Last Review Date: 01/06/2025

Date of Origin: 06/02/2020

Dates Reviewed: 06/2020, 09/2020, 01/2021, 05/2021, 03/2022, 03/2023, 03/2024, 01/2025

1. Length of Authorization

Coverage will be provided for 6 months and may be renewed.

2. Dosing Limits

Max Units (per dose and over time) [HCPCS Unit]:

• 864 billable units every 21 days

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria ¹

• Therapy will NOT be substituted for or used in combination with irinotecan; AND
• Therapy will not be used in combination with UGT1A1 inhibitors (e.g., nilotinib, regorafenib, etc.) or inducers (e.g., phenytoin, carbamazepine, etc.); AND
• Used as a single agent; AND

Breast Cancer † ‡ ^1-3

• Patient has triple-negative breast cancer [TNBC] Ψ (i.e., estrogen, progesterone, and HER2-negative); AND
  • Patient has unresectable locally advanced disease; AND
    • Patient was previously treated with at least two systemic therapies, at least one of them for metastatic disease; OR
  • Patient has recurrent unresectable or metastatic disease OR inflammatory breast cancer with no response to preoperative systemic therapy; AND
    • Patient was previously treated with at least one prior therapy for metastatic disease; OR
• Patient has hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative disease*; AND
  • Patient has unresectable locally advanced, or metastatic disease; AND
    • Patient was previously treated with endocrine therapy and at least two additional lines of systemic therapy for metastatic disease; OR
  • Patient has recurrent unresectable disease OR inflammatory breast cancer with no response to preoperative systemic therapy ‡; AND
    • Patient has received prior treatment including endocrine therapy, a CDK4/6 inhibitor (e.g., palbociclib, ribociclib, abemaciclib, etc.), and at least two lines of chemotherapy (including a taxane) at least one of which was in the metastatic setting; AND
    • Patient is not a candidate for fam-trastuzumab deruxtecan

Urothelial Cancer (Bladder Cancer) ‡ ^2,10

• Patient has one of the following diagnoses:
  • Locally advanced or metastatic urothelial carcinoma ; OR
  • Muscle invasive bladder cancer with local recurrence or persistent disease in a preserved bladder treated with curative intent; OR
  • Metastatic or local bladder cancer recurrence post-cystectomy treated with curative intent ‡; OR
  • Primary carcinoma of the urethra; AND
    • Used for recurrent (excluding recurrence of stage T3-4 disease or palpable inguinal lymph nodes) or metastatic disease; OR
  • Metastatic upper genitourinary (GU) tract tumors; OR
  • Metastatic urothelial carcinoma of the prostate; AND

• Patient was previously treated with platinum-containing chemotherapy** and programmed death (PD-1 or PD-L1)-directed therapy (e.g., avelumab, nivolumab, atezolizumab, durvalumab, etc.)

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe hypersensitivity and infusion-related reactions (including anaphylactic reactions), severe nausea/vomiting, severe neutropenia/febrile neutropenia, severe anemia, severe diarrhea, etc.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J9317 – Injection, sacituzumab govitecan-hziy, 2.5 mg; 1 billable unit = 2.5 mg

NDC:

• Trodelvy 180 mg lyophilized powder in a single-dose vial: 55135-0132-xx 

7. References

1. Trodelvy [package insert]. Foster City, CA; Gilead Sciences, Inc.; November 2024. Accessed December 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) sacituzumab govitecan. National Comprehensive Cancer Network, 2024. The NCCN Compendium^® is a derivative work of the NCCN Guidelines^®. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES^® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed December 2024.
3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Breast Cancer 6.2024. National Comprehensive Cancer Network, 2024. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed December 2024.
4. Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018 Mar;14(3):e130-e136.
5. Hematology/Oncology Pharmacy Association (2019). Intravenous Cancer Drug Waste Issue Brief. Retrieved from http://www.hoparx.org/images/hopa/advocacy/Issue-Briefs/Drug_Waste_2019.pdf
6. Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788.
7. Bardia A, Mayer IA, Vahdat LT, et al. Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2019 Feb 21;380(8):741-751. doi: 10.1056/NEJMoa1814213.
8. Wolff AC, Hammond EH, Allison KH, et al. Human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. J Clin Oncol 2018;36:2105-2122.
9. Allison KH, Hammond EH, Dowsett M, et al. Estrogen and Progesterone Receptor Testing in Breast Cancer: ASCO/CAP Guideline Update. J Clin Oncol 38:1346-1366.
10. Tagawa S, Balar A, Petrylak, et al. TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors. J Clin Oncol. 2021 Aug 1;39(22):2474-2485. doi: 10.1200/JCO.20.03489. Epub 2021 Apr 30.
11. Rugo HS, Bardia A, Marme F, et al. Sacituzumab Govitecan in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer. J Clin Oncol. 2022 Oct 10;40(29):3365-3376. doi: 10.1200/JCO.22.01002. Epub 2022 Aug 26.
12. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Bladder Cancer. Version 5.2024. National Comprehensive Cancer Network, 2024. The NCCN Compendium^® is a derivative work of the NCCN Guidelines^®. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed December 2024.
13. Bellmunt, J. (2024). Treatment of metastatic urothelial cancer of the bladder and urinary tract. In Lerner SP, Shah S (Eds.), UptoDate. Last updated: February 7, 2024. Accessed February 20, 2024. Available from https://www.uptodate.com/contents/treatment-of-metastatic-urothelial-cancer-of-the-bladder-and-urinary-tract?search=cisplatin%20ineligible&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1.
14. Gupta S, Bellmunt J, Plimack ER, et al. Defining “platinum-ineligible” patients with metastatic urothelial cancer (mUC). J Clin Oncol. 2022 June 1;40(16_suppl):4577.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A