CurrentViva HealthPolicy IC-0592

Cosela (trilaciclib) — prophylactic myelopreservation for chemotherapy-induced myelosuppression in ES-SCLC

Policy governing prior authorization, dosing, and coverage criteria for intravenous trilaciclib (Cosela) to reduce chemotherapy-induced myelosuppression in adults with extensive-stage small cell lung cancer (ES-SCLC) receiving specified myelosuppressive chemotherapy regimens. Affects providers seeking coverage from Viva Health.

Policy Summary

PayerViva Health

PolicyCosela (trilaciclib) — chemotherapy-induced myelosuppression in ES-SCLC

Policy CodePolicy IC-0592

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization; initial authorization valid for 4 months and may be renewed every 4 months if renewal criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J1448HCPCS code

3000Max units/21d

>=18Min age

240 mg/m2Dose

Coverage Criteria for Trilaciclib (Cosela)

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Initial Approval Criteria: Patient is at least 18 years of age; AND Will not be used concomitantly with colony stimulating factors for primary prophylaxis of febrile neutropenia prior to day 1 cycle 1 of chemotherapy; AND Patient has a diagnosis of extensive-stage small cell lung cancer (ES-SCLC); AND Used as prophylactic therapy to decrease the incidence of chemotherapy-induced myelosuppression; AND Patient is undergoing myelosuppressive chemotherapy with one of the following: platinum (carboplatin or cisplatin) plus etoposide-containing regimen OR a topotecan-containing regimen.

Includes FDA-approved and compendia-recommended indications.

inv-02: Renewal Criteria

Renewal criteria — Covered when ALL of the following are met:

Renewal Criteria: Patient continues to meet universal and other indication-specific relevant criteria (including concomitant therapy requirements and performance status); AND Absence of unacceptable toxicity from the drug (examples: severe injection site reactions including phlebitis/thrombophlebitis, acute hypersensitivity including facial edema and urticaria, interstitial lung disease/pneumonitis); AND Patient continues to undergo myelosuppressive chemotherapy with one of the following: platinum (carboplatin or cisplatin) plus etoposide-containing regimen OR a topotecan-containing regimen.

Authorizations may be renewed every 4 months if renewal criteria are met.

Trilaciclib must not be administered concurrently with colony stimulating factors when those agents are being used for primary prophylaxis of febrile neutropenia prior to day 1, cycle 1 of chemotherapy. This restriction is part of the policys universal criteria and is intended to avoid overlapping preventive strategies initiated before the first dose of cytotoxic chemotherapy.

Requests for trilaciclib outside the specified indication are not consistent with coverage. Coverage is limited to use as prophylactic myelopreservation in patients with extensive-stage small cell lung cancer (ES-SCLC) who are undergoing one of the covered myelosuppressive chemotherapy regimens: either a platinum (carboplatin or cisplatin) plus etoposidecontaining regimen or a topotecan-containing regimen. Use for diagnoses other than ES-SCLC or with chemotherapy regimens other than the regimens listed above is considered not medically necessary under this policy.

Regimen	Cosela (trilaciclib) dosing schedule	Coverage status
Platinum (carboplatin or cisplatin) + etoposide-containing regimen	Cosela administered on days 1–3 of a 21-day cycle; recommended dose 240 mg/m2 per dose given as a 30-minute IV infusion completed within 4 hours prior to chemotherapy on each chemotherapy day (interval between sequential doses ≤28 hours)	Covered
Topotecan-containing regimen	Cosela administered on days 1–5 of a 21-day cycle; recommended dose 240 mg/m2 per dose given as a 30-minute IV infusion completed within 4 hours prior to chemotherapy on each chemotherapy day (interval between sequential doses ≤28 hours)	Covered

Coding and Billing

Covered HCPCS CodesHCPCSCovered

J1448

Injection, trilaciclib, 1 mg; 1 billable unit = 1 mg

NDCNDC

73462-0101-xx

Cosela 300 mg single-dose vial (NDC)

Covered Diagnosis CodesICD-10Covered

D61.810	Antineoplastic chemotherapy induced pancytopenia
D70.1	Agranulocytosis secondary to cancer chemotherapy
D70.9	Neutropenia, unspecified
T45.1X5A	Adverse effect of antineoplastic and immunosuppressive drugs initial encounter
T45.1X5D	Adverse effect of antineoplastic and immunosuppressive drugs subsequent encounter
T45.1X5S	Adverse effect of antineoplastic and immunosuppressive drugs sequela
Z51.11	Encounter for antineoplastic chemotherapy
Z51.12	Encounter for antineoplastic immunotherapy

inv-08: Max per 21 days — 3000 mg (3000 billable units)

Maximum dose per 21 days3000 mg (3000 billable units)

HCPCS unit definition1 billable unit = 1 mg (HCPCS billing applies)

Billing intervalLimit applies every 21 days

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorization will be provided for 4 months and may be renewed every 4 months if renewal criteria are met.

Initial authorization: 4 months
Renewal authorization: every 4 months (if renewal criteria met)

Denial Risk

Concomitant Therapy Restriction

Must not be used concomitantly with colony stimulating factors for primary prophylaxis of febrile neutropenia prior to day 1 of cycle 1 of chemotherapy.

Do not administer with CSFs for primary prophylaxis before day 1, cycle 1

Prior Authorization

Indication and Age Restrictions

Coverage is limited to adults (≥18 years) with extensive-stage small cell lung cancer (ES-SCLC) undergoing specified myelosuppressive chemotherapy. Requests for patients outside these indications or age must include clinical justification.

Age restriction: ≥18 years
Indication restriction: ES-SCLC
Permitted chemotherapy regimens: platinum (carboplatin or cisplatin) + etoposide, or topotecan-containing regimen

Documentation Required

Required Diagnosis Coding

Submit diagnosis codes consistent with covered diagnoses when requesting authorization.

D61.810
D70.1
D70.9
T45.1X5A
T45.1X5D
T45.1X5S
Z51.11
Z51.12

Line of Therapy

inv-15: first-line

Line of therapy: Policy references use with first-line chemotherapy regimens in clinical trials (platinum plus etoposide) and with topotecan; renewal language references ongoing myelosuppressive chemotherapy rather than a specific line.

Refer to cited clinical trials and NCCN compendium for context.

Background

Trilaciclib (Cosela) is an intravenous CDK4/6 inhibitor administered prior to myelosuppressive chemotherapy to provide prophylactic myelopreservation. Its clinical role is to temporarily arrest hematopoietic stem and progenitor cells in G1 phase before cytotoxic exposure, thereby reducing the incidence of chemotherapy-induced reductions in blood cell lineages. In this policy trilaciclib is indicated for reducing chemotherapy-induced myelosuppression in adults with ES-SCLC receiving the specified platinum/etoposide or topotecan-containing regimens.

Definitions

inv-14: Chemotherapy-Induced Myelosuppression — definition and relation to trilaciclib

DefinitionChemotherapy-induced myelosuppression: reduction in blood cell lineages due to cytotoxic chemotherapy, for which trilaciclib is used prophylactically to decrease the incidence.

Indication in this policyProphylactic therapy to decrease the incidence of chemotherapy-induced myelosuppression in patients with extensive-stage small cell lung cancer (ES-SCLC).

Covered chemotherapy regimensUsed when patient is undergoing myelosuppressive chemotherapy with either a platinum (carboplatin or cisplatin) plus etoposide–containing regimen OR a topotecan–containing regimen.

Supporting referencesPolicy references Cosela package insert and NCCN Compendium as sources for this indication.