CurrentCignaPolicy IP0150

Oncology (Injectable) - Cosela

Defines Cigna's prior authorization, coverage criteria, dosing, and coding for Cosela (trilaciclib) when used to decrease chemotherapy‑induced myelosuppression in adults with extensive‑stage small cell lung cancer (SCLC). Affects prescribers, oncology providers, and billing staff under Cigna-administered plans.

Policy Summary

PayerCigna

PolicyOncology (Injectable) - Cosela

Policy CodePolicy IP0150

Change TypeDosing clarificationadded coadministration restriction

Effective DateJun 15, 2025

Next Review Date

Key ActionObtain prior authorization and document oncologist involvement; approve for 6 months when criteria met.

SourceLink

POLICY UPDATE CHANGES

Policy name updated from 'Trilaciclib Injection' to 'Oncology (Injectable) - Cosela' and dosing information for small cell lung cancer added.

Added criterion that Cosela will not be coadministered with a G-CSF or an erythropoiesis‑stimulating agent during the first cycle of chemotherapy.

Clarified dosing: approve one dose (240 mg/m2) administered as IV infusion for every day the chemotherapy regimen is given.

240 mg/m2recommended Cosela dose per administration

6 monthsinitial approval duration for FDA‑approved indication

J1448HCPCS billing code for trilaciclib

≥18

Policy Summary

PayerCigna

PolicyOncology (Injectable) - Cosela

Policy CodePolicy IP0150

Change TypeDosing clarificationadded coadministration restriction

Effective DateJun 15, 2025

Next Review Date

Key ActionObtain prior authorization and document oncologist involvement; approve for 6 months when criteria met.

SourceLink

On This Page

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Coverage Criteria for Cosela (trilaciclib)

FDA‑Approved Indication (Initial)

Approve for 6 months if the patient meets ALL of the following (A–F):

FDA‑Approved Indication - all required: A) Patient is ≥ 18 years of age; AND B) Patient has extensive‑stage disease; AND C) The medication is used to decrease the incidence of chemotherapy‑induced myelosuppression; AND D) Patient meets ONE of the following (i or ii): i. Patient will be receiving a platinum (carboplatin or cisplatin) and etoposide‑containing chemotherapy regimen; OR ii. Patient will be receiving a topotecan‑containing regimen; AND E) According to the prescriber, during the first cycle of chemotherapy, Cosela will not be coadministered with a granulocyte‑colony stimulating factor (G‑CSF) or an erythropoiesis‑stimulating agent (ESA); AND F) The medication is prescribed by or in consultation with an oncologist.

Approval duration: 6 months; dosing: 240 mg/m2 IV prior to each day chemotherapy is given.

Dosing

Dosing approval conditions

Dosing: Approve one dose (240 mg/m2) administered as an intravenous infusion for every day the chemotherapy regimen is given.240 mg/m2

Administer prior to start of chemotherapy each day it is given.

Cosela (trilaciclib) is not medically necessary for uses other than those specified in this policy. Coverage is limited to the indications and conditions described under the FDA‑Approved Indication and dosing criteria; requests for Cosela for any other diagnosis, setting, or purpose will be denied as not medically necessary.

Use of Cosela for indications other than to decrease the incidence of chemotherapy‑induced myelosuppression in adults with extensive‑stage small cell lung cancer (SCLC) is considered not medically necessary. Coverage is restricted to the specific clinical scenarios and dosing described in the FDA‑Approved Indication; therapies outside those parameters do not meet medical necessity criteria.

Billing and Coding

HCPCS CodesHCPCSCovered

C9078	Injection, trilaciclib, 1 mg (Code deleted 09/30/2021)
J1448	Injection, trilaciclib, 1 mg

inv-06: Dose per administration

Dose per administration240 mg/m2

Route / timingIntravenous infusion administered prior to the start of chemotherapy on each day chemotherapy is given.

Approval noteDosing specified in FDA‑Approved Indication and dosing sections of the policy.

What Providers Must Do / Watch For

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Cosela. Approvals are provided for the durations noted in the policy (e.g., 6 months for the FDA‑approved indication). Because of the specialized skills required for evaluation and diagnosis of patients treated with Cosela and monitoring for adverse events and long‑term efficacy, Cosela must be prescribed by or in consultation with a physician who specializes in the condition being treated (oncologist for the FDA‑approved indication). In cases where approval duration is given in months, 1 month = 30 days.

Prior authorization required: approvals provided for durations noted (e.g., 6 months for Small Cell Lung Cancer when all criteria met).
Prescriber requirement: must be prescribed by or in consultation with an oncologist for the FDA‑approved indication.
Approval duration interpretation: 1 month = 30 days.

Step Therapy

No Step Therapy Required

No step therapy requirements apply for Cosela under this policy (none specified).

Background

Cosela (trilaciclib) is a CDK4/6 inhibitor indicated to be given prior to certain chemotherapy regimens to decrease the incidence of chemotherapy‑induced myelosuppression in patients with extensive‑stage small cell lung cancer. It is administered as an intravenous infusion, with the approved dose being 240 mg/m2 given prior to each day chemotherapy is administered. In clinical evaluations, use during the first cycle prohibited prophylactic G‑CSF and ESA coadministration; therapeutic G‑CSF and transfusions were allowed as clinically indicated.

Key Definitions

inv-12: extensive‑stage disease as referenced in indication

TermExtensive‑stage disease (as referenced in indication)

ContextIndication applies to adults with extensive‑stage small cell lung cancer (SCLC) when Cosela is given prior to platinum/etoposide‑containing or topotecan‑containing regimens.

Clinical noteProphylactic G‑CSF and ESA were prohibited in Cycle 1 of pivotal studies; allowed from Cycle 2 if clinically indicated.

Initial Therapy (FDA‑approved)

Initial therapy (FDA‑approved). Approve when ALL of the following are met:

Initial approval: See FDA‑Approved Indication criteria: age ≥ 18, extensive‑stage disease, intended use to decrease chemotherapy‑induced myelosuppression, receiving either a platinum (carboplatin or cisplatin) plus etoposide regimen or a topotecan‑containing regimen, Cosela will not be coadministered with a G‑CSF or an ESA during the first cycle of chemotherapy, and the medication is prescribed by or in consultation with an oncologist.

Approve for 6 months; dose per administration = 240 mg/m2 IV prior to each day chemotherapy is given.

Continuation / Renewal Criteria

Continuation Therapy

Continuation/renewal — approvals are provided for the duration noted and must remain consistent with initial authorization:

Continuation: Approvals provided for the duration noted (example: initial FDA‑approved approval = 6 months). Continuation requires ongoing consistency with the approved indication, dosing (240 mg/m2 IV prior to each day chemotherapy is given), and that Cosela remains prescribed by or in consultation with an oncologist.

When authorized in months, 1 month = 30 days.

Step Therapy Guidance

Step	NCCN guidance	Policy requirement
1	NCCN lists Cosela or G‑CSF as prophylactic options to decrease the incidence of chemotherapy‑induced myelosuppression when given prior to platinum/etoposide ± immune checkpoint inhibitor‑containing regimens or a topotecan‑containing regimen for extensive‑stage SCLC (category 2A); also listed as prophylactic option for anemia/ RBC transfusion reduction (category 2B).	Policy does not mandate prior failure of G‑CSF; Cosela is an accepted prophylactic option per guideline and no step therapy requiring G‑CSF trial is specified.

Quantity Limits

inv-16: trilaciclib — Quantity limit

Quantity limitOne dose (240 mg/m2)

Frequency / perPer day of chemotherapy administration (administer prior to chemotherapy each day it is given)

Unitmg/m2 per administration

Site of Care

Note

Infuse IV prior to each chemotherapy day at appropriate infusion site

Administer one dose (240 mg/m2) as an intravenous infusion prior to the start of chemotherapy on each day chemotherapy is given; the infusion site should be appropriate for IV chemotherapy administration.

Dose per administration: 240 mg/m2 IV given prior to each chemotherapy day.
Site of care: infusion center or other setting appropriate for IV chemotherapy administration.