CurrentCentenePolicy CP PHAR.565

Asciminib (Scemblix) coverage policy

Defines medical necessity criteria, prior authorization requirements, dosing limits, approved indications (FDA and selected off-label), exclusions (specific resistance/contraindicated mutations), formulation preferences (generic if available), and approval durations for asciminib (Scemblix) across Centene lines of business.

Policy Summary

PayerCentene

PolicyAsciminib (Scemblix) coverage policy

Policy CodePolicy CP PHAR.565

Change TypeMaterial updates and additions

Effective Date03.01.22

Next Review Date

Key ActionProvider must submit supporting documentation (office chart notes, lab results, other clinical information) demonstrating criteria are met.

SourceLink

POLICY UPDATE CHANGES

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

Added coverage criteria for BCR::ABL1-mutated disease (off-label) and myeloid/lymphoid neoplasm with eosinophilia (off-label).

Added exclusions for specific mutations (A337T, P465S/P46SS, M244V, F359V/I/C).

Added new 100 mg tablet strength to product availability.

Dose limits and approval durations clarified for initial and continued therapy.

2FDA-approved indications listed

2Off-label indications with criteria

4Mutations excluded

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6m / 12mApproval durations (initial / continuation)

Coverage Summary

Coverage stance: asciminib (Scemblix) is covered with criteria. The policy defines medical necessity criteria, prior authorization requirements, dosing limits, approved FDA and selected off‑label indications, exclusions for specific mutations, generic preference, and approval durations.

FDA‑approved indications included in coverage: previously treated Ph+ CML in chronic phase (CP) and Ph+ CML in CP with the T315I mutation; the policy was also updated to add the newly diagnosed Ph+ CML in CP indication. Selected off‑label NCCN‑recommended indications are addressed (e.g., CML in accelerated phase and myeloid/lymphoid neoplasm with eosinophilia) with criteria and required documentation.

Exclusions and mutation restrictions: members must not have the following mutations: A337T, P465S (P46SS), M244V, F359V/I/C as listed by the policy per NCCN updates.

Dosing limits and tablet limits: for Ph+ CML without T315I, dose must be ≤ 80 mg per day and ≤ 2 tablets per day; for Ph+ CML with T315I, dose must be ≤ 400 mg per day and ≤ 8 tablets per day. (Policy also documents dosing for T315I in dosage table.)

Approval durations and prior authorization: initial approvals are limited to 6 months; continuation approvals are limited to 12 months (continuation requires documentation of ≥ 30 days on therapy and clinical response). Requests must be prescribed by or in consultation with an oncologist or hematologist and are subject to prior authorization; the provider must submit supporting clinical documentation.

Formulation and prescribing preferences: the policy requires use of generic asciminib, if available, unless contraindicated or clinically significant adverse effects occur. A new 100 mg tablet strength is documented in product availability.

Initial Approval Criteria — Ph+ CML / related

Provider must submit documentation supporting that member has met all approval criteria. Scemblix is medically necessary when ALL of the following are met:

ALL of the following

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 >= 18 years.
Exclusions: Member does NOT have any of the following mutations: A337T, P465S (listed as P46SS in source), M244V, F359V/I/C.

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

Provider must submit documentation supporting that member has met all approval criteria. 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.
Prescribed by or in consultation with an oncologist or hematologist.
Age >= 18 years.
ABL1 rearrangement: Documentation of an ABL1 gene rearrangement.
Dose/supporting evidence:

Continuation Therapy Criteria

Continued Therapy (All Indications listed)

Requirements for continuation of therapy (must meet ALL):

ALL of the following

Prior use: Member is currently receiving medication via Centene benefit; documentation supports that member has received Scemblix for at least 30 days.
Response: Member is responding positively to therapy.
Dose increase limits
- Ph+ CML (no T315I): New dose does not exceed both of the following: 80 mg per day; 2 tablets per day.

Unproven / Exclusions and Off-label Handling

Excluded Mutations / Not-covered scenarios

Exclusions: Member does NOT have any of the following mutations: A337T; P465S (listed as P46SS in source - interpreted as P465S); M244V; F359V/I/C.

Policy lists exclusions for A337T, P46SS (interpreted as P465S), M244V, F359V/I/C per NCCN updates.

Other diagnoses/indications / Non-formulary / Off-label handling

When requested diagnosis/indication is not specifically addressed:

ANY of the following

On-formulary handling: If drug is on formulary/PDL: follow no coverage criteria policy for relevant line of business: CP.CPA.190 (commercial), HIM.PA.33 (health insurance marketplace), CP.PMN.255 (Medicaid).

Applicable Codes

NDC / drug product informationNDC

No codes listed

Provider Actions / Prior Authorization Requirements

Prior Authorization

Prior authorization and prescriber specialty requirement

Requests must be prescribed by or in consultation with an oncologist or hematologist and are subject to prior authorization per Centene processes.

Documentation Required

Submission of clinical documentation

Provider must submit supporting clinical documentation such as office chart notes, laboratory results, and other clinical information demonstrating that the member meets all approval criteria.

Clinical Evidence and Guidelines

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

The brief indicates that specific trial metrics are not provided in the policy summary; recommendations and coverage criteria are based on the prescribing information and NCCN guideline recommendations referenced in the policy and revision history.

Background

Asciminib (Scemblix) is described as a kinase inhibitor indicated for adult patients with previously treated Ph+ CML in chronic phase and Ph+ CML in CP with the T315I mutation; the policy also documents the addition of newly diagnosed Ph+ CML in CP as an FDA‑approved indication.

Indicated and covered populations: adults (Age ≥ 18 years) with Ph+ CML in CP (including specified off‑label coverage for CML in AP and BCR::ABL1‑positive disease per NCCN) and patients with MLNE (myeloid/lymphoid neoplasm with eosinophilia) with documented ABL1 rearrangement when criteria are met.

Centene includes selected off‑label indications per NCCN and requires that off‑label use be supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence). Off‑label requests must be prescribed by or in consultation with an oncologist or hematologist and require submission of clinical documentation.

Additional notes: the policy requires use of generic asciminib if available (unless contraindicated), documents specific excluded mutations (A337T, P46SS/P465S, M244V, F359V/I/C), and records product availability including tablet strengths (20 mg, 40 mg, 100 mg).

Revision History

12.02.24material_addedLatest

RT4: added new FDA-approved indication for newly diagnosed Philadelphia chromosome‑positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP); documented in revision history (approval date 02.25).

1Q 2024material_added

Per NCCN recommendations (1Q 2024 annual review) added coverage criteria for BCR::ABL1‑mutated disease (off‑label) and added coverage criteria for myeloid/lymphoid neoplasm with eosinophilia (off‑label).

1Q 2025

Policy Summary

PayerCentene

PolicyAsciminib (Scemblix) coverage policy

Policy CodePolicy CP PHAR.565

Change TypeMaterial updates and additions

Effective Date03.01.22

Next Review Date

Key ActionProvider must submit supporting documentation (office chart notes, lab results, other clinical information) demonstrating criteria are met.

SourceLink

On This Page

Policy lists exclusions for A337T, P46SS (interpreted as P465S), M244V, F359V/I/C per NCCN updates.

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

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

Dose limits (non-T315I): Dose does not exceed both of the following: 80 mg per day; 2 tablets per day.

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

Regimen evidence: Prescribed regimen must be FDA-approved or recommended by NCCN; off-label use must be supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence).

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 preference: For Scemblix requests, member must use generic asciminib, if available, unless contraindicated or clinically significant adverse effects are experienced.

Regimen evidence: Prescribed regimen must be FDA-approved or recommended by NCCN.

Ph+ CML with T315I: New dose does not exceed both of the following: 400 mg per day; 8 tablets per day.

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

Regimen evidence: Prescribed regimen must be FDA-approved or recommended by NCCN; off-label use must be supported by evidence.

Not on formulary handling: If drug is NOT on formulary/PDL: refer to non-formulary policy for relevant line of business: CP.CPA.190 (commercial), HIM.PA.103 (health insurance marketplace), CP.PMN.16 (Medicaid).

Off-label handling: If requested use is not listed and initial criteria do not apply: refer to off-label use policy for relevant line of business: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), CP.PMN.53 (Medicaid).

Billing Rule

Generic use preference

Member must use generic asciminib (generic Scemblix) if available unless contraindicated or the member experiences clinically significant adverse effects.

Documentation Required

Off-label evidence requirement

For off‑label uses the prescriber must submit supporting evidence (practice guidelines or peer‑reviewed literature) and the prescribed regimen must be FDA‑approved or recommended by NCCN.

Quick eligibility thresholds

Minimum age>= 18 years

Minimum therapy before continuation>= 30 days

Ph+ CML (non-T315I) dosing limit — mg/day<= 80 mg per day

Ph+ CML (non-T315I) dosing limit — tablets/day<= 2 tablets per day

Ph+ CML with T315I dosing limit — mg/day<= 400 mg per day

Ph+ CML with T315I dosing limit — tablets/day<= 8 tablets per day

1Q 2025 annual review: added criteria for off‑label use for CML in accelerated phase (AP) per NCCN guidelines and added exclusion for the M244V mutation per NCCN.

2022-2025material_added

Exclusions added across 2022–2025 reviews per NCCN: contraindicated/excluded mutations include A337T, P46SS (interpreted as P465S), F359V/I/C and later M244V.

07.22.24added

RT4: added new 100 mg tablet strength to product availability.

Policy effective 03.01.22; last review 02.25material_revised

Approval duration and dosing limits clarified: initial approval duration 6 months; continuation approval duration 12 months; dose limits specified (Ph+ CML without T315I: ≤80 mg/day and ≤2 tablets/day; Ph+ CML with T315I: ≤400 mg/day and ≤8 tablets/day).