CurrentBlue Cross Blue Shield - IowaPolicy 05.04.53

Scemblix (asciminib) coverage

Defines prior authorization, documentation, dosing/quantity limits, and medical necessity criteria for Scemblix (asciminib) for treatment of Philadelphia chromosome–positive CML and certain ABL1-rearranged neoplasms for Wellmark/Blue Cross Blue Shield members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyScemblix (asciminib) coverage

Policy CodePolicy 05.04.53

Change TypeNo material change

Effective DateApr 15, 2025

Next Review Date

Key ActionObtain prior authorization with required mutation and cytogenetic/molecular testing and submit documentation of clinical benefit for reauthorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization period

60/30d20 mg limit

240/30d40 mg limit

120/30d100 mg limit

YesT315I listed

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Initial Therapy

Authorization of 12 months may be granted when ALL of the following (by criteria group) are met:

CML - initial approval: Member has Philadelphia chromosome–positive chronic myeloid leukemia (CML) in chronic phase (CP) as one of the following: newly diagnosed and requested medication will be used as a single agent; previously treated CP with BCR‑ABL1 mutation testing negative for A337T, P465S, M244V and F359V/I/C; T315I mutation–positive CP with BCR‑ABL1 mutation testing results and negative for A337T, P465S, M244V and F359V/I/C; OR CML in accelerated phase (AP) that has not tested positive for A337T, P465S, M244V and F359V/I/C and the requested medication will be used as a single agent.

See Documentation for required mutation and cytogenetic/molecular testing results.

Myeloid/Lymphoid Neoplasms with Eosinophilia: Member has a myeloid and/or lymphoid neoplasm with eosinophilia and confirmed ABL1 rearrangement (chronic phase or blast phase).

See Documentation for required testing to confirm ABL1 rearrangement.

Continuation Therapy

Authorization of 12 months may be granted for continued treatment when ALL of the following are met:

Continuation: No evidence of unacceptable toxicity or disease progression while on the current regimen; AND submission of medical records documenting clinical benefit (e.g., chart notes, laboratory values, pulmonary function tests, CFQ‑R score).

Authorization granted for 12 months if met; see Documentation for required supporting records.

Scemblix (asciminib) is not medically necessary when the member does not meet the specific coverage criteria detailed in this policy. Requests that lack required documentation of diagnosis, mutation or cytogenetic/molecular testing, evidence of clinical benefit for continuation, or any of the stated eligibility conditions will be denied as not medically necessary.

Scemblix (asciminib) is considered not medically necessary for members who do not meet the criteria set forth in this policy. Prior authorization will be denied or not approved when applicable diagnostic, mutation-testing, or continuation-of-therapy documentation is missing or when the member’s clinical situation does not satisfy the policy’s listed indications and requirements.

Initial Therapy — Medical Necessity Conditions

Initial Therapy

Initial approval criteria (12 months) for specified diagnoses and required mutation/test results:

Allowed initial scenarios for CML: Newly diagnosed CML in chronic phase (CP) with single‑agent use; OR previously treated CML‑CP with BCR‑ABL1 mutation testing negative for A337T, P465S, M244V and F359V/I/C; OR T315I mutation–positive CML‑CP with BCR‑ABL1 mutation testing results provided and negative for A337T, P465S, M244V and F359V/I/C; OR CML in accelerated phase (AP) that has not tested positive for A337T, P465S, M244V and F359V/I/C with single‑agent use.

Mutation testing as specified is required prior to initiation.

Myeloid/Lymphoid Neoplasms: Confirmed ABL1 rearrangement for myeloid and/or lymphoid neoplasms with eosinophilia (chronic or blast phase).

Testing/analysis confirming ABL1 rearrangement must be provided.

Continuation of Therapy Criteria

Continuation of Therapy

Criteria for reauthorization (authorization of 12 months may be granted when all are met):

Reauthorization requirements: No unacceptable toxicity or disease progression on current regimen; AND medical records document clinical benefit (examples: chart notes, laboratory values, pulmonary function tests, CFQ‑R score).

Authorization granted for 12 months if requirements met; submit required documentation per Documentation section.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization of up to 12 months may be granted when the specified diagnosis and mutation/testing criteria are met.

Authorization duration: up to 12 months
Applicable diagnoses: Philadelphia chromosome–positive (Ph+) CML; myeloid/lymphoid neoplasms with eosinophilia and ABL1 rearrangement

Step Therapy

No explicit step therapy sequencing requirements are stated in this policy.

Documentation Required

Required Documentation for Prior Authorization Review

Prior authorization review requires documentation to support the diagnosis and mutation/testing status before initiation and for continuation of therapy. For initiation: provide cytogenetic and/or molecular testing results confirming the Ph chromosome or BCR-ABL gene for CML; for T315I-positive CML, provide BCR-ABL1 mutation testing results specifying T315I and demonstrating testing for A337T, P465S, M244V and F359V/I/C mutations; for myeloid/lymphoid neoplasms with eosinophilia, provide testing confirming ABL1 rearrangement. For continuation requests: submit medical records (e.g., chart notes, laboratory values, pulmonary function tests, CFQ-R score) documenting clinical benefit from therapy and no evidence of disease progression.

Initiation — cytogenetic and/or molecular testing confirming Ph chromosome or BCR-ABL gene
Initiation (T315I CML) — BCR-ABL1 mutation testing for T315I and documentation testing for A337T, P465S, M244V, F359V/I/C
Initiation (neoplasms with eosinophilia) — testing confirming ABL1 rearrangement
Continuation — medical records documenting clinical benefit and no disease progression (chart notes, labs, PFTs, CFQ‑R score)

Denial Risk

Not Meeting Criteria

Scemblix (asciminib) is considered not medically necessary for members who do not meet the criteria set forth in this policy.

Quantity Limits by Strength

Scemblix (asciminib) 20 mg tablet

Pack size / limit60 tablets per 30 days

DrugScemblix (asciminib) 20 mg tablet

ContextFDA-recommended dosing and quantity limit listed in policy

Scemblix (asciminib) 40 mg tablet

Pack size / limit240 tablets per 30 days

DrugScemblix (asciminib) 40 mg tablet

ContextFDA-recommended dosing and quantity limit listed in policy

Scemblix (asciminib) 100 mg tablet

Pack size / limit120 tablets per 30 days

DrugScemblix (asciminib) 100 mg tablet

ContextFDA-recommended dosing and quantity limit listed in policy

Step Therapy Considerations

Step	Requirement
1	Policy does not specify required trials of other agents prior to asciminib; approval is based on meeting the specified diagnosis and mutation testing criteria (e.g., CML in chronic phase — newly diagnosed single‑agent use; previously treated CP with negative mutation testing for A337T, P465S, M244V, F359V/I/C; T315I‑positive CP with required BCR‑ABL1 mutation testing negative for A337T, P465S, M244V, F359V/I/C; or CML in accelerated phase not positive for listed mutations and single‑agent use).

Step

Requirement

Policy does not specify required trials of other agents prior to asciminib; approval is based on meeting the specified diagnosis and mutation testing criteria (e.g., CML in chronic phase — newly diagnosed single‑agent use; previously treated CP with negative mutation testing for A337T, P465S, M244V, F359V/I/C; T315I‑positive CP with required BCR‑ABL1 mutation testing negative for A337T, P465S, M244V, F359V/I/C; or CML in accelerated phase not positive for listed mutations and single‑agent use).

Background

Asciminib (Scemblix) is a BCR-ABL inhibitor indicated for Philadelphia chromosome–positive chronic myeloid leukemia (CML) in chronic phase, including newly diagnosed disease, previously treated disease, and disease with the T315I mutation, and it also has compendial use for certain ABL1-rearranged myeloid/lymphoid neoplasms and for some accelerated-phase CML scenarios. The policy aligns coverage with FDA labeling and accepted compendia, specifying diagnosis and mutation-testing requirements as the basis for prior authorization and coverage decisions.

Prior authorization is required for Scemblix; when criteria are met (including confirmation of Ph chromosome or BCR‑ABL and any indicated mutation testing), authorization of 12 months may be granted for both initial and continuation therapy. The policy also defines required documentation for review and states that therapy is not medically necessary if the policy criteria are not satisfied.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyScemblix (asciminib) coverage

Policy CodePolicy 05.04.53

Change TypeNo material change

Effective DateApr 15, 2025

Next Review Date

Key ActionObtain prior authorization with required mutation and cytogenetic/molecular testing and submit documentation of clinical benefit for reauthorization.

SourceLink

On This Page

OpenPayer

Scemblix (asciminib) coverage

Coverage Criteria for Scemblix (asciminib)

Initial Therapy — Medical Necessity Conditions

Continuation of Therapy Criteria

Provider Actions and Requirements

Procedures and Billing / Code Tables

Quantity Limits by Strength

Step Therapy Considerations

Definitions and Key Terms

Background