vp-0532 - vp-0532 - Medical Policies
Trodelvy™ (sacituzumab govitecan-hziy) (Intravenous)
Policy Number: VP-0532
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
- Quantity Limit (max daily dose) [NDC Unit]:
- Trodelvy 180 mg vial – 12 vials every 21 days
- 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
Note: Patients that are homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele should be closely monitored for adverse reactions. |
† FDA approved indication(s), ‡ Compendia Recommended Indication(s); Ф Orphan Drug
*HER2-negative expression criteria: |
|
*ER/PR-negative expression criteria: |
Note: A sample may be deemed uninterpretable for ER or PR if the sample is inadequate (insufficient cancer or severe artifacts present, as determined at the discretion of the pathologist), if external and internal controls (if present) do not stain appropriately, or if pre-analytic variables have interfered with the assay’s accuracy. |
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
Indication |
Dose |
Breast Cancer |
Administer 10 mg/kg as an intravenous infusion once weekly on Days 1 and 8 of 21-day treatment cycles. Continue treatment until disease progression or unacceptable toxicity. Do not administer doses greater than 10 mg/kg. |
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
- Trodelvy [package insert]. Morris Plains, NJ; Immunomedics, Inc; April 2020. Accessed August 2020.
- 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.
- 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.
- 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.
- 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
- Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788.
- 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.
- 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.
- 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
ICD-10 |
ICD-10 Description |
C50.011 |
Malignant neoplasm of nipple and areola, right female breast |
C50.012 |
Malignant neoplasm of nipple and areola, left female breast |
C50.019 |
Malignant neoplasm of nipple and areola, unspecified female breast |
C50.021 |
Malignant neoplasm of nipple and areola, right male breast |
C50.022 |
Malignant neoplasm of nipple and areola, left male breast |
C50.029 |
Malignant neoplasm of nipple and areola, unspecified male breast |
C50.111 |
Malignant neoplasm of central portion of right female breast |
C50.112 |
Malignant neoplasm of central portion of left female breast |
C50.119 |
Malignant neoplasm of central portion of unspecified female breast |
C50.121 |
Malignant neoplasm of central portion of right male breast |
C50.122 |
Malignant neoplasm of central portion of left male breast |
C50.129 |
Malignant neoplasm of central portion of unspecified male breast |
C50.211 |
Malignant neoplasm of upper-inner quadrant of right female breast |
C50.212 |
Malignant neoplasm of upper-inner quadrant of left female breast |
C50.219 |
Malignant neoplasm of upper-inner quadrant of unspecified female breast |
C50.221 |
Malignant neoplasm of upper-inner quadrant of right male breast |
C50.222 |
Malignant neoplasm of upper-inner quadrant of left male breast |
C50.229 |
Malignant neoplasm of upper-inner quadrant of unspecified male breast |
C50.311 |
Malignant neoplasm of lower-inner quadrant of right female breast |
C50.312 |
Malignant neoplasm of lower-inner quadrant of left female breast |
C50.319 |
Malignant neoplasm of lower-inner quadrant of unspecified female breast |
C50.321 |
Malignant neoplasm of lower-inner quadrant of right male breast |
C50.322 |
Malignant neoplasm of lower-inner quadrant of left male breast |
C50.329 |
Malignant neoplasm of lower-inner quadrant of unspecified male breast |
C50.411 |
Malignant neoplasm of upper-outer quadrant of right female breast |
C50.412 |
Malignant neoplasm of upper-outer quadrant of left female breast |
C50.419 |
Malignant neoplasm of upper-outer quadrant of unspecified female breast |
C50.421 |
Malignant neoplasm of upper-outer quadrant of right male breast |
C50.422 |
Malignant neoplasm of upper-outer quadrant of left male breast |
C50.429 |
Malignant neoplasm of upper-outer quadrant of unspecified male breast |
C50.511 |
Malignant neoplasm of lower-outer quadrant of right female breast |
C50.512 |
Malignant neoplasm of lower-outer quadrant of left female breast |
C50.519 |
Malignant neoplasm of lower-outer quadrant of unspecified female breast |
C50.521 |
Malignant neoplasm of lower-outer quadrant of right male breast |
C50.522 |
Malignant neoplasm of lower-outer quadrant of left male breast |
C50.529 |
Malignant neoplasm of lower-outer quadrant of unspecified male breast |
C50.611 |
Malignant neoplasm of axillary tail of right female breast |
C50.612 |
Malignant neoplasm of axillary tail of left female breast |
C50.619 |
Malignant neoplasm of axillary tail of unspecified female breast |
C50.621 |
Malignant neoplasm of axillary tail of right male breast |
C50.622 |
Malignant neoplasm of axillary tail of left male breast |
C50.629 |
Malignant neoplasm of axillary tail of unspecified male breast |
C50.811 |
Malignant neoplasm of overlapping sites of right female breast |
C50.812 |
Malignant neoplasm of overlapping sites of left female breast |
C50.819 |
Malignant neoplasm of overlapping sites of unspecified female breast |
C50.821 |
Malignant neoplasm of overlapping sites of right male breast |
C50.822 |
Malignant neoplasm of overlapping sites of left male breast |
C50.829 |
Malignant neoplasm of overlapping sites of unspecified male breast |
C50.911 |
Malignant neoplasm of unspecified site of right female breast |
C50.912 |
Malignant neoplasm of unspecified site of left female breast |
C50.919 |
Malignant neoplasm of unspecified site of unspecified female breast |
C50.921 |
Malignant neoplasm of unspecified site of right male breast |
C50.922 |
Malignant neoplasm of unspecified site of left male breast |
C50.929 |
Malignant neoplasm of unspecified site of unspecified male breast |
Z85.3 |
Personal history of malignant neoplasm of breast |
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
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
||
Jurisdiction |
Applicable State/US Territory |
Contractor |
E (1) |
CA, HI, NV, AS, GU, CNMI |
Noridian Healthcare Solutions, LLC |
F (2 & 3) |
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ |
Noridian Healthcare Solutions, LLC |
5 |
KS, NE, IA, MO |
Wisconsin Physicians Service Insurance Corp (WPS) |
6 |
MN, WI, IL |
National Government Services, Inc. (NGS) |
H (4 & 7) |
LA, AR, MS, TX, OK, CO, NM |
Novitas Solutions, Inc. |
8 |
MI, IN |
Wisconsin Physicians Service Insurance Corp (WPS) |
N (9) |
FL, PR, VI |
First Coast Service Options, Inc. |
J (10) |
TN, GA, AL |
Palmetto GBA, LLC |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA, LLC |
L (12) |
DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) |
Novitas Solutions, Inc. |
K (13 & 14) |
NY, CT, MA, RI, VT, ME, NH |
National Government Services, Inc. (NGS) |
15 |
KY, OH |
CGS Administrators, LLC |