vp-0553
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Phesgo™ (pertuzumab, trastuzumab and hyaluronidase-zzxf) (Subcutaneous)

Policy Number: VP-0553

Last Review Date: 03/01/2022

Date of Origin: 08/04/2020

Dates Reviewed: 08/2020, 09/2020, 01/2021, 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 1

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

  • Neoadjuvant and adjuvant therapy may be authorized for a total of 1 year (up to 18 cycles).

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Phesgo (1,200 mg pertuzumab/600 mg trastuzumab/30,000 units hyaluronidase) single-dose vial: 1 vial as initial dose
  • Phesgo (600 mg pertuzumab/600 mg trastuzumab/20,000 units hyaluronidase) single-dose vial: 1 vial every 21 days
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • Initial Dose: 180 billable units x 1 dose
  • Maintenance Dose: 120 billable units every 21 days

III. Initial Approval Criteria 1-5

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
  • 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 used in combination with pertuzumab, trastuzumab (or trastuzumab biosimilar product [e.g., Ogivri, Kanjinti, Trazimera, Herzuma, Ontruzant]), or trastuzumab and hyaluronidase-oysk (Herceptin Hylecta); AND
  • Therapy will not be substituted for or with pertuzumab or any trastuzumab-based formulation (i.e., trastuzumab [or trastuzumab biosimilar product], ado-trastuzumab emtansine, fam-trastuzumab deruxtecan-nxki, trastuzumab-hyaluronidase, etc.); AND

Breast Cancer † 1-7

  • Used as neoadjuvant therapy; AND
    • Patient has locally advanced, inflammatory, or early stage disease; OR
  • Used as adjuvant therapy; AND
    • Patient has locally advanced, inflammatory, or node positive disease OR early stage disease at high risk of recurrence; OR
  • Used for recurrent unresectable or metastatic disease OR inflammatory breast cancer with no response to preoperative systemic therapy; AND
    • Used as first-line therapy in combination with either paclitaxel or docetaxel; OR
    • Used as subsequent therapy ; AND
            • Patient was previously treated with trastuzumab and chemotherapy; AND
            • Patient has not previously received pertuzumab

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

FDA Approved Indication(s); Compendia recommended Indication(s); Ф Orphan Drug

*HER2-positive overexpression criteria: 6,7

  • 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+

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., interstitial pneumonitis), neutropenia, severe infusion-related reactions (e.g., hypersensitivity reactions, anaphylaxis), etc.; AND
  • Left ventricular ejection fraction (LVEF) within the previous 3 months as follows:
  • Neoadjuvant and adjuvant breast cancer: LVEF is ≥ 50% OR LVEF has had an absolute decrease of < 10% from pre-treatment baseline; OR
  • All other indications: LVEF is > 45% OR LVEF is 40% to 45% and absolute decrease is < 10% from pre-treatment baseline
  • Breast Cancer (neoadjuvant or adjuvant treatment)

  • ​​​​​​Patient has not exceeded a maximum of 1 year of therapy (total of 18 cycles)

V. Dosage/Administration

Indication

Dose

Breast Cancer

Initial Dose

Administer 1,200 mg pertuzumab/600 mg trastuzumab/30,000 units hyaluronidase subcutaneously

Maintenance Dose

Administer 600 mg pertuzumab/600 mg trastuzumab/20,000 units hyaluronidase subcutaneously every 3 weeks

    • Neoadjuvant therapy: administer for 3-6 cycles initially, then continue following surgery to complete 1 year of treatment (up to 18 cycles) or until disease recurrence or unacceptable toxicity
    • Adjuvant therapy: administer for a total of 1 year (up to 18 cycles) or until disease recurrence or unacceptable toxicity
    • Recurrent or metastatic breast cancer: administer until disease progression or until unacceptable toxicity

Note:

  • To be administered by a health care professional for subcutaneous use only in the thigh. Do not administer intravenously.
  • Phesgo has different dosage and administration instructions than intravenous pertuzumab, intravenous trastuzumab, and subcutaneous trastuzumab when administered alone.
  • Refer to the package insert for timing and sequence of dosing with other chemotherapy.
  • Refer to the package insert for transitioning from trastuzumab and/or pertuzumab intravenous.

VI. Billing Code/Availability Information

HCPCS Code:

  • J9316 – Injection, pertuzumab, trastuzumab, and hyaluronidase-zzxf, per 10 mg; 1 billable unit = 10 mg

NDC(s):

  • Phesgo (1,200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase per 15 mL) single-dose vial: 50242-0245-xx
  • Phesgo (600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase per 10 mL) single-dose vial: 50242-0260-xx

VII. References

  1. Phesgo [package insert]. South San Francisco, CA; Genentech, Inc; June 2020. Accessed February 2022.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) pertuzumab, trastuzumab and hyaluronidase-zzxf. 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. 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.
  4. 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.
  5. Tan AR, Im SA, Mattar A, et al. Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive early breast cancer: Primary analysis of the phase III, multicenter, randomized, open-label, two-arm FeDeriCa study [Abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr PD4-07.
  6. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 5/21/20 . Identifier NCT03674112, A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer (PHranceSCa); [Accessed 7/2/20]; Available from: https://clinicaltrials.gov/ct2/show/NCT03674112?term=NCT03674112&draw=2&rank=1.
  7. Gennari A, André F, Barrios CH, et al.; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. Ann Oncol. 2021 Dec;32(12):1475-1495. doi: 10.1016/j.annonc.2021.09.019. Epub 2021 Oct 19. PMID: 34678411.

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): 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