Trilaciclib (Cosela)

Policy ID: I-239-006

Section: Injections

Effective Date: June 01, 2021

Revised Date: July 09, 2024

Revision Effective Date: September 01, 2024

Last Reviewed: July 16, 2024

Applies To: Commercial and Medicaid Expansion

Description

Trilaciclib (Cosela ^TM ) is a cyclin-dependent kinases (CDK) 4/6 inhibitor. Hematopoietic stem and progenitor cells (HSPCs) in the bone marrow give rise to circulating neutrophils, RBCs, and platelets. HSPC proliferation is dependent on CDK 4/6 activity.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Trilaciclib (Cosela) may be considered medically necessary for individuals 18 years of age or older when the following criteria are met:

Individual diagnosed with extensive-stage small cell lung cancer (ES-SCLC); and
Platinum/etoposide-containing regimen or topotecan containing regimen is planned; and
Trilaciclib (Cosela) will be used to decrease the incidence of chemotherapy-induced myelosuppression.

Compendia Sources

Trilaciclib (Cosela) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of trilaciclib (Cosela) for any other indication than listed above is considered experimental/investigational and therefore, not covered. The safety and/or efficacy cannot be established by review of the available published peer-reviewed literature.

Procedure Code

J1448

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

C34.00

C34.01

C34.02

C34.10

C34.11

C34.12

C34.2

C34.30

C34.31

C34.32

C34.80

C34.81

C34.82

C34.90

C34.91

C34.92

D61.810

D64.81

D70.1

D70.9

T45.1X5A

T45.1X5D

T45.1X5S

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 5-20-2021 Adopted new pre-certification drug policy effective 6-1-2021

Internal Medical Policy Committee 7-22-2021 Effective July 01, 2021

Added new code C9078 to policy

Internal Medical Policy Committee 9-21-2021- Effective October 01, 2021

Added new code J1448 to the policy, and
Removed C9078

Internal Medical Policy Committee 7-21-2022

Added additional diagnosis codes, and
Removed diagnosis code Z51.11, and
Removed NCCN recommendations and
Added this statement 'Trilaciclib (Cosela) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.' and
Updated the experimental/investigational statement

Internal Medical Policy Committee 7-26-2023 Annual review, no clinical content change

Internal Medical Policy Committee 7-16-2024 Effective September 01, 2024

Annual review no clinical content change

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-239-005

Section: Injections

Effective Date: June 01, 2021

Revised Date: July 05, 2022

Revision Effective Date: September 01, 2022

Last Reviewed: July 26, 2023

Archived Date: August 31, 2024

Applies To: Commercial and Medicaid Expansion

Description

Trilaciclib (Cosela^TM) is a cyclin-dependent kinases (CDK) 4/6 inhibitor. Hematopoietic stem and progenitor cells (HSPCs) in the bone marrow give rise to circulating neutrophils, RBCs, and platelets. HSPC proliferation is dependent on CDK 4/6 activity.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Trilaciclib (Cosela) may be considered medically necessary for individuals 18 years of age or older when the following criteria are met:

Individual diagnosed with extensive-stage small cell lung cancer (ES-SCLC); and
Platinum/etoposide-containing regimen or topotecan containing regimen is planned; and
Trilaciclib (Cosela) will be used to decrease the incidence of chemotherapy-induced myelosuppression.

Compendia Sources

Trilaciclib (Cosela) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

Procedure Codes

J1448

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

C34.00

C34.01

C34.02

C34.10

C34.11

C34.12

C34.2

C34.30

C34.31

C34.32

C34.80

C34.81

C34.82

C34.90

C34.91

C34.92

D61.810

D64.81

D70.1

D70.9

T45.1X5A

T45.1X5D

T45.1X5S

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 5-20-2021 Adopted new pre-certification drug policy effective 6-1-2021

Internal Medical Policy Committee 7-22-2021 Effective July 01, 2021

Added new code C9078 to policy

Internal Medical Policy Committee 9-21-2021- Effective October 01, 2021

Added new code J1448 to the policy, and
Removed C9078

Internal Medical Policy Committee 7-21-2022

Added additional diagnosis codes, and
Removed diagnosis code Z51.11, and
Removed NCCN recommendations and
Added this statement "Trilaciclib (Cosela) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations." and
Updated the experimental/investigational statement

Internal Medical Policy Committee 7-26-2023 Annual review, no clinical content change

Medical Policies Quick Search

Trilaciclib (Cosela)

Description

Policy Application

Criteria

Procedure Code

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Criteria

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer