vp-0449
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Herceptin Hylecta™ (trastuzumab and hyaluronidase-oysk) (Subcutaneous)

Policy Number: VP-0449

Last Review Date: 03/01/2022

Date of Origin: 04/03/2019

Dates Reviewed: 04/2019, 06/2019, 09/2019, 12/2019, 03/2020, 06/2020, 09/2020, 03/2021, 03/2022

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

Coverage is provided for 6 months and may be renewed.

  • Adjuvant therapy may be authorized for a total of fifty-two (52) weeks.

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Herceptin Hylecta (600 mg trastuzumab/10,000 units hyaluronidase) single-dose vial: 1 vial every 21 days
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 60 billable units every 21 days

III. Initial Approval Criteria 1-5

Coverage is provided in the following conditions:

  • Trazimera (trastuzumab-qyyp) and Kanjinti (trastuzumab-anns) are the preferred products. Patient must have tried and had an inadequate response or intolerance to, or a contraindication to Trazimera and Kanjinti, attributable to the biosimilar formulation, prior to consideration of a non-preferred trastuzumab product including Herceptin Hylecta (trastuzumab/hyaluronidase-oysk) OR Patient is continuing treatment with a non-preferred trastuzumab product including Herceptin Hylecta; AND

  • Patient is 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
  • Therapy will not be substituted with or for ado-trastuzumab emtansine (Kadcyla) or fam-trastuzumab deruxtecan-nxki (Enhertu); AND
  • Therapy will not be used in combination with intravenous chemotherapy agents; AND
  • Therapy will not be used in combination with trastuzumab (or any of its biosimilar products [e.g., Ogivri, Kanjinti, Trazimera, Herzuma, Ontruzant]) or pertuzumab/trastuzumab and hyaluronidase-zzxf (Phesgo); AND

Breast Cancer**

  • Used as adjuvant therapy; AND
    • Used as a single agent following anthracycline-based therapy ; OR
  • Used for metastatic disease; AND
    • Used as a single agent in patients who have received one or more prior chemotherapy regimens for metastatic disease

**NOTE: Coverage for Herceptin Hylecta will NOT encompass all FDA approved indications. Coverage will be ONLY provided when the above criteria is met.

FDA approved indications:

Adjuvant treatment of adults with HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer:

  • as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
  • as part of a treatment regimen with docetaxel and carboplatin
  • as a single agent following multi-modality anthracycline based therapy

Metastatic treatment of adults:

  • In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer
  • As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease

*HER2-positive overexpression criteria: 6,7

  • Immunohistochemistry (IHC) assay 3+; OR
  • Dual-probe in situ hybridization (ISH) assay HER2/CEP17 ratio2.0 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

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: cardiotoxicity (e.g., left ventricular dysfunction, cardiomyopathy), pulmonary toxicity (e.g., dyspnea, interstitial pneumonitis), neutropenia, severe administration-related reactions (e.g., hypersensitivity, anaphylaxis), etc.; AND
  • Left ventricular ejection fraction (LVEF) within the previous 3 months as follows:
    • LVEF is within the institutional normal limits, and has not had an absolute decrease of  ≥ 16% from pre-treatment baseline; OR
    • LVEF is below the institutional lower limits of normal, and has not had an absolute decrease of  ≥ 10% from pre-treatment baseline; AND

Breast Cancer (adjuvant treatment)

  • Patient has not exceeded a maximum of fifty-two (52) weeks of therapy

V. Dosage/Administration 1

Indication

Dose

Breast Cancer

Administer 600 mg trastuzumab and 10,000 units hyaluronidase subcutaneously every three weeks

    • Adjuvant therapy: administer for 52 weeks or until disease recurrence
    • Metastatic breast cancer: administer until disease progression

Note:

  • To be administered by a health care professional for subcutaneous use only in the thigh. Do not administer intravenously.

VI. Billing Code/Availability Information

HCPCS Code:

  • J9356 – Injection, trastuzumab, 10 mg and hyaluronidase-oysk: 1 billable unit = 10 mg

NDC:

  • Herceptin  Hylecta 600 mg/10,000 units (providing 600 mg trastuzumab and 10,000 units hyaluronidase per 5 mL) single-dose vials: 50242-0077-xx

VII. References

  1. Herceptin Hylecta [package insert]. South San Francisco, CA; Genentech, Inc; February 2019. Accessed February 2022.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) trastuzumab and hyaluronidase human. 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 February 2022.
  3. Jackisch C, Stroyakovskiy D, Pivot X, et al. Subcutaneous vs Intravenous Trastuzumab for Patients With ERBB2-Positive Early Breast Cancer: Final Analysis of the HannaH Phase 3 Randomized Clinical Trial. JAMA Oncol. 2019 May 1;5(5):e190339.
  4. Gligorov J, Ataseven B, Verrill M, et al. Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients. Eur J Cancer. 2017 Sep;82:237-246.
  5. Pivot X, Verma S, Fallowfield L, et al. Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: Final analysis of the randomised, two-cohort PrefHer study. Eur J Cancer. 2017 Nov;86:82-90.
  6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer 2.2022. 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 February 2022.
  7. 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.
  8. First Coast Service Options, Inc. Local Coverage Article: Billing and Coding: Trastuzumab – Trastuzumab Biologics (A56660). Centers for Medicare & Medicaid Services, Inc. Updated on 10/08/2021 with effective date of 10/01/2021. Accessed February 2022.

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 female breast

C50.022

Malignant neoplasm of nipple and areola, left female breast

C50.029

Malignant neoplasm of nipple and areola, unspecified female 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

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):

Jurisdiction(s): N (9)

NCD/LCD/LCA Document(s): A56660

https://www.cms.gov/medicare-coverage-database/new-search/search-results.aspx?keyword=a56660&areaId=all&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP

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