vp-0092
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Kadcyla® (ado-trastuzumab emtansine) (Intravenous)

Policy Number: VP-0092

Last Review Date: 06/06/2022

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, 03/2021, 06/2021, 09/2021, 12/2021, 03/2022, 06/2022

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

I. Length of Authorization 1

Coverage will be provided for 6 months and may be renewed (unless otherwise specified).

  • Adjuvant treatment in breast cancer is limited to 14 cycles (42 weeks total).

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Kadcyla 100 mg single-dose vial: 1 vial every 21 days 
  • Kadcyla 160 mg single-dose vial: 3 vials every 21 days
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 480 billable units every 21 days

III. Initial Approval Criteria 1

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND

Universal Criteria 1

  • 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
  • Used as a single agent; 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 † ‡ 1-4,7

  • Patient has human epidermal growth factor receptor 2 (HER2)-positive* disease as determined by an FDA-approved or CLIA-compliant testv; AND
    • Used as adjuvant therapy; AND
      • Patient has locally advanced residual or node positive disease following completion of planned chemotherapy and mastectomy or breast-conserving surgery (BCS) ; OR
      • Patient has inflammatory disease with a response to preoperative systemic therapy, followed by surgery, and need to complete planned chemotherapy ; OR
      • Patient has inflammatory residual disease following preoperative therapy ; OR
      • Patient has early breast cancer with residual invasive disease after neoadjuvant taxane and trastuzumab-based therapy ; OR
    • Patient has metastatic or recurrent unresectable disease OR inflammatory breast cancer with no response to preoperative systemic therapy; AND
      • Used as second-line therapy and beyond; OR
    • Patient has disease recurrence during or within 6 months of completing adjuvant therapy ; AND
      • Patient previously received trastuzumab and a taxane, separately or in combination

Central Nervous System (CNS) Cancer ‡ 2,13

  • Patient has human epidermal growth factor receptor 2 (HER2)-positive* disease as determined by an FDA-approved or CLIA-compliant testv; AND
  • Used for the treatment of brain metastases in patients with breast cancer; AND
    • Used as initial treatment in patients with small asymptomatic brain metastases; OR
    • Used for relapsed limited brain metastases with either stable systemic disease or reasonable treatment options; OR
    • Patient has recurrent limited brain metastases; OR
    • Used for recurrent extensive brain metastases with stable systemic disease or reasonable systemic treatment options

Non-Small Cell Lung Cancer (NSCLC) ‡ 2,5,11

  • Patient has ERBB2 (HER2) mutation positive disease as determined by an FDA-approved or CLIA-complaint testv; AND
  • Patient has metastatic disease

Head and Neck Cancer ‡ 2,12

  • Patient has human epidermal growth factor receptor 2 (HER2)-positive* disease as determined by an FDA-approved or CLIA-compliant testv; AND
  • Patient has salivary gland tumors; AND
  • Used for one of the following:
    • Recurrent disease with distant metastases
    • Unresectable locoregional recurrence with prior radiation therapy (RT)
    • Unresectable second primary with prior RT

*HER2-positive overexpression criteria

Breast, CNS, and Head and Neck Cancer: 7,8

  • Immunohistochemistry (IHC) assay 3+; OR
  • Dual-probe in situ hybridization (ISH) assay HER2/CEP17 ratio ≥ 2.0 AND average HER2 copy number ≥ 4.0 signals/cell; OR
  • Dual-probe in situ hybridization (ISH) assay AND concurrent IHC indicating one of the following:
          • HER2/CEP17 ratio ≥ 2.0 AND average HER2 copy number < 4.0 signals/cell AND concurrent IHC 3+; OR
          • HER2/CEP17 ratio < 2.0 AND average HER2 copy number ≥ 6.0 signals/cell AND concurrent IHC 2+ or 3+; OR
    • HER2/CEP17 ratio < 2.0 AND average HER2 copy number ≥ 4.0 and < 6.0 signals/cell AND concurrent IHC 3+

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

FDA approved indication(s);Compendia Recommended Indication(s); Ф Orphan Drug

IV. Renewal Criteria 1,5

Coverage may be renewed based upon the following criteria:

  • Patient continues to meet the 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: hepatotoxicity, pulmonary toxicity (i.e., interstitial lung disease, pneumonitis), thrombocytopenia, neurotoxicity, infusion-related and hypersensitivity reactions, hemorrhage, extravasation at infusion site, etc.; AND
  • Left ventricular ejection fraction (LVEF) obtained within the previous 3 months as follows:
    • Metastatic or Recurrent Breast Cancer: LVEF is >45% OR LVEF is 40% to ≤45% and absolute decrease is <10% from baseline; OR
    • All other indications: LVEF is ≥50% OR LVEF is 45% to <50% and absolute decrease is <10% from baseline; AND

Breast Cancer (adjuvant treatment)

  • Patient has not exceeded a maximum of 14 cycles of therapy (42 weeks total)

V. Dosage/Administration 1,5,12,13

Indication

Dose

Breast Cancer (adjuvant treatment)

Administer 3.6 mg/kg given as an intravenous infusion every 3 weeks (21-day cycle) for up to 14 cycles unless there is disease recurrence or unmanageable toxicity

Breast Cancer (all other treatment settings), CNS Cancer, NSCLC, Head and Neck Cancer

Administer 3.6 mg/kg given as an intravenous infusion every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity

VI. Billing Code/Availability Information

HCPCS Code:

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

NDC(s):

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

VII. References

  1. Kadcyla [package insert]. South San Francisco, CA; Genentech, Inc; February 2022. Accessed April 2022.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) ado-trastuzumab emtansine. National Comprehensive Cancer Network, 2022. 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 April 2022.
  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.
  1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer, Version 3.2022. National Comprehensive Cancer Network, 2022. 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 May 2022.
  2. 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.
  3. 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
  4. Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788.
  5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer, Version 3.2022. National Comprehensive Cancer Network, 2022. 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 April 2022.
  6. Jhaveri KL, Wang XV, Luoh SW, et al. Ado-trastuzumab emtansine (T-DM1) in patients with HER2-amplified tumors excluding breast and gastric/gastroesophageal junction (GEJ) adenocarcinomas: results from the NCI-MATCH trial (EAY131) subprotocol Q. Ann Oncol. 2019 Nov 1;30(11):1821-1830.
  7. Montemurro F, Delaloge S, Barrios CH, et al. Trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer and brain metastases: exploratory final analysis of cohort 1 from KAMILLA, a single-arm phase IIIb clinical trial. Ann Oncol. 2020 Oct;31(10):1350-1358. doi: 10.1016/j.annonc.2020.06.020.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C06.9

Malignant neoplasm of mouth, unspecified

C07

Malignant neoplasm of parotid gland

C08.0

Malignant neoplasm of submandibular gland

C08.1

Malignant neoplasm of sublingual gland

C08.9

Malignant neoplasm of major salivary gland, unspecified

C33

Malignant neoplasm of trachea

C34.00

Malignant neoplasm of unspecified main bronchus

C34.01

Malignant neoplasm of right main bronchus

C34.02

Malignant neoplasm of left main bronchus

C34.10

Malignant neoplasm of upper lobe, unspecified bronchus or lung

C34.11

Malignant neoplasm of upper lobe, right bronchus or lung

C34.12

Malignant neoplasm of upper lobe, left bronchus or lung

C34.2

Malignant neoplasm of middle lobe, bronchus or lung

C34.30

Malignant neoplasm of lower lobe, unspecified bronchus or lung

C34.31

Malignant neoplasm of lower lobe, right bronchus or lung

C34.32

Malignant neoplasm of lower lobe, left bronchus or lung

C34.80

Malignant neoplasm of overlapping sites of unspecified bronchus and lung

C34.81

Malignant neoplasm of overlapping sites of right bronchus and lung

C34.82

Malignant neoplasm of overlapping sites of left bronchus and lung

C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

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

C79.31

Secondary malignant neoplasm of brain

Z85.118

Personal history of other malignant neoplasm of bronchus and lung

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 Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/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): 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