Overview

This document addresses the use of Trodelvy (sacituzumab govitecan). Trodelvy is a Trop-2-directed antibody and topoisomerase inhibitor conjugate primarily used to treat breast cancer. The FDA approved indications for Trodelvy is the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.

Trodelvy (sacituzumab govitecan) is also FDA approved for the treatment of adults with 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 (PD-L1) inhibitor.

The National Comprehensive Cancer Network® (NCCN) also provides an additional recommendation with a category 2A level of evidence for the use of Trodelvy in recurrent, triple-negative breast cancer.

Breast cancer is one of the most common forms of cancer in the United States. Metastatic triple-negative breast cancer (TNBC) accounts for about 15% of invasive breast cancer. TNBC refers to breast cancer that does not express estrogen receptor (ER), progesterone receptor (PR), or overexpression of human epidermal growth factors receptor 2 (HER2), making it more difficult to treat and associated with a poor prognosis.

Trodelvy is the first Trop-2-directed antibody-drug conjugate, and the first targeted therapy approved for TNBC. Although Trodelvy consists, in part, of an active metabolite (SN-38) of the drug irinotecan, the FDA label warns against substituting it with irinotecan or using it in a regimen that already contains irinotecan or SN-38. Trodelvy has a black box warning for causing severe neutropenia and diarrhea.

Withholding Trodelvy for absolute neutrophil count below 1500/mm3 or neutropenic fever is recommended. Monitoring patients for diarrhea, and providing supportive care if needed are also recommended, in addition to withholding or reducing dose for severe diarrhea.

Definitions and Measures

• Disease Progression: Cancer that continues to grow or spread.
• Immune checkpoint inhibitor: A type of drug that blocks certain proteins made by some types of immune system cells, such as T cells, and some cancer cells. When these proteins are blocked, the "brakes" on the immune system are released and T cells are able to kill cancer cells better. Examples of checkpoint proteins found on T cells or cancer cells include programmed death (PD)-1, PD-ligand 1 (PD-L1), and cytotoxic T-lymphocyte–associated antigen (CTLA)-4/B7-1/B7-2.
• Metastasis: The spread of cancer from one part of the body to another. A metastatic tumor contains cells that are like those in the original (primary) tumor and have spread.
• Programmed death (PD)-1 proteins: PD-1 proteins are found on T-cells and attach to PD ligands (PD-L1) found on normal (and cancer) cells (see immune checkpoint inhibitor above). Normally, this process keeps T-cells from attacking other cells in the body. However, this can also prevent T-cells from attacking cancer cells in the body. Examples of FDA approved anti-PD-1 agents include Keytruda (pembrolizumab), Opdivo (nivolumab), and Libtayo (cemiplimab).
• Programmed death ligand (PD-L)-1: The ligands found on normal (and cancer) cells to which the PD-1 proteins attach (see immune checkpoint inhibitor above). Cancer cells can have large amounts of PD-L1 on their surface, which helps them to avoid immune attacks. Examples of FDA approved anti-PD-L1 agents include Bavencio (avelumab), Tecentriq (atezolizumab), and Imfinzi (durvalumab).

Clinical Criteria

When a drug is being reviewed for coverage under a member’s medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.

Trodelvy (sacituzumab govitecan)

Requests for Trodelvy (sacituzumab govitecan) may be approved if the following criteria are met (Label, NCCN 2A):

1. Individual has recurrent or metastatic, histologically confirmed triple-negative Breast Cancer (lack of estrogen- and progesterone-receptor expression and no overexpression of HER2); AND
2. Individual has confirmation of disease progression after two prior lines of therapies;
3. OR Individuals have unresectable, locally advanced or metastatic, histologically confirmed hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)- negative breast cancer; AND
4. Individual has received endocrine based therapy; AND
5. Individual has confirmation of disease progression after two prior lines of therapies;
6. OR Individual has no response to preoperative systemic therapy or recurrent unresectable breast cancer (NCCN 1); AND
7. Individual is using as second-line;
8. Individual has locally advanced or metastatic Urothelial Cancer; AND
9. Individual has confirmation of disease progression after platinum-containing chemotherapy and either an anti-PD-1 or anti-PD-L1 agent.

Trodelvy (sacituzumab govitecan) may not be approved for the following:

• Individual is using in combination with an irinotecan-containing regimen or its SN-38 metabolite; OR
• When the above criteria are not met and for all other indications.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

J9317

ICD-10 Diagnosis

Injection, sacituzumab govitecan-hziy, 2.5 mg [Trodelvy]

C50.011-C50.929 Malignant neoplasm of breast

C68.0-C68.9 Malignant neoplasm of overlapping sites of urinary organs

C79.81-C79.89 Secondary malignant neoplasm of other and unspecified sites

D05.00-D05.92 Carcinoma in situ of breast

Z85.3 Personal history of malignant neoplasm of breast

Z17.1 Estrogen receptor negative status [ER-]

Document History

Revised: 08/18/2023