Last Review Date: 09/01/2020

Date of Origin: 06/02/2020

Dates Reviewed: 06/2020, 09/2020

I. Length of Authorization

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

II. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Trodelvy 180 mg vial – 12 vials every 21 days 

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

• 108 billable units weekly for two doses every 21 days

III. Initial Approval Criteria 

Coverage is provided in the following conditions:

• Patient at least 18 years of age; AND

Universal Criteria

• 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 single agent therapy; AND

Breast Cancer † ‡ 

• Patient has recurrent or metastatic disease; AND
• Patient has unequivocal triple-negative disease [TNBC] (i.e., estrogen, progesterone, and HER2-negative)*; AND
• Patient was previously treated with at least two systemic therapies for metastatic disease including

† FDA approved indication(s), ‡ Compendia Recommended Indication(s); Ф Orphan Drug

IV. Renewal Criteria 

Coverage can be renewed based upon the following criteria:

• Patient continues to meet 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 the following: severe hypersensitivity, severe nausea/vomiting, severe neutropenia/febrile neutropenia, severe diarrhea, etc.

V. Dosage/Administration

VI. Billing Code/Availability Information

HCPCS Code:

• J9999 – Not otherwise classified, antineoplastic drugs
• C9066 – Injection, sacituzumab govitecan-hziy, 2.5 mg; 1 billable unit=10 mg (HOPPS-Hospital Outpatient Prospective Payment System Use Only) (Effective 10/1/20)

NDC:

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

VII. References

1. Trodelvy [package insert].  Morris Plains, NJ; Immunomedics, Inc; April 2020. Accessed August 2020.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) sacituzumab govitecan. National Comprehensive Cancer Network, 2020. 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 August 2020.
3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Breast Cancer 5.2020. National Comprehensive Cancer Network, 2020. 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 August 2020.
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.

Appendix 1 – Covered Diagnosis Codes

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

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 Determination (NCD), Local Coverage Determinations (LCDs) and Articles may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

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