Last Review Date: 12/01/2020

Date of Origin: 05/16/2013

Dates Reviewed: 07/2013, 11/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 09/2018, 12/2018, 03/2019, 04/2019, 06/2019, 9/2019, 12/2019, 03/2020, 06/2020, 09/2020, 12/2020

I. Length of Authorization 

Coverage will be provided for six months and may be renewed unless otherwise specified.

• Use as adjuvant treatment of HER2-positive disease in patients with locally advanced or early breast cancer with residual disease is limited to 14 cycles (42 weeks total).

II. Dosing Limits

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

• Kadcyla 100 mg vial – 1 vial every 21 days 
• Kadcyla 160 mg vial – 3 vials every 21 days

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

• 480 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 as determined by an FDA-approved or CLIA-compliant testv; 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], fam-trastuzumab deruxtecan-nxki, trastuzumab-hyaluronidase, pertuzumab/trastuzumab and hyaluronidase-zzxf, etc.); AND

Breast Cancer † 

• Used as adjuvant therapy in patients with:
  • Locally advanced residual or node positive disease following completion of planned chemotherapy and mastectomy or lumpectomy ‡; OR
  • Early breast cancer with residual invasive disease after neoadjuvant taxane and trastuzumab-based therapy; OR
• Patient has metastatic or recurrent disease

Non-Small Cell Lung Cancer ‡ 

v If confirmed using an immunotherapy assay-http://www.fda.gov/companiondiagnostics

† 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: hepatotoxicity, left ventricular dysfunction, pulmonary toxicity (i.e., interstitial lung disease, pneumonitis), thrombocytopenia, neurotoxicity, infusion-related and hypersensitivity reactions, hemorrhage, extravasation at infusion site, etc.; AND

Non-Small Cell Lung Cancer:

• Left ventricular ejection fraction (LVEF) is ≥ 50% OR LVEF is ≥45% and absolute decrease is <10% from baseline (LVEF results must be within the previous 3 months)

Metastatic or Recurrent Breast Cancer:

• • Left ventricular ejection fraction (LVEF) is >45% OR LVEF is ≥40% and absolute decrease is <10% from baseline (LVEF results must be within the previous 3 months)

Adjuvant Therapy of Locally Advanced or Early Stage Breast Cancer:

4. • Left ventricular ejection fraction (LVEF) is >50% OR LVEF is ≥45% and absolute decrease is <10% from baseline (LVEF results must be within the previous 3 months); AND
   • Use for adjuvant treatment of breast cancer is limited to 14 cycles (42 weeks total)

V. Dosage/Administration 

VI. Billing Code/Availability Information

HCPCS Code:

• J9354 - Injection, ado-trastuzumab emtansine, 1 mg; 1 billable unit = 1 mg

NDC:

• Kadcyla 100 mg single-use vial: 50242-0088-xx 
• Kadcyla 160 mg single-use vial: 50242-0087-xx

VII. References

1. Kadcyla [package insert]. South San Francisco, CA; Genentech, Inc; September 2020. Accessed October 2020.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) ado-trastuzumab emtansine. 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 October 2020.
3. Verma S, Miles D, Gianni L, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012 Nov 8; 367(19):1783-91.
4. von Minckwitz G, Huang CS, Mano MS, et al. Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer. N Engl J Med. 2019 Feb 14;380(7):617-628.
5. Li BT, Shen R, Buonocore D, et al. Ado-trastuzumab emtansine in patients with HER2 mutant lung cancers: Results from a phase II basket trial. J Clin Oncolo 2017, 35: Abstract 8510.
6. 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.

7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Breast Cancer 6.2020. 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 October 2020.
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. 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
10. Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788.
11. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Non-Small Cell Lung Cancer 8.2020. 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 October 2020.
12. Palmetto GBA. Local Coverage Article:  Billing and Coding: Chemotherapy (A56141). Centers for Medicare & Medicaid Services, Inc. Updated on 05/26/2020 with effective date of 04/30/2020. Accessed October 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):