01-01 to 2025-03-01addedLatest

Exclusions updated across 1Q2023, 1Q2024, and 1Q2025 reviews; added contraindicated/excluded mutations including A337T, P46SS (P46SS listed in source), F359 variants, and M244V per NCCN guidance.