Last Review Date: 09/01/2020

Date of Origin: 02/04/2020

Dates Reviewed: 02/2020, 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]:

• Enhertu 100 mg vial – 6 vials every 21 days 

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

• 600 billable units every 21 days

III. Initial Approval Criteria 

Coverage is provided in the following conditions:

• Patient at least 18 years of age; AND

Universal Criteria 

• Left ventricular ejection fraction (LVEF) is within normal limits prior to initiating therapy and will be assessed at regular intervals (e.g., every 3 months) during treatment; AND
• Patient has human epidermal growth factor receptor 2 (HER2)-positive* disease; AND
• Used as single agent therapy; AND
• Therapy will not be substituted with or for any trastuzumab-based formulation (i.e., trastuzumab [or trastuzumab biosimilar product], ado-trastuzumab emtansine, trastuzumab-hyaluronidase, pertuzumab/trastuzumab and hyaluronidase-zzxf, etc.); AND

Breast Cancer † 

• Patient has unresectable or metastatic disease; AND
• Patient has previously been treated with at least two (2) prior HER2-targeted therapies for metastatic disease

† FDA approved indication(s); ‡ Compendia Recommended Indication(s)

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: left ventricular dysfunction/symptomatic congestive heart failure, pulmonary toxicity (i.e., interstitial lung disease/pneumonitis), neutropenia/febrile neutropenia, etc.; AND
  • LVEF is > 45% and absolute decrease is ≤ 20% from baseline (LVEF results must be within the previous 3 months); OR
  • LVEF is 40% to 45% and absolute decrease is < 10% from baseline (LVEF results must be within the previous 3 months)

V. Dosage/Administration

VI. Billing Code/Availability Information

HCPCS Code:

• J9358 - Injection, fam-trastuzumab deruxtecan-nxki, 1 mg: 1 billable unit = 1 mg

NDC:

• Enhertu 100 mg single-use vial: 65597-0406-xx 

VII. References

1. Enhertu [package insert]. Basking Ridge, NJ; Daiichi Sankyo, Inc; December 2019. Accessed August 2020.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) fam-trastuzumab deruxtecan. 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. 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.

4. 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.
5. 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.
6. 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
7. Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788.
8. Modi S, Saura C, Yamashita T, et al; DESTINY-Breast01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer. N Engl J Med. 2019 Dec 11. doi: 10.1056/NEJMoa1914510.
9. First Coast Service Options, Inc. Local Coverage Article: Billing and Coding: Trastuzumab -Trastuzumab Biologics (A56660). Centers for Medicare & Medicaid Services, Inc. Updated on 7/22/2020 with effective date of 7/1/2020. Accessed August 2020.

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 Local Coverage Articles (LCAs) 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/LCA):