BlueCross BlueShield of Tennessee Medical Policy Manual

Pertuzumab (Perjeta®)

NDC CODE(S)

50242-0145-XX PERJETA 420MG/14ML Solution (GENENTECH)

DESCRIPTION

Pertuzumab is a recombinant monoclonal antibody.  It is an antineoplastic agent that targets the human epidermal growth factor receptor 2 protein known as HER2.  It blocks two major intracellular signaling pathways, mitogen-activated protein (MAP) kinase and phosphoinositide 3-kinase (PI3K).  This results in cell growth arrest and apoptosis (cell destruction), inhibiting the proliferation of human tumor cells.  By combining pertuzumab with trastuzumab, tumor inhibition was significantly increased.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL CRITERIA

Universal Criteria

Breast Cancer

Colorectal Cancer

*HER2-positive overexpression criteria of ANY ONE of the following:

·         Immunohistochemistry (IHC) assay 3+

·         Dual-probe in situ hybridization (ISH) assay HER2/CEP17 ratio ≥ 2.0 AND average HER2  copy number ≥ 4.0 signals/cell

·          Dual-probe in situ hybridization (ISH) assay AND concurrent IHC indicating ANY ONE of the following:

  • HER2/CEP17 ratio ≥ 2.0 AND average HER2 copy number < 4.0 signals/cell AND concurrent IHC 3+

  • HER2/CEP17 ratio < 2.0 AND average HER2 copy number ≥ 6.0 signals/cell AND concurrent IHC 2+ or 3+

  • HER2/CEP17 ratio < 2.0 AND average HER2 copy number ≥ 4.0 and < 6.0 signals/cell AND concurrent IHC 3+

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

RENEWAL CRITERIA

DOSAGE/ADMINISTRATION

INDICATION

DOSE

Breast Cancer

Administer 840 mg intravenously x 1 dose, then 420 mg intravenously every 21 days

thereafter until disease progression or unmanageable toxicity

·         Neoadjuvant therapy consists of 3 to 6 cycles prior to surgery

·         Use for neoadjuvant and adjuvant early breast cancer treatment is limited to a total of 1 year of treatment (total of 18 cycles)

*Note: When used for metastatic breast cancer, therapy may be continued until disease progression or unmanageable toxicity.

Colorectal Cancer

Administer 840 mg intravenously x 1 dose, then 420 mg intravenously every 21 days

thereafter until disease progression or unmanageable toxicity

LENGTH OF AUTHORIZATION

DOSAGE LIMITS

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

 

Loading Dose

Maintenance Dose

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

SOURCES

1.     Perjeta [package insert]. South San Francisco, CA; Genentech, Inc.; January 2020. Accessed October 2020.

2.     Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) pertuzumab. 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.     Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer 56.2020. 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.

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.     Gianni L, Pienkowski T, Im YH, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012 Jan;13(1):25-32.

6.     Baselga J, Cortes J, Kim SB, et al. CLEOPATRA Study Group. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012;366:109-119.

7.     Schneeweiss A., Chia S., Hickish T., et al. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol 2013; 24 (9): 2278-2284.

8.     von Minckwitz G, Procter M, de Azambuja E, et al. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017;377(2):122-131.

9.     Hainsworth JD, Meric-Bernstam F, Swanton C, et al. Targeted Therapy for Advanced Solid Tumors on the Basis of Molecular Profiles: Results From MyPathway, an Open-Label, Phase IIa Multiple Basket Study. Clin Oncol. 2018 Feb 20;36(6):536-542.

10.  Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer 4.2020. 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.

11.  Lexi-Comp Online. (2021). AHFS DI. Pertuzumab. Retrieved January 21, 2021 from Lexi-Comp Online with AHFS.

12.  MICROMEDEX Healthcare Series. Drugdex Evaluations. (2021, January). Pertuzumab. Retrieved January 21, 2021 from MICROMEDEX Healthcare Series.

ORIGINAL EFFECTIVE DATE:  7/5/2012

MOST RECENT REVIEW DATE:   6/2/2021

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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