Pertuzumab (Perjeta®)
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. Metastatic breast cancer
In combination with trastuzumab and docetaxel for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
2. Neoadjuvant treatment of breast cancer
In combination with trastuzumab and chemotherapy as neoadjuvant treatment of patients 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.
3. Adjuvant treatment of breast cancer
In combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.
B. Compendial Uses
1. Treatment of recurrent or stage IV (M1) human epidermal growth factor receptor 2 (HER2)-positive breast cancer
2. Adjuvant treatment of locally advanced HER2-positive breast cancer
3. HER2-amplified and RAS and BRAF wild-type colorectal cancer (including appendiceal adenocarcinoma and anal adenocarcinoma) in combination with trastuzumab
4. HER2-positive recurrent salivary gland tumors
5. HER2-positive hepatobiliary cancers
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review: human epidermal growth factor receptor 2 (HER2) status, RAS mutation status (where applicable), BRAF mutation status (where applicable)
III. CRITERIA FOR INITIAL APPROVAL
A. Breast Cancer
1. Authorization of 12 months may be granted for pre-operative (neoadjuvant) therapy of HER2-positive breast cancer in combination with trastuzumab and chemotherapy for locally advanced, inflammatory or early stage breast cancer (either greater than 2 cm in diameter or node positive).
2. Authorization of 12 months may be granted for adjuvant therapy of HER2-positive breast cancer that is either node-positive or at high risk for recurrence in combination with trastuzumab and chemotherapy.
3. Authorizations of 12 months may be granted for the treatment of recurrent or metastatic HER2-positive breast cancer or HER2-positive breast cancer with no response to preoperative systemic therapy in combination with trastuzumab.
B. Colorectal Cancer
Authorization of 12 months may be granted for treatment of colorectal cancer, including appendiceal adenocarcinoma and anal adenocarcinoma, with HER2-amplified and RAS and BRAF wild-type disease not previously treated with HER2 inhibitor in combination with trastuzumab when either of the following are met:
1. Member is not appropriate for intensive therapy
2. Perjeta will be used as subsequent therapy for progression of advanced or metastatic disease
C. Salivary Gland Tumor
Authorization of 12 months may be granted for treatment of recurrent HER2-positive salivary gland tumors in combination with trastuzumab.
D. Hepatobiliary Cancers
Authorization of 12 months may be granted for subsequent treatment of unresectable or metastatic HER2-positive hepatobiliary cancers (including intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancer) when used in combination with trastuzumab.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section III when there is no evidence of unacceptable toxicity or disease progression while on the current regimen. Adjuvant and neoadjuvant treatment of breast cancer will be approved for a total of 12 months of therapy.
MEDICATION QUANTITY LIMITS
Drug Name |
Diagnosis |
Maximum Dosing Regimen |
Perjeta (Pertuzumab) |
Breast Cancer |
Route of Administration: Intravenous Initial: 840mg once Maintenance: 420mg every 3 weeks |
Perjeta (Pertuzumab) |
Colorectal Cancer or Appendiceal Adenocarcinoma |
Route of Administration: Intravenous Initial: 840mg once Maintenance: 420mg every 3 weeks |
Perjeta (Pertuzumab) |
Hepatobiliary Cancer |
Route of Administration: Intravenous Initial: 840mg once Maintenance: 420mg every 3 weeks |
Perjeta (Pertuzumab) |
Salivary Gland Tumors |
Route of Administration: Intravenous Initial: 840mg once Maintenance: 420mg every 3 weeks |
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
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).
REFERENCES
1. Perjeta [package insert]. South San Francisco, CA: Genentech, Inc.; February 2021.
2. The NCCN Drugs & Biologics Compendium® © 2022 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed December 9, 2022.
3. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 4.2022. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed December 9, 2022.
4. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Anal Carcinoma. Version 2.2022. https://www.nccn.org/professionals/physician_gls/pdf/anal.pdf Accessed December 9, 2022.
ORIGINAL EFFECTIVE DATE: 7/5/2012
MOST RECENT REVIEW DATE: 4/1/2024
ID_CHS
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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