CurrentAnthemPolicy CC-0178

Synribo (omacetaxine mepesuccinate)

Criteria governing prior authorization and medical necessity for Synribo (omacetaxine mepesuccinate) in adults with chronic or accelerated phase chronic myeloid leukemia (CML), for Anthem members in North Carolina.

Policy Summary

PayerAnthem

PolicySynribo (omacetaxine mepesuccinate)

Policy CodePolicy CC-0178

Change TypeReviewed — no material changes

Effective Date07/01/2025

Next Review DateMay 16, 2025

Key ActionObtain prior authorization and document diagnosis plus resistance or intolerance to two or more TKIs.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2+ TKIsTKI requirement

Chronic/AcceleratedCML phases

2ANCCN level

12/26/2025Drug file removal

05/16/2025Last review

Coverage Criteria for Synribo (omacetaxine mepesuccinate)

Initial Therapy / Approval Criteria

Requests for Synribo (omacetaxine mepesuccinate) may be approved when ALL of the following are met:

Main approval criteria: Individual has a diagnosis of chronic or accelerated phase chronic myeloid leukemia (CML)

(Label, NCCN 2A)

Main approval criteria: Individual has resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs)

FDA‑approved TKIs include imatinib, dasatinib, nilotinib, bosutinib, ponatinib; NCCN 2A supports single-agent use for patients with resistance/intolerance to >=2 TKIs

Synribo (omacetaxine mepesuccinate) is scheduled for removal from the drug file on 12/26/2025; availability may be discontinued thereafter per Medispan. Providers should be aware that while the coverage criteria remain in effect until removal from the drug file, supply or formulary availability could change on or after that date.

Regimen	Indication / Notes	Coverage
Omacetaxine mepesuccinate (Synribo) — single agent	Single-agent use for chronic phase CML (CP-CML) in adults with resistance or intolerance to two or more tyrosine kinase inhibitors (TKIs); NCCN also notes possible use in accelerated phase disease and as post-allogeneic HCT follow-up for molecular relapse or relapse/less than CCyR.	Covered with criteria

Policy Summary

PayerAnthem

PolicySynribo (omacetaxine mepesuccinate)

Policy CodePolicy CC-0178

Change TypeReviewed — no material changes

Effective Date07/01/2025

Next Review DateMay 16, 2025

Key ActionObtain prior authorization and document diagnosis plus resistance or intolerance to two or more TKIs.

SourceLink

On This Page

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Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Synribo (omacetaxine) for chronic or accelerated phase CML. Approval criteria require a documented diagnosis of chronic or accelerated phase CML and evidence that the patient has had resistance or intolerance to prior therapies.

Prior authorization required before drug dispensation or infusion.
Approval requires documentation of diagnosis and prior treatment history.

Step Therapy

Step Therapy — TKI Failure/Intolerance Required

Step therapy requirement: patient must have tried and had resistance or intolerance to two or more FDA‑approved TKIs prior to approval of Synribo.

FDA‑approved TKIs include imatinib (Gleevec), dasatinib (Sprycel), nilotinib (Tasigna), bosutinib (Bosulif), and ponatinib (Iclusig).
Documented resistance or intolerance to at least two of the listed TKIs is required.

Documentation Required

Required Documentation

Submit complete documentation with the prior authorization request, including diagnosis and detailed prior treatment history showing resistance or intolerance to at least two TKIs. Relevant records include clinic notes, laboratory results (e.g., BCR‑ABL1 testing), treatment start/stop dates, and physician rationale for discontinuation of prior TKIs.

Include copies of prior oncology treatment records and any genetic or molecular testing (BCR‑ABL1 levels) supporting diagnosis and resistance/intolerance.
List dates and reasons for discontinuation of prior TKIs (e.g., progression, adverse events, intolerance).

Denial Risk

Denial Triggers

Requests may be denied if documentation does not support the diagnosis of chronic or accelerated phase CML or does not demonstrate resistance or intolerance to two or more FDA‑approved TKIs. Incomplete prior treatment records or lack of clear reason for TKI discontinuation are common denial triggers.

Denial triggers include missing or insufficient documentation of CML phase, and absence of evidence for resistance/intolerance to ≥2 TKIs.
Requests lacking treatment dates, reasons for TKI failure/intolerance, or relevant test results may be denied.

Single-agent indication	Clinical details / prerequisites	Coverage
Single-agent Synribo for chronic phase CML (CP-CML)	For adults with CP-CML who have resistance or intolerance to two or more FDA‑approved TKIs (examples: imatinib, dasatinib, nilotinib, bosutinib, ponatinib). NCCN (category 2A) also lists single-agent Synribo as an option in accelerated phase and as post-allogeneic HCT follow-up for molecular relapse or relapse/less than CCyR.	Covered with criteria

Definitions

First-line therapy (definition)

DefinitionThe first or primary treatment for the diagnosis, which may include surgery, chemotherapy, radiation therapy, or a combination of these therapies.

PurposeTypically used as initial management intended to induce remission or control disease before considering subsequent therapies.

Examples (contextual)May include surgery, systemic chemotherapy, targeted therapy, radiation, or multimodality approaches depending on the diagnosis.

Second-line and third-line therapy (definitions)

Second-line therapyTreatment given when initial treatment (first-line therapy) is not effective or there is disease progression.

Third-line therapyTreatment given when both initial (first-line) and subsequent (second-line) therapies are not effective or there is disease progression.

Use caseDescribes later-line options for patients with inadequate response or intolerance to prior therapies; informs step-therapy and prior authorization decisions.

Background

Synribo (omacetaxine mepesuccinate) is a protein synthesis inhibitor that reduces levels of Bcr-Abl and Mcl-1, proteins implicated in the initiation and progression of chronic myeloid leukemia (CML). The FDA-approved indication is for adults with chronic or accelerated phase CML who have demonstrated resistance or intolerance to two or more tyrosine kinase inhibitors (TKIs) (FDA‑approved TKIs include imatinib, dasatinib, nilotinib, bosutinib, and ponatinib).

The National Comprehensive Cancer Network (NCCN) lists single-agent Synribo as a Category 2A recommendation for patients with CP‑CML who have resistance or intolerance to two or more TKIs, and also notes potential uses in accelerated phase disease and as post‑allogeneic hematopoietic stem cell transplant follow-up for molecular relapse or incomplete cytogenetic response.

C92.10	Chronic myeloid leukemia, BCR/ABL-positive, not having achieved remission
C92.11	Chronic myeloid leukemia, BCR/ABL-positive, in remission
C92.12	Chronic myeloid leukemia, BCR/ABL-positive, in relapse

OpenPayer

Synribo (omacetaxine mepesuccinate)

Coverage Criteria for Synribo (omacetaxine mepesuccinate)

Applicable Coding

Provider Actions and Requirements

Line of Therapy Positioning

Covered Regimens and Agents

Definitions

Background