WHA

TRODELVY (sacituzumab govitecan-hziy)

OFFICE ADMINISTRATION – INTRAVENOUS (IV)

Indication for Prior Authorization:

Treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.

Coverage Criteria:
  • Diagnosis of mTNBC; AND
  • Prescribed by or in consultation with an oncologist; AND
  • Patient has been treated with at least two prior systemic therapies for mTNBC; AND
  • Dose does not exceed 10 mg/kg on days 1 and 8 of every 21-day cycle.
Dosing:

Administer Trodelvy up to 10 mg/kg intravenous (IV) infusion on Days 1 and 8 of every 21-day treatment cycle.

Coverage Duration:

1 year.

Authorization is Not Covered for the following:

Non-FDA approved indications that are not listed in this policy do not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Review History:

10/10/2020 – New policy.

References:
  • Anders CK and Carey LA. ER/PR negative, HER2-negative (triple-negative) breast cancer. UpToDate Web site. Updated May 28, 2020. www.uptodate.com. Accessed June 8, 2020.
  • Bardia A, Mayer IA, Vahdet LT, et al. Sacituzumab govitecan-hziy in refractory metastatic triple-negative breast cancer. N Engl J Med. 2019;380:741-751.
  • Bardia A, Rugo RS, Horne H, et al. A phase III, randomized trial of sacituzumab govitecan (IMMU-132) vs treatment of physician choice (TPC) for metastatic triple-negative breast cancer (mTNBC). Cancer Res. 2018;78 (4 Supplement): OT2-07-05. https://cancerres.aacrjournals.org/content/78/4_Supplement/OT2-07-05. Accessed June 8, 2020.
  • Clinicaltrials.gov. [NCT01631552]. https://clinicaltrials.gov/ct2/show/NCT01631552?term=nCT01631552&draw=2&rank=1. Accessed June 8, 2020.
  • Clinicaltrials.gov. [NCT02574455]. https://clinicaltrials.gov/ct2/show/NCT02574455?term=NCT02574455&draw=2&rank=1. Accessed June 8, 2020.
  • Cortes J, O’Shaughnessy J, Loesch D, et al. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomized study. Lancet. 2011;377:914-923.
  • Food and Drug Administration. Trodelvy summary review. November 30, 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761115Orig1s000TOC.cfm. Accessed June 8, 2020.
  • Food and Drug Administration. FDA grants accelerated approval to sacituzumab govitecan-hziy for metastatic triple negative breast cancer. Press release. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-sacituzumab-govitecan-hziy-metastatic-triple-negative-breast-cancer. Accessed June 8, 2020.
  • Immunomedics. Publications. Web site. https://www.immunomedics.com/our-science/publications/. Accessed June 8, 2020.
  • Immunomedics. Immunomedics announces ASCENT study to be stopped for compelling efficacy. Press release. April 6, 2020. https://www.immunomedics.com/our-company/news-and-events/immunomedics-announces-ascent-study-to-be-stopped-for-compelling-efficacy/. Accessed June 8, 2020.
  • Kassam F, Enright K, Dent R, et al. Survival outcomes for patients with metastatic triple-negative breast cancer: implications for clinical practice and trial design. Clin Breast Cancer. 2009 Feb;9(1):29-33.
  • Li J, Ren J, Sun W. Systematic review of Ixabepilone for treating metastatic breast cancer. Breast Cancer. 2017 Mar;24(2):171.
  • National Cancer Institute (NCI): Surveillance, Epidemiology, and End Results Program (SEER). Cancer stat facts: Female breast cancer subtypes. Web site. 2020. https://seer.cancer.gov/statfacts/html/breast-subtypes.html. Accessed June 8, 2020.
  • National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Breast cancer. V4.2020 – May 8, 2020. NCCN Web site. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed June 8, 2020.
  • Oken M, Creech R, Tormey D, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655.
  • Perez EA, Lerzo G, Pivot X, et al. Efficacy and safety of ixabepilone in a phase 2 study of patients with advanced breast cancer resistant to an anthracycline, a taxane, and capecitabine. J Clin Oncol. 2007;25:3407-3414.
  • Slater H. Phase III ASCENT study of metastatic TNBC halted due to compelling efficacy. Cancer Network, home of the journal Oncology. April 10, 2020. https://www.cancernetwork.com/breast-cancer/phase-iii-ascent-study-metastatic-tnbc-halted-due-compelling-efficacy. Accessed June 8, 2020.
  • Trivers KF, Lund MJ, Porter PL, et al. The epidemiology of triple-negative breast cancer, including race. Cancer Causes Control. 2009;20:1071.
  • Trodelvy [package insert], Morris Plains, NJ: Immunomedics, Inc; April 2020.
  • Wolff AC, Hammond MEH, Hicks DG, et al. Recommendations for Human Epidermal Growth Factor Receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013;31(31):3997. Epub 2013 Oct 7.