Pertuzumab (Perjeta)

Section: Injections
Effective Date: July 01, 2018
Revised Date: November 26, 2019

Description

Pertuzumab (Perjeta®) is a monoclonal antibody that is a human epidermal growth factor receptor 2 (HER2) antagonists.

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 the treatment of breast cancer for ANY ONE of the following indications:

FDA Approved Indications:

  • In combination with trastuzumab and docetaxel for the first-line 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 (Herceptin) 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 (Herceptin) and chemotherapy as adjuvant treatment of individuals with HER2-positive early breast cancer at high risk of reoccurrence; or

NCCN Approved Indications:

  • Preoperative systemic therapy for individuals with HER2-positive stage IIA (T0, N1, M0 or T1, N1, M0 or T2, N0, M0), stage IIB (T2, N1, M0 or T3, N0, M0), or stage IIIA (T3, N1, M0) disease who desire breast preservation and fulfill criteria for breast-conserving surgery except for tumor size or for those who have node-positive disease likely to become node-negative with preoperative systemic therapy, or for locally advanced disease (stage IIIA (any T, N2, M0), IIIB, or IIIC):
    • In combination with trastuzumab and paclitaxel (preferred regimen*) or trastuzumab and docetaxel following AC (doxorubicin and cyclophosphamide) regimen; or
    • In combination with TCH (docetaxel, carboplatin, and trastuzumab) regimen (preferred regimen*); or
  • Adjuvant systemic therapy for individuals with HER2-positive disease:
    • In combination with trastuzumab and paclitaxel (preferred regimen*) or trastuzumab and docetaxel following AC (doxorubicin and cyclophosphamide) regimen; or
    • In combination with TCH (docetaxel, carboplatin, and trastuzumab) regimen (preferred regimen*); or
  • Used for recurrent or metastatic HER2-positive disease that is either hormone receptor-negative, hormone receptor-positive and endocrine therapy refractory, for symptomatic visceral disease, or visceral crisis:
    • As preferred first-line therapy in combination with trastuzumab with docetaxel or paclitaxel; or
    • May be considered in combination with trastuzumab with or without cytotoxic therapy (eg, vinorelbine or taxane) for one line of therapy beyond first-line therapy in patients previously treated with chemotherapy and trastuzumab in the absence of pertuzumab (Perjeta).

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.

* Note: Language derived from NCCN guidelines.

Diagnosis Codes

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 C79.81

Links