CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Scemblix (asciminib) — Coverage Criteria

Defines clinical indications, exclusions, coding, and authorization expectations for coverage of Scemblix (asciminib) for members managed by the payer's utilization management program.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyScemblix (asciminib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective Date12/27/2024

Next Review DateN/A

Key ActionObtain prior authorization with documentation demonstrating an FDA- or guideline-supported indication and that inclusion criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12/27/2024Effective date

12/12/2024Last review

3Pages

2Guideline refs

Coverage criteria for Scemblix (asciminib)

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Continuation requests exemption: The requested medication was used within the last year AND the member has not experienced disease progression and/or no intolerance to the requested medication AND additional medication(s) are not being added to the continuation request.

From policy Section II.A

CML covered indications: Member has Philadelphia chromosome-positive or BCR-ABL positive CML AND (a) adult with newly diagnosed chronic phase OR (b) adult with documented intolerance, contraindication, or disease progression on >=2 TKIs including imatinib AND one of nilotinib or dasatinib OR (c) adult with CML and T315I mutation.

From policy Section II.B

The following situations are exclusions to coverage for Scemblix (asciminib). Coverage will be denied for disease progression while taking asciminib. Scemblix is not covered when used for Philadelphia chromosome–negative or BCR-ABL–negative CML or in members with the specified excluded mutations A337T or P465S.

Dosage and quantity exceedance are exclusionary: requests that exceed the single-dose limits of 80 mg for Ph+ CML or 200 mg for Ph+ CML with the T315I mutation will be denied, as will requests that exceed the monthly maximums of 60 tablets (20 mg), 60 tablets (40 mg), or 120 tablets (100 mg) per month.

Use of Scemblix for indications not supported by the FDA label, CMS‑recognized compendia, NCCN/ASCO guideline recommendations, or acceptable peer‑reviewed literature is considered investigational and will be denied. The policy specifies criteria for what constitutes sufficient evidence, including whether the published evidence adequately represents the patient/cancer population and the therapy regimen, whether outcomes are clinically meaningful (for example, ASCO‑recommended thresholds such as a hazard ratio <0.80 or survival benefits of at least 3 months for OS/PFS), and whether study design is appropriate. Nonrandomized trials with substantial subject numbers may provide supportive evidence, while case reports and meeting abstracts without full articles do not provide adequate support.

Initial therapy criteria

Initial therapy — asciminib

Initial coverage criteria for asciminib

Covered initial indications: Adult member with Philadelphia chromosome-positive or BCR-ABL positive chronic myeloid leukemia who meets ONE of the following: (a) newly diagnosed chronic phase CML; OR (b) documented intolerance, contraindication, or disease progression on >=2 tyrosine kinase inhibitors including imatinib and one of nilotinib (Tasigna) or dasatinib (Sprycel); OR (c) CML with T315I mutation.

Section II.B

Continuation and reauthorization criteria

Continuation therapy exemption

Continuation requests qualifying for exemption from reauthorization

Continuation criteria: Requested medication was used within the last year AND no disease progression and/or no intolerance to the requested medication AND no additional medication(s) are being added to the continuation request.

Section II.A

Provider actions, prior authorization, and denial conditions

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization is required. Requests must include documentation demonstrating an FDA- or guideline-supported indication per policy and evidence meeting inclusion criteria (see criteria for CML and continuation requests).

Authorization processed by Evolent for network ordering providers.
Supportive sources accepted: FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15.

Step Therapy

Prior TKI Requirement

Prior TKI requirement — For most chronic myeloid leukemia (CML) indications, asciminib requires prior intolerance, contraindication, or disease progression on two or more tyrosine kinase inhibitors (TKIs), including generic imatinib and at least one of nilotinib (Tasigna) or dasatinib (Sprycel), except where specified (e.g., newly diagnosed CP CML or T315I mutation).

Applicable to adult members with Ph+ / BCR-ABL+ CML when not newly diagnosed and not T315I mutation indication.
Newly diagnosed chronic phase (CP) adults and adults with documented T315I mutation are separate indications that do not require prior 2-TKI failure.

Documentation Required

Supportive Evidence & Continuation Conditions

Supportive evidence and continuation request conditions — Continuation requests are allowed without meeting new-authorization inclusion criteria if all of the following are met: (1) the medication was used within the last year; (2) the member has not experienced disease progression and/or intolerance to the medication; and (3) no additional medications are being added to the continuation request. All requests must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

Continuation exemption applies only when the three conditions above are satisfied.
Documentation must reference accepted sources per CMS guidance.

Denial Risk

Denial Risk / Exclusion Criteria

Denial risks / Exclusion conditions — Requests will be denied when any exclusion applies, including disease progression while taking asciminib; use for Ph‑negative or BCR‑ABL negative CML; presence of excluded mutations (A337T, P465S); dosing above single-dose limits (80 mg for Ph+ CML or 200 mg for Ph+ CML with T315I); monthly quantity limits exceeded (60 x 20 mg, 60 x 40 mg, or 120 x 100 mg tablets); or investigational/off-label uses lacking sufficient evidence as defined by the policy.

Excluded mutations: A337T, P465S.
Single-dose limits: 80 mg (Ph+ CML) or 200 mg (Ph+ CML with T315I).
Monthly tablet limits: 60 (20 mg), 60 (40 mg), 120 (100 mg).
Off-label/investigational uses require robust supporting evidence per policy; inadequate evidence (case reports, poorly representative studies) may lead to denial.

Billing and coding

HCPCS codes listed for asciminibHCPCS

C9399	asciminib
J8999	asciminib

inv-05: Single dose limits

Single dose limit (Ph+ CML)80 mg per single dose

Single dose limit (Ph+ CML with T315I)200 mg per single dose

Policy referenceExceeding these single-dose limits is an exclusion and will trigger denial

inv-06: Monthly tablet maximums

Monthly maximum — 20 mg tablets60 tablets per month

Monthly maximum — 40 mg tablets60 tablets per month

Monthly maximum — 100 mg tablets120 tablets per month

Step therapy and prior treatment requirements

Prior therapy requirement	Applicable indication / notes
Prior treatment with >=2 tyrosine kinase inhibitors (TKIs), including imatinib and either nilotinib (Tasigna) or dasatinib (Sprycel)	Required for adult members with chronic phase CML who are not newly diagnosed (i.e., use after documented intolerance, contraindication, or disease progression on multiple TKIs)
No prior TKI requirement (newly diagnosed)	Asciminib may be used as monotherapy for adults with newly diagnosed chronic phase CML (no prior TKI failure required)
T315I mutation pathway	Asciminib is indicated for adults with CML and the T315I BCR-ABL mutation (use per mutation-specific indication)

Administration and monitoring guidance

Note

See FDA label for administration and monitoring

Refer to the FDA label/package insert for details about administration, dosing adjustments, and monitoring requirements for asciminib.

Use the FDA package insert for specific safety monitoring, dose modification, and administration instructions.

Definitions and key terms

inv-14: Ph+ / BCR-ABL+ CML

Covered diagnosisPhiladelphia chromosome-positive (Ph+) or BCR-ABL positive chronic myeloid leukemia (CML)

Covered disease phaseChronic phase (CP) CML, including newly diagnosed adult chronic phase

Supported usesUse as monotherapy per policy when inclusion criteria are met

inv-15: T315I mutation

Specific mutationT315I BCR-ABL mutation

IndicationAsciminib is indicated for adult members with CML and the T315I mutation

Policy placementT315I-mutant CML is listed as a covered indication in the CML section

Background

Asciminib (Scemblix) is a targeted BCR‑ABL STAMP inhibitor indicated for treatment of Philadelphia chromosome–positive (Ph+) or BCR‑ABL–positive chronic myeloid leukemia (CML). It may be used in newly diagnosed chronic phase CML, in patients with the T315I mutation, and in adults with CML after intolerance, contraindication, or progression on two or more tyrosine kinase inhibitors (including imatinib and either nilotinib or dasatinib), per FDA labeling and major oncology compendia/guidelines.