Sacituzumab govitecan-hziy (Trodelvy) (ARCHIVED)

Policy ID: I-223-007

Section: Injections

Effective Date: April 01, 2020

Revised Date: October 24, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-223-007

Section: Injections

Effective Date: April 01, 2020

Revised Date: October 24, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Sacituzumab govitecan-hziy (Trodelvy™) is a Trop-2 directed antibody and topoisomerase inhibitor conjugate composed of humanized monoclonal antibody sacituzumab, the drug SN-38, and a hydrolysable linker. Sacituzumab govitecan (Trodelvy) binds to Trop-2-expressing cancer cells and is internalized with subsequent release of SN-38 which interacts with topoisomerase I causing DNA damage resulting in cell apoptosis.

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.

Sacituzumab govitecan (Trodelvy) may be considered medically necessary in individuals 18 years of age and older for the following conditions:

Breast Cancer

As treatment for metastatic triple-negative breast cancer (mTNBC) in individuals who have received at least two prior therapies for metastatic disease; or
As treatment for unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine- based therapy and at least two additional systemic therapies in the metastatic setting; or

Bladder Cancer

As a treatment for locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PDL1) inhibitor ; or

Compendia Sources

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

The use of sacituzumab govitecan (Trodelvy) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J9317

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

Covered Diagnosis Codes for Procedure Code J9317

C50.011

C50.012

C50.019

C50.021

C50.022

C50.029

C50.111

C50.112

C50.119

C50.121

C50.122

C50.129

C50.211

C50.212

C50.219

C50.221

C50.222

C50.229

C50.311

C50.312

C50.319

C50.321

C50.322

C50.329

C50.411

C50.412

C50.419

C50.421

C50.422

C50.429

C50.511

C50.512

C50.519

C50.521

C50.522

C50.529

C50.611

C50.612

C50.619

C50.621

C50.622

C50.629

C50.811

C50.812

C50.819

C50.821

C50.822

C50.829

C50.911

C50.912

C50.919

C50.921

C50.922

C50.929

C61

C65.1

C65.2

C65.9

C66.1

C66.2

C66.9

C67.0

C67.1

C67.2

C67.3

C67.4

C67.5

C67.6

C67.7

C67.8

C67.9

C68.0

D09.0

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 7-22-2020 Adopted policy

Internal Medical Policy Committee 9-21-2020

Added new code C9066 to policy

Internal Medical Policy Committee 1-19-2021- Effective January 01, 2021

Added new code J9317, and
Removed code C9066 from policy

Internal Medical Policy Committee 7-22-2021

Updated FDA indications, NCCN recommendations, and
Updated diagnosis codes

Internal Medical Policy Committee 7-21-2022 Annual review, no clinical content change

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

Internal Medical Policy Committee 9-12-2023 - Effective November 01, 2023

Updated breast cancer criteria
Removed NCCN recommendations
Added Compendia sources statement 'Drug may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.'
Updated experimental/investigational statement
Removed diagnosis codes Z85.3, Z85.51 and Z85.59

Internal Medical Policy Committee 9-17-2024 Effective November 01, 2024

Annual review no clinical content change

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

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.

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