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| Medical Policy: | I-40-009 |
| Topic: | Pertuzumab (Perjeta) |
| Section: | Injections |
| Effective Date: | April 30, 2018 |
| Issue Date: | April 30, 2018 |
| Last Reviewed: | March 2018 |
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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
| Policy Position Coverage is subject to the specific terms of the member’s benefit plan. |
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.
Note: Dosage recommendations per the FDA label.
* Note: Language derived from NCCN guidelines.
See medical policy bulletin I-21 for information on Trastuzumab (Herceptin). |
| Place of Service: Outpatient |
Experimental/Investigational (E/I) services are not covered regardless of place of service.
The administration of pertuzumab (Perjeta) for treatment of malignancies is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
| The policy position applies to all commercial lines of business |
| Denial Statements |
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
| Links |
- Link to Provider Resource Center for the Medical Policy Update
06/2017, Criteria Revised for Pertuzumab for Treatment of Malignancies
05/2017, Revised Guidelines for Pertuzumab (Perjeta)
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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
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If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
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