Clinical Policy: Pertuzumab (Perjeta) Reference Number: ERX.SPMN.94

Transcription

1 Clinical Policy: (Perjeta) Reference Number: ERX.SPMN.94 Effective Date: 07/16 Last Review Date: 06/16 Coding Implications Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Policy/Criteria It is the policy of health plans affiliated with Envolve Pharmacy Solutions that pertuzumab (Perjeta ) is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Metastatic/Recurrent Breast Cancer (must meet all): 1. Diagnosis of HER2-positive recurrent and/ metastatic breast cancer; 2. Member meets a or b: a. FDA approved use: i. Perjeta will be used in combination with trastuzumab and docetaxel; ii. Member has not received prior anti-her2 therapy or chemotherapy for their metastatic disease b. NCCN recommended use: i. Disease is positive for one the following characteristics: 1. Hormone receptor-negative; 2. Hormone receptor-positive and endocrine therapy refractory; 3. Concomitant symptomatic visceral disease or visceral crisis; ii. Perjeta will be used in one of the following ways: 1. As preferred first-line therapy in combination with trastuzumab with docetaxel or paclitaxel; 2. In combination with trastuzumab with or without cytotoxic therapy (e.g., 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. Approval duration: 3 months B. Nonmetastatic Breast Cancer (must meet all): 1. Diagnosis of nonmetastatic HER2-positive breast cancer 2. Member meets a or b a. FDA approved use: i. The disease is locally advanced, inflammatory, or early stage (either greater than 2 cm in diameter or node positive); ii. Perjeta will be used in combination with trastuzumab and docetaxel for neoadjuvant treatment (to shrink a tumor before main treatment) and as part of a complete treatment regimen for early breast cancer in a pre/post or pre-operative setting; Page 1 of 5

2 b. NCCN recommended uses (i or ii) i. Perjeta will be used for preoperative systemic therapy in one of the following ways: 1. In combination with trastuzumab and paclitaxel (preferred regimen) or trastuzumab and docetaxel following AC (doxorubicin and cyclophosphamide) regimen; 2. In combination with TCH (docetaxel, carboplatin, and trastuzumab) regimen (preferred regimen); 3. In combination with trastuzumab and paclitaxel or trastuzumab and docetaxel prior to or following FEC/CEF (fluorouracil, epirubicin, and cyclophosphamide) regimen; ii. -containing regimen was not used as neoadjuvant therapy and perjeta will be used as adjuvant systemic in one of the following ways: 1. In combination with trastuzumab and paclitaxel (preferred regimen) or trastuzumab and docetaxel following AC (doxorubicin and cyclophosphamide) regimen; 2. In combination with TCH (docetaxel, carboplatin, and trastuzumab) regimen; 3. In combination with trastuzumab and paclitaxel or trastuzumab and docetaxel prior to or following FEC/CEF (fluorouracil, epirubicin, and cyclophosphamide) regimen. C. Other diagnoses/indications: Refer to ERX.SPMN.16 - Global Biopharm Policy. Approval duration: 3 months II. Continued Approval A. Metastatic, Recurrent & Nonmetastatic Breast Cancer (must meet all): 1. Currently receiving medication via health plan benefit or member has previously met all initial approval criteria. Approval duration: 6 months (Up to 6 total cycles if breast cancer is not metastatic) B. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via health plan benefit and documentation supports positive response to therapy; or 2. Refer to ERX.SPMN.16 - Global Biopharm Policy. Page 2 of 5

3 Background Description/Mechanism of Action: is a recombinant humanized monoclonal antibody produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture containing the antibiotic, gentamicin. Gentamicin is not detectable in the final product. targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2) and, thereby, blocks ligand-dependent heterodimerization of HER2 with other HER family members, including EGFR, HER3, and HER4. As a result, pertuzumab inhibits ligand-initiated intracellular signaling through two major signal pathways, mitogen-activated protein (MAP) kinase, and phosphoinositide 3- kinase (PI3K). Inhibition of these signaling pathways can result in cell growth arrest and apoptosis, respectively. In addition, pertuzumab mediates antibody-dependent cellmediated cytotoxicity (ADCC). While pertuzumab alone inhibited the proliferation of human tumor cells, the combination of pertuzumab and trastuzumab augmented antitumor activity in HER2-overexpressing xenograft models. Formulations: Perjeta is a sterile, clear to slightly opalescent, colorless to pale brown liquid for intravenous infusion. Each single use vial contains 420 mg of pertuzumab at a concentration of 30 mg/ml in 20 mm L-histidine acetate (ph 6.0), 120 mm sucrose and 0.02% polysorbate 20. FDA Approved Indications: Perjeta (pertuzumab) is a HER2/neu receptor antagonist/formulation for intravenous infusion with the following indications: Metastatic breast cancer o Perjeta is indicated for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-her2 therapy or chemotherapy for metastatic disease. Neoadjuvant treatment of breast cancer o Perjeta is indicated for use in combination with trastuzumab and docetaxel for the 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. This indication is based on demonstration of an improvement in pathological complete response rate. No data are available demonstrating improvement in event-free survival or overall survival. Limitations of use: o The safety of Perjeta as part of a doxorubicin-containing regimen has not been established. o The safety of Perjeta administered for greater than 6 cycles for early breast cancer has not been established. o Page 3 of 5

4 Appendices Appendix A: Abbreviation Key HER2: human epidermal growth factor receptor 2 protein Coding Implications Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services. HCPCS Codes Description Reviews, Revisions, and Approvals Date Approval Date Policy created. 05/16 06/16 References 1. Perjeta Prescribing Information. South San Francisco, CA: Genentech, Inc.; March Available at Accessed May 4, In: National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at NCCN.org. Accessed May 4, Neoadjuvant therapy: NCI dictionary of cancer terms. National Cancer Institute at the National Institutes of Health. Available at Accessed May 4, Page 4 of 5

5 Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it constitute a contract or guarantee regarding payment or results. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This policy is the property of Envolve Pharmacy Solutions. Unauthorized copying, use, and distribution of this Policy or any information contained herein is strictly prohibited. By accessing this policy, you agree to be bound by the foregoing terms and conditions, in addition to the Site Use Agreement for Health Plans associated with Envolve Pharmacy Solutions Envolve Pharmacy Solutions. All rights reserved. All materials are exclusively owned by Envolve Pharmacy Solutions and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Envolve Pharmacy Solutions. You may not alter or remove any trademark, copyright or other notice contained herein. Page 5 of 5