When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.
Sacituzumab govitecan-hziy (TrodelvyTM) is considered medically necessary and, therefore, covered for continuation therapy until disease progression, drug intolerance, or unacceptable toxicity.
NOT MEDICALLY NECESSARY
When FDA-approved diagnostic tests do not reveal triple-negative (ER-/PR-/HER2-) breast cancer, sacituzumab govitecan-hziy (TrodelvyTM) is considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the treatment of those diseases.
Triple-negative breast cancer (TNBC) accounts for about 10-15% of all breast cancers. TNBC lack receptors for estrogen, progesterone, and HER2 and don’t respond to drugs that target estrogen, progesterone, or HER2 receptors. Triple-negative breast cancer differs from other types of invasive breast cancer in that they grow and spread faster, have limited treatment options, and a worse prognosis. These cancers tend to be more common in women younger than age 40, who are African-American, or who have a BRCA1 mutation.
DIAGNOSTIC TESTS FOR HER2 PROTEIN EXPRESSION TESTING
HER2 protein overexpression is detected either by immunohistochemical (IHC) assay that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample or with a type of in situ hybridization (ISH) test for gene amplification (e.g., fluorescence in situ hybridization [FISH], chromogenic in situ hybridization [CISH], dual in situ hybridization [DISH]). The FDA has approved several commercially available tests to aid in the selection of breast cancer individuals for fam-trastuzumab deruxtecan-nxki (Enhertu®) therapy. The National Comprehensive Cancer Network (NCCN) and American Society of Clinical Oncology (ASCO) guidelines (2018) further recommend that IHC assay and ISH testing should only be done at laboratories that are accredited to perform HER2 testing.
A total of 108 individuals received sacituzumab govitecan-hziy at a dose of 10 mg per kilogram of body weight after receiving at least two previous anticancer therapies for metastatic triple-negative breast cancer. The primary efficacy end point was the objective response rate. The secondary end points were the time to response and the duration of response and progression-free and overall survival. Safety evaluations included assessments of adverse events, change in a laboratory values, vital signs, physical examination, and 12-lead electrocardiography (ECG). The response rate was 33.3% (36 of 108 individuals), including complete responses in 3 individuals (2.8%). The clinical benefit rate (including stable disease for at least 6 months) was 45.4% (49 of 108 individuals). At the time of data cutoff, 94 individuals (87.0%) had disease progression and 77 individuals (71.3%) had died. The median progression-free survival was 5.5 months (95% CI, 4.1 to 6.3); the estimated probability of progression-free survival was 41.9% at 6 months and 15.1% at 12 months. The median overall survival was 13.0 months (95% CI, 11.2 to 13.7); the estimated probability of survival was 78.5% at 6 months and 51.3% at 12 months. Among individuals with metastatic triple-negative breast cancer who had received at least two previous therapies for metastatic disease (median, three) and who received treatment with sacituzumab govitecan-hziy, the response rate was 33.3%, the median duration of response was 7.7 months, the median progression-free survival was 5.5 months, and the median overall survival was 13.0 months. The duration of treatment with sacituzumab govitecan-hziy was longer than with the immediate previous antitumor therapy (5.1 months vs. 2.5 months).
The most common adverse events were nausea, diarrhea, fatigue, neutropenia, and anemia, and the most common adverse events of grade 3 or higher (>5% incidence) included neutropenia, anemia, and a decreased white-cell count.
A confirmatory multicenter, randomized, phase 3 trial (ASCENT; ClinicalTrials.gov number, NCT02574455) is currently recruiting individuals to compare sacituzumab govitecan-hziy with the provider’s choice of four single-agent types of chemotherapy (capecitabine, gemcitabine, vinorelbine, and eribulin) in individuals with metastatic triple-negative breast cancer that is refractory or relapsed after at least two previous forms of chemotherapy (including a taxane).
There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP). Estrogen and Progesterone Receptor Testing in Breast Cancer: ASCO/CAP Clinical Practice Guideline Update. [CAP Web site]. 05/2020. Available at: https://www.archivesofpathology.org/doi/pdf/10.5858/arpa.2019-0904-SA. Accessed May 06, 2020.
Bardia A , Mayer IA, Vahdat LT, et al. Sacituzumab govitecan-hziy in refractory metastatic triple-negative breast cancer. New Engl J Med.2019;380:741-51.
ClinicalTrials.gov. Phase I/II Study of IMMU-132 in Patients With Epithelial Cancers. ClinicalTrials.gov Identifier: NCT01631552. First Posted: June 29, 2012; Last Update Posted: November 22, 2019. Available at: https://clinicaltrials.gov/ct2/show/record/NCT01631552. Accessed May 06, 2020.
ClinicalTrials.gov. ASCENT-Study of Sacituzumab Govitecan in Refractory/Relapsed Triple-Negative Breast Cancer (ASCENT). ClinicalTrials.gov Identifier: NCT02574455. First Posted: October 12, 2015; Last Update Posted: February 11, 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02574455 . Accessed May 06, 2020.
Elsevier’s Clinical Pharmacology Compendium .Sacituzumab govitecan-hziy (TrodelvyTM).[Clinical Key Web site]. 04/28/20. Available at: https://www.clinicalkey.com/#!/ [via subscription only]. Accessed May 06, 2020.
Lexi-Drugs Compendium. Sacituzumab govitecan-hziy. [Lexicomp Online Web site]. 05/05/2020. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed May 06, 2020.
Sacituzumab govitecan-hziy (TrodelvyTM) [prescribing information]. Morris Plains, NJ: Immunomedics, Inc.; 2020. Available at: https://trodelvy.com/prescribing-information. Accessed May 06, 2020.
Truven Health Analytics. Micromedex® DrugDex® Compendium. Sacituzumab govitecan-hziy (TrodelvyTM). Greenwood Village, CO. [Micromedex® Solutions Web site]. 04/23/2020. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed May 06, 2020.
US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs@FDA. Sacituzumab govitecan-hziy (TrodelvyTM). [FDA Web site]. Original: 04/22/20. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm . Accessed May 06, 2020.
US Food and Drug Administration (FDA). Devices @ FDA (HER2). Available at: http://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm. Accessed April 17, 2019.
US Food and Drug Administration (FDA). Fam-trastuzumab deruxtecan-nxki (Enhertu ®) prescribing information & approval letter. [FDA Web site]. 04/2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761115s000lbl.pdf. Accessed May 06, 2020.
Policy: 07.00.20f:Routine Costs Associated with Qualifying Clinical Trials
Policy: 08.00.15f:Off-label Coverage for Prescription Drugs and/or Biologics