Pertuzumab (Perjeta)

Section: Injections
Effective Date: June 01, 2020
Revised Date: May 07, 2020
Last Reviewed: May 19, 2020

Description

Pertuzumab (Perjeta®) is a monoclonal antibody that is a human epidermal growth factor receptor 2 (HER2) antagonist. By binding to the HER2 protein, pertuzumab (Perjeta) inhibits the growth of tumor cells and mediates antibody-dependent cellular cytotoxicity in cancer cells that overexpress the HER2 protein.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Pertuzumab (Perjeta) may be considered medically necessary for ANY of the following:

Food and Drug Administration (FDA) Indications:

Breast Cancer

  • In combination with trastuzumab and docetaxel for the treatment of individuals with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease; or
  • In combination with trastuzumab and chemotherapy as neoadjuvant treatment of individuals with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer; or
  • In combination with trastuzumab and chemotherapy as adjuvant treatment of individuals with HER2-positive early breast cancer at high risk of reoccurrence; or

National Comprehensive Cancer Network (NCCN) Recommendations:

Breast Cancer

  • Preoperative systemic therapy for individuals with HER2-positive tumors and locally advanced clinical stage T2 or greater and M0, or N1 or greater and M0 disease in ANY of the following:
    • In combination with trastuzumab and paclitaxel following AC (doxorubicin and cyclophosphamide) regimen; or
    • As a component of TCHP (docetaxel, carboplatin, trastuzumab, and pertuzumab) regimen; or
    • In combination with trastuzumab and docetaxel following AC regimen; or
  • Adjuvant systemic therapy for clinical stage T1-3, N1, M0 individuals with node positive HER2-positive tumors:
    • In combination with trastuzumab and paclitaxel following AC regimen; or
    • As a component of TCHP regimen; or
    • In combination with trastuzumab and docetaxel following AC regimen; or
  • As adjuvant systemic therapy for individuals with HER2-positive tumors and locally advanced clinical stage T2 or greater and M0, or N1 or greater and M0 disease following completion of planned chemotherapy and following mastectomy or lumpectomy with surgical axillary staging, with trastuzumab in ANY of the following:
    • ypT0N0 or pCR (pathological complete response); or
    • ypT1-4N0 or residual disease (if ado-trastuzumab discontinued for toxicity); or
    • ypN1 or greater, or node positive (if ado-trastuzumab discontinued for toxicity); or
  • Used for recurrent or metastatic stage IV HER2-positive disease that is either hormone receptor-negative or hormone receptor-positive in ANY of the following:
    • As first-line therapy in combination with trastuzumab with docetaxel or paclitaxel; or
    • In combination with trastuzumab with or without cytotoxic therapy (eg, vinorelbine or taxane) for one line of therapy beyond first-line therapy in individuals previously treated with chemotherapy and trastuzumab in the absence of pertuzumab (Perjeta); or

Colon Cancer

  • As therapy in combination with trastuzumab in HER2-amplified and RAS wild-type individuals who are not appropriate for intensive therapy, if no previous treatment with a HER2 inhibitor in ANY of the following:
    • Primary treatment for locally unresectable or medically inoperable disease; or
    • Unresectable synchronous liver and/or lung metastases that remain unresectable after primary systemic therapy; or
    • Primary treatment for synchronous abdominal/peritoneal metastases that are non-obstructing, or following local therapy for those with existing or imminent obstruction; or
    • Synchronous unresectable metastases of other sites; or
    • Primary treatment for unresectable metachronous metastases in individuals in ANY of the following:
      • Who have not received previous adjuvant leucovorin, fluorouracil, and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CapeOX) within the past 12 months; or
      • Who have received fluorouracil/leucovorin (5-FU/LV) or capecitabine therapy; or
      • Who have not received any previous chemotherapy; or
    • Unresectable metachronous metastases that remain unresectable after primary treatment; or
  • As adjuvant therapy in combination with trastuzumab in HER2-amplied and RAS wild-type individuals who are not appropriate for intensive therapy in ANY of the following:
    • Following synchronized or staged resection for synchronous liver and/or lung metastases that converted from unresectable to resectable disease after primary treatment; or
    • Following resection and/or local therapy for resectable metachronous metastases in those who have received previous chemotherapy; or
    • For unresectable metachronous metastases that converted to resectable disease after primary treatment; or
  • As subsequent therapy in combination with trastuzumab for progression of advanced or metastatic disease in HER2-amplified and RAS wild-type individuals not previously treated with a HER2 inhibitor, previously treated with ANY of the following:
    • Oxaliplatin-based therapy without irinotecan; or
    • Irinotecan-based therapy without oxaliplatin; or
    • Oxaliplatin or irinotecan; or
    • A fluoropyrimidine without irinotecan or oxaliplatin; or

Rectal Cancer

  • As therapy in combination with trastuzumab in HER2-amplified and RAS wild-type individuals who are not appropriate for intensive therapy, if no previous treatment with a HER2 inhibitor in ANY of the following:
    • Synchronous liver only and/or lung only metastases that are unresectable or medically inoperable and remain unresectable with no progression of primary tumor after primary systemic therapy; or
    • Following palliative radiation therapy (RT) or chemo/RT for synchronous liver only and/or lung only metastases that are unresectable or medically inoperable and remain unresectable with progression of primary tumor after primary systemic therapy; or
    • As primary treatment for synchronous abdominal/peritoneal metastases that are non-obstructing, or following local therapy for those with existing or imminent obstruction; or
    • As primary treatment for synchronous unresectable metastases of other sites; or
    • As primary treatment for unresectable metachronous metastases in individuals in ANY of the following:
      • Who have not received previous adjuvant FOLFOX or CapeOX within the past 12 months; or
      • Who have received previous 5-FU/LV or capecitabine therapy; or
      • Who have not received any previous chemotherapy; or
  • As adjuvant therapy in combination with trastuzumab in HER2-amplified and RAS wild-type who are not appropriate for intensive therapy in ANY of the following:
    • As treatment following resection and/or local therapy for resectable metachronous metastases in those who have received previous chemotherapy; or
    • As treatment for unresectable metachronous metastases that converted to resectable disease after primary treatment; or
  • As subsequent therapy in combination with trastuzumab for progression of advanced or metastatic disease in HER2-amplified and RAS wild-type individuals not previously treated with a HER2 inhibitor, previously treated with ANY of the following:
    • Oxaliplatin-based therapy without irinotecan; or
    • Irinotecan-based therapy without oxaliplatin; or
    • Oxaliplatin or irinotecan; or
    • A fluoropyrimidine without irinotecan or oxaliplatin.

The use of pertuzumab (Perjeta) is considered experimental/investigational and therefore non-covered for any other indications. Scientific evidence does not support the use for all other indications.

Procedure Codes

J9306

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

If no residual disease after preoperative therapy or not preoperative therapy, complete up to one year of HER2 targeted therapy with trastuzumab with or without pertuzumab after completing planned chemotherapy regimen course. If residual disease is present after preoperative therapy and ado-trastuzumab emtansine is discontinued for toxicity, then trastuzumab with or without pertuzumab to complete one year of therapy can be used.


Diagnosis Codes

C17.0

C17.1

C17.2

C17.8

C17.9

C18.0

C18.1

C18.2

C18.3

C18.4

C18.5

C18.6

C18.7

C18.8

C18.9

C19

C20

C21.8

C50.011

C50.012

C50.019

C50.021

C50.022

C50.029

C50.111

C50.112

C50.119

C50.121

C50.122

C50.129

C50.211

C50.212

C50.219

C50.221

C50.222

C50.229

C50.311

C50.312

C50.319

C50.321

C50.322

C50.329

C50.411

C50.412

C50.419

C50.421

C50.422

C50.429

C50.511

C50.512

C50.519

C50.521

C50.522

C50.529

C50.611

C50.612

C50.619

C50.621

C50.622

C50.629

C50.811

C50.812

C50.819

C50.821

C50.822

C50.829

C50.911

C50.912

C50.919

C50.921

C50.922

C50.929

C78.00

C78.01

C78.02

C78.6

C78.7

Z85.038

Z85.068

Z85.3

 

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Original Effective Date July 1, 2018

Internal Medical Policy Committee 11-14-2019 added diagnosis codes to policy.

Internal Medical Policy Committee 5-19-2020 added additional NCCN recommendations, added additional diagnosis

Links

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.