CurrentUnitedHealthcarePolicy 2025 P 1374-5

Scemblix (asciminib) prior authorization

Defines UnitedHealthcare prior authorization and reauthorization criteria for Scemblix (asciminib) for oncology indications, and applies to prescribers submitting coverage requests (members <19 auto-process).

Policy Summary

PayerUnitedHealthcare

PolicyScemblix (asciminib) prior authorization

Policy CodePolicy 2025 P 1374-5

Change TypeAdded and revised indications (material)

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization for Scemblix; prescriptions for members under 19 years auto-process and are approved for 12 months.

SourceLink

POLICY UPDATE CHANGES

Added new coverage criteria for ALL per NCCN.

Updated CML criteria per NCCN guidelines and new expanded indication.

Added criteria for Myeloid/Lymphoid Neoplasms with Eosinophilia and ABL1 gene rearrangement.

Updated background and references to include new label and NCCN compendium.

12 monthsauthorization duration

age <19auto-process age

4distinct indication groups

2021-2025P&T history

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria and Eligibility

Initial Therapy - CML

Covered when ALL of the following are met

CML Initial Authorization: (1) Diagnosis of chronic myeloid leukemia (CML) AND (2) Disease is Philadelphia chromosome (Ph+) or BCR:ABL1-positive AND (3) One of: (a) newly diagnosed chronic phase CML (CP-CML) OR (b) previously treated CP-CML OR (c) CP-CML positive for a T315I mutation OR (d) accelerated phase CML (AP-CML) as primary single-agent treatment

Reauthorization - CML

Covered when ALL of the following are met

CML Reauthorization: Patient does not show evidence of progressive disease while on Scemblix therapy

Authorization issued for 12 months upon reapproval

Initial Therapy - Myeloid/Lymphoid neoplasm with ABL1 rearrangement

Covered when BOTH of the following are met

Myeloid/Lymphoid Initial: (1) Diagnosis of myeloid/lymphoid neoplasm with eosinophilia and ABL1 rearrangement AND (2) Disease is in chronic or blast phase

Reauthorization - Myeloid/Lymphoid neoplasm

Covered when ALL of the following are met

Myeloid/Lymphoid Reauthorization: Patient does not show evidence of progressive disease while on Scemblix therapy

Authorization issued for 12 months upon reapproval

Initial Therapy - Ph+ B-ALL (relapsed/refractory)

Covered when ALL of the following are met

B-ALL Initial: (1) Diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) AND (2) Disease is Philadelphia chromosome (Ph+) or BCR:ABL1-positive AND (3) Disease is relapsed/refractory AND (4) Used in combination with dasatinib

Reauthorization - B-ALL

Covered when ALL of the following are met

B-ALL Reauthorization: Patient does not show evidence of progressive disease while on Scemblix therapy

Authorization issued for 12 months upon reapproval

Automatic Processing - Patients <19 years

Covered when the following is met

Pediatric Automatic Approval: Patient is less than 19 years of age

Authorization will be issued for 12 months

Some state mandates may supersede this document for off‑label uses. Where such mandates apply, they supersede language in this policy or the notification criteria. Otherwise, coverage for Scemblix (asciminib) is limited to the indications and criteria listed in this policy and members must meet the specified requirements for authorization. For members under 19 years the prescription will automatically process without a coverage review.

Use of Scemblix outside the specific diagnoses and disease phases described in this policy would not meet the listed coverage criteria. Specifically, therapy that is not for the approved disease designations (e.g., CML, myeloid/lymphoid neoplasm with ABL1 rearrangement, or Ph+ B‑ALL as described), for the required disease phase, or that does not follow required combination therapy (for Ph+ B‑ALL relapsed/refractory the agent must be used in combination with dasatinib) is not consistent with the coverage criteria and therefore would be considered not medically necessary under this policy.

Initial Authorization Criteria by Indication

Initial Therapy — Initial authorization criteria by indication

Initial authorization criteria by indication

Initial - CML: See CML Initial Authorization criteria: diagnosis of CML, Ph+ or BCR:ABL1-positive, and one of specified CML subgroups (newly diagnosed CP-CML, previously treated CP-CML, CP-CML with T315I mutation, or AP-CML as single-agent primary treatment)

Initial - Myeloid/Lymphoid: Diagnosis of myeloid/lymphoid neoplasm with eosinophilia and ABL1 rearrangement in chronic or blast phase

Initial - B-ALL: Ph+ B-ALL that is relapsed/refractory and used in combination with dasatinib

Initial - Pediatric: Patient under 19 years is automatically approved

Reauthorization / Continuation Requirements

Reauthorization / Continuation — Reauthorization criteria

Reauthorization criteria

Continuation/Reauthorization: Patient does not show evidence of progressive disease while on Scemblix therapy

Authorization issued for 12 months upon reapproval

Provider Requirements and Operational Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required for Scemblix except for prescriptions for members under 19 years of age which automatically process without a coverage review; authorizations for patients under 19 will be issued for 12 months. Initial and reauthorization requests for members aged 19 and older must meet the clinical diagnosis and disease-phase criteria specified in the Coverage Information (e.g., CML Ph+ / BCR:ABL1-positive with specified phase or mutation, myeloid/lymphoid neoplasm with ABL1 rearrangement in chronic or blast phase, or relapsed/refractory Ph+ B-ALL when used with dasatinib).

Prior authorization required for Scemblix for members ≥ 19 years
Members < 19 years — prescriptions automatically process; authorization issued for 12 months
Authorization decisions for adults depend on meeting the specific diagnosis/phase criteria in the policy

Denial Risk

Denial Triggers

Coverage may be denied if the member does not meet the specified diagnosis or disease-phase criteria (for example: diagnosis not listed, disease not Ph+ / BCR:ABL1-positive when required, incorrect disease phase, or absence of required mutation/combination therapy). Providers should ensure submitted diagnosis codes and clinical documentation correspond to the policy criteria. Supply limits or step edits in the benefit may also lead to denials if exceeded.

Key Definitions and Disease Phases

inv-15: CP-CML — Chronic phase CML (CP-CML)

DefinitionChronic phase chronic myeloid leukemia (CP-CML)

Covered indicationsNewly diagnosed CP-CML, previously treated CP-CML, CP-CML positive for a T315I mutation, or accelerated phase CML (AP-CML) as primary single‑agent treatment

Molecular requirementDisease must be Philadelphia chromosome (Ph+) or BCR:ABL1‑positive

Approval basisInitial authorization requires all listed criteria to be met: diagnosis of CML, Ph+/BCR:ABL1+, and one of the specified CML subgroups

inv-16: Myeloid/lymphoid neoplasm with ABL1 rearrangement — Myeloid/lymphoid neoplasm with eosinophilia and ABL1 rearrangement in chronic or blast phase

Definition

Background and Clinical Context

Scemblix (asciminib) is a kinase inhibitor with coverage criteria established for oncology indications including chronic myeloid leukemia and other ABL1‑driven diseases. UnitedHealthcare authorizes Scemblix for adult patients with Philadelphia chromosome (Ph+) or BCR:ABL1‑positive chronic myeloid leukemia (CML) in specified settings: newly diagnosed chronic phase CML (CP‑CML), previously treated CP‑CML, CP‑CML with a T315I mutation, and accelerated phase CML (AP‑CML) as primary single‑agent treatment. The policy also covers Scemblix for myeloid/lymphoid neoplasm with eosinophilia and ABL1 rearrangement in chronic or blast phase, and for relapsed/refractory Ph+ B‑ALL when used in combination with dasatinib. Authorization durations and reauthorization requirements are specified elsewhere in the policy.

Step Therapy and Quantity Limits

Note	Details
Supply limits and/or step therapy may be in place
UnitedHealthcare may implement supply limits and/or step therapy edits for Scemblix; the document does not specify the exact step requirements or supply thresholds.

Policy Changes and History

2026-03-01effective_dateLatest

Policy became effective with updated coverage criteria and approvals effective March 1, 2026.

2025-12-01annual_review

Annual review added new coverage criteria for ALL per NCCN and updated background and references.

2024-12-01annual_review

Annual review updated CML criteria per NCCN guidelines and expanded indication; background and references updated.