CurrentEmblemHealthPolicy MG.MM.PH.337

Cosela (trilaciclib) for chemotherapy-induced myelosuppression in extensive-stage small cell lung cancer

Defines medical necessity and prior authorization criteria for trilaciclib (Cosela) administered prior to platinum/etoposide- or topotecan-based chemotherapy in adults with extensive-stage small cell lung cancer for reduction of chemotherapy-induced myelosuppression; applies to EmblemHealth/ConnectiCare members and treating providers.

Policy Summary

PayerEmblemHealth

PolicyCosela (trilaciclib) for chemotherapy-induced myelosuppression in extensive-stage small cell lung cancer

Policy CodePolicy MG.MM.PH.337

Change TypeMaterial changes to dosing, renewal, and CSF concomitant-use restriction

Effective Date

Next Review Date

Key ActionSubmit clinical evidence that the member meets the policy criteria for prior authorization (J1448) including confirmation of qualifying regimen and that trilaciclib will not be used with CSFs for primary prophylaxis.

SourceLink

POLICY UPDATE CHANGES

Will not be used concomitantly with colony stimulating factors (e.g., G-CSF, peg-G-CSF, GM-CSF) for primary prophylaxis of febrile neutropenia prior to day 1 of chemotherapy.

Updated dosing limits and added renewal criteria.

Updated ICD-10 diagnosis codes and removed certain lung cancer diagnosis codes in 2023 revision.

600 mgmaximum billable units (per dose)

6 monthsinitial authorization length

≥18patient age requirement

Prior to platinum/topotecanadministration timing/indication

Coverage Criteria for Cosela (trilaciclib)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial approval for ES-SCLC to decrease chemotherapy-induced myelosuppression

Patient characteristics
- Age: Patient is 18 years of age or older>=18
- Diagnosis stage: Patient has extensive-stage small cell lung cancer (ES-SCLC)ES-SCLC

Policy Summary

PayerEmblemHealth

PolicyCosela (trilaciclib) for chemotherapy-induced myelosuppression in extensive-stage small cell lung cancer

Policy CodePolicy MG.MM.PH.337

Change TypeMaterial changes to dosing, renewal, and CSF concomitant-use restriction

Effective Date

Next Review Date

SourceLink

On This Page

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Renewal Therapy — Renewal covered when ALL of the following are met

Renewal covered when ALL of the following are met

Renewal criteria

Continued eligibility: Patient continues to meet Initial Criteria
Toxicity: Absence of unacceptable toxicity from trilaciclib (examples: severe injection site reactions including phlebitis/thrombophlebitis, acute hypersensitivity reactions, interstitial disease/pneumonitis)
Ongoing chemotherapy regimen
- Platinum/etoposide: Patient continues on a platinum (carboplatin or cisplatin) and etoposide-containing regimen
- Topotecan: Patient continues on a topotecan-containing regimen

Authorization period context: Renewal authorizations should align with ongoing receipt of qualifying myelosuppressive chemotherapy

Regimens and Administration Schedules

Regimen	Cosela dosing schedule	Administration timing/notes
Platinum (carboplatin or cisplatin) + etoposide	Cosela on days 1, 2, and 3 every 21 days	Administer trilaciclib prior to chemotherapy; will not be used concomitantly with colony stimulating factors for primary prophylaxis prior to day 1 of chemotherapy
Topotecan-containing regimen	Cosela on days 1 through 5 every 21 days	Administer trilaciclib prior to chemotherapy; patient must be adult with extensive-stage disease and Cosela prescribed by or in consultation with an oncologist

first-line — Line of therapy specification

Qualifying chemotherapy regimens for use prior to trilaciclib

Platinum/etoposide regimen: Administration prior to a platinum (carboplatin or cisplatin) plus etoposide-containing regimen
Topotecan regimen: Administration prior to a topotecan-containing regimen

Billing and Coding

Covered HCPCS CodesHCPCSCovered

J1448

Injection, trilaciclib, 1 mg

Applicable NDCsNDC

Cosela (trilaciclib) 300 mg single dose vial

Applicable ICD-10/Diagnosis CodesICD-10

D61.81	Pancytopenia
D70.1	Agranulocytosis secondary to cancer chemotherapy
D70.9	Neutropenia, unspecified
T45.1XSA	Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter
T45.1XSD	Adverse effect of antineoplastic and immunosuppressive drugs, subsequent encounter
T45.1XSS	Adverse effect of antineoplastic and immunosuppressive drugs, sequela
Z51.11	Encounter for antineoplastic chemotherapy
Z51.12	Encounter for antineoplastic immunotherapy
D61.81	Pancytopenia

Dose and Unit Limits

Dose per administration240 mg/m2; 600 mg per dose (maximum billable units)

Maximum billable units600 billable units (600 mg) per dose

Administration scheduleOn days 1,2,3 every 21 days when used with etoposide; On days 1-5 every 21 days when used with topotecan

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization is required; documentation must show patient meets initial approval criteria.

Policy Number: MG.MM.PH.337
Indication: Cosela (trilaciclib) for prevention of chemotherapy-induced myelosuppression in small cell lung cancer
Member age: ≥ 18 years
Prescriber: Oncologist or in consultation with an oncologist

Documentation Required

Concomitant CSF Restriction

Concomitant CSF restriction — Trilaciclib must not be used concomitantly with colony stimulating factors for primary prophylaxis.

Do not use with G-CSF, pegylated G-CSF, GM-CSF, or other colony stimulating factors for primary prophylaxis prior to Day 1 of the chemotherapy cycle.
If CSF is clinically indicated after chemotherapy-related neutropenia occurs (therapeutic use), document rationale and timing.

Documentation Required

Clinical Documentation Required

Clinical documentation required — Treating provider must submit clinical evidence for preauthorization.

Documentation must demonstrate diagnosis of extensive-stage small cell lung cancer.
Regimen details: planned chemotherapy regimen (platinum + etoposide OR topotecan-containing regimen).
Planned dosing schedule for trilaciclib and chemotherapy, and oncologist consultation note if applicable.

Denial Risk

Missing Clinical Documentation

Missing clinical documentation — Requests lacking required documentation may be denied.

Incomplete or absent evidence of diagnosis, chemotherapy regimen, prescriber specialty, or documentation of non-use of CSF for primary prophylaxis may result in denial.
Ensure all requested medical records, treatment plans, and rationale are submitted at time of preauthorization.

Background and Drug Information

Trilaciclib (Cosela) is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor indicated to decrease the incidence of chemotherapy‑induced myelosuppression when administered prior to qualifying chemotherapy regimens in adults with extensive‑stage small cell lung cancer (ES‑SCLC). The policy frames trilaciclib as a preventative agent given immediately before either a platinum (carboplatin or cisplatin) plus etoposide regimen (Cosela on days 1–3 of a 21‑day cycle) or a topotecan‑containing regimen (Cosela on days 1–5 of a 21‑day cycle) to reduce myelosuppressive complications.

Dosing guidance in the document specifies a per‑dose limit of 240 mg/m2 (up to 600 mg per dose; 600 billable units); administration must occur prior to the qualifying chemotherapy. Use is restricted by the policy from concomitant use with colony stimulating factors for primary prophylaxis of febrile neutropenia prior to day 1 of chemotherapy.

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