CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cosela (trilaciclib) — Coverage Criteria (myelopreservation)

Defines accepted indications and evidence requirements for Cosela (trilaciclib) use in cancer treatment and governs medication authorization decisions processed by Evolent for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCosela (trilaciclib) — Coverage Criteria (myelopreservation)

Policy CodePolicy N/A

Change TypeTemplate and reference updates

Effective DateN/A

Next Review DateMar 1, 2025

Key ActionSubmit prior authorization with supporting FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced UM ONC 1424 Cosela (trilaciclib).

Updated NCH verbiage to Evolent.

J1448HCPCS code listed for trilaciclib

ES-SCLCSpecific cancer indication discussed

Mar 2025Policy history update date

FDA PI (2023)Reference included

Coverage Criteria for Cosela (trilaciclib)

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Not supported for ES-SCLC

Policy position for extensive-stage small cell lung cancer (ES-SCLC):

ES-SCLC noncoverage rationale: Cosela (trilaciclib) is not supported by Evolent Policy for use to prevent chemotherapy‑induced myelosuppression in extensive‑stage small cell lung cancer.

Based on trials showing no improvement in progression‑free or overall survival, no trials used febrile neutropenia as a primary efficacy endpoint, widespread G‑CSF use in trials with no demonstrated additional reduction in febrile neutropenia when trilaciclib was added, nonsignificant differences in ESA use and platelet transfusions, and no Level‑1 evidence that Cosela plus G‑CSF reduces febrile neutropenia versus G‑CSF alone.

Cosela (trilaciclib) is considered investigational or off-label when used for indications that lack sufficient, generally accepted evidence. Requests for such uses must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature that meet CMS Medicare Benefit Policy Manual Chapter 15 standards. Case reports, meeting abstracts without full peer‑reviewed publication, or evidence that does not adequately represent the patient population, regimen, or clinically meaningful outcomes are generally insufficient to establish medical necessity.

Use of Cosela (trilaciclib) to prevent chemotherapy‑induced myelosuppression in extensive‑stage small cell lung cancer (ES‑SCLC) is not supported by this policy. The clinical trials reviewed did not use febrile neutropenia as a primary efficacy endpoint, allowed substantial G‑CSF use in both arms, and showed no Level‑1 evidence that Cosela plus G‑CSF reduces febrile neutropenia versus G‑CSF alone. Trials also demonstrated no significant differences in ESA use or platelet transfusions and no improvements in progression‑free or overall survival; therefore Cosela for this indication may be denied.

Regimen	Clinical context / trial notes	Coverage status
Cosela (trilaciclib) used with standard first-line chemotherapy regimens for extensive‑stage small cell lung cancer (ES‑SCLC)
Trials reviewed allowed G‑CSF use; no improvement in PFS or OS observed; no Level 1 evidence that Cosela plus G‑CSF reduces febrile neutropenia versus G‑CSF alone
Policy does not support use to prevent chemotherapy‑induced myelosuppression in ES‑SCLC

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for trilaciclib (Cosela). Submit requests that reference the applicable billing code and include clinical justification based on accepted evidence sources.

J1448 Injection, trilaciclib, 1 mg

Note

Supportive Care Consideration Prior to Cosela

Before requesting Cosela, clinicians should demonstrate that standard supportive care measures were considered or used. Trials allowed granulocyte colony-stimulating factor (G-CSF) and other supportive care (ESAs, platelet transfusions); Evolent notes no clear additive clinical benefit of Cosela over these measures.

Documentation Required

Documentation and Evidence Sources Required for Requests

Requests must be supported by one of the following: FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards. Include cited references and documentation demonstrating that the patient population, chemotherapy regimen, and reported outcomes in the evidence apply to the requested use.

FDA label
CMS-approved compendia
NCCN/ASCO guidelines
Peer-reviewed literature meeting CMS Chapter 15 requirements

Denial Risk

Not Supported for ES-SCLC — Actionable Denial Guidance

Use of Cosela to prevent chemotherapy-induced myelosuppression in extensive-stage small cell lung cancer (ES-SCLC) is not supported by Evolent. If requesting coverage for this indication, expect denial — provide high-quality, compendia-supported evidence that meets the exclusion criteria standards to overturn this position.

Background on Trilaciclib (Cosela)

Trilaciclib (Cosela) is a CDK4/6 inhibitor that has been investigated as a myelopreservation strategy to prevent chemotherapy‑induced myelosuppression. Randomized phase II and other studies assessed its effects on blood count preservation while allowing use of supportive care measures (for example, G‑CSF, ESAs, and platelet transfusions). The evidence reviewed did not demonstrate clinically meaningful improvements in key patient outcomes (including febrile neutropenia, PFS, or OS) beyond standard supportive care.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCosela (trilaciclib) — Coverage Criteria (myelopreservation)

Policy CodePolicy N/A

Change TypeTemplate and reference updates

Effective DateN/A

Next Review DateMar 1, 2025

Key ActionSubmit prior authorization with supporting FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

On This Page

OpenPayer

Cosela (trilaciclib) — Coverage Criteria (myelopreservation)

Coverage Criteria for Cosela (trilaciclib)

Billing and Coding

Provider Actions and Authorization Requirements

Background on Trilaciclib (Cosela)

Definitions and Contraindications

Line of Therapy Considerations

Policy Revision History