Avastin (bevacizumab) DRUG.00028, CG-DRUG-68

Transcription

1 Avastin (bevacizumab) DRUG.00028, CG-DRUG-68 Override(s) Prior Authorization Approval Duration 1 year Medications Avastin (bevacizumab) APPROVAL CRITERIA Requests for Avastin (bevacizumab) may be approved when the following I. Individual is being treated for ANY of the following: A. Established neovascular wet age-related macular degeneration; B. Pseudoxanthoma elasticum; C. Other rare causes of choroidal neovascularization for one or more of the following conditions: 1. Angioid streaks; 2. Choroiditis (including, but not limited to histoplasmosis inducted choroiditis); 3. Degenerative myopia, idiopathic; 4. Retinal dystrophies; 5. Trauma; D. Neovascular glaucoma; E. Macular edema from branch retinal vein occlusion; F. Macular edema from central retinal vein occlusion; G. Diabetic macular edema; H. Retinopathy of prematurity; I. Proliferative diabetic retinopathy with or without diabetic macular edema; J. Radiation retinopathy; II. In the treatment of individuals with metastatic breast carcinoma when all of the following A. HER2-negative breast cancer; AND B. Used in first-line chemotherapy* for treatment of metastatic disease; AND C. Used in combination with paclitaxel or paclitaxel protein-bound. *Note: Hormonal therapy alone is not considered chemotherapy. PAGE 1 of 5 02/19/2018 CRX-ALL

2 III. In the treatment of individuals with a primary central nervous system tumor who have failed radiation therapy when the following A. Avastin is being used in a single line of therapy; AND B. The tumor to be treated is a World Health Organization (WHO) Grade III/IV glioma (includes, but is not limited to): 1. Anaplastic astrocytoma; 2. Anaplastic glioma; 3. Ependymoma, progressive or recurrent; 4. Glioblastoma; 5. Glioblastoma multiforme; 6. High-grade glioma, recurrent; IV. In the treatment of individuals with metastatic cervical cancer when all of the following A. Individual has recurrent, or persistent disease that is not amenable to curative treatment with surgery or radiotherapy; AND B. Avastin is being used in combination with paclitaxel and topotecan, or with paclitaxel and cisplatin chemotherapy; AND C. Avastin is being used in a single line of therapy. V. In the treatment of individuals with metastatic colon, rectal, colorectal, or small bowel adenocarcinoma when the following A. Avastin is being used in combination with 5FU-based chemotherapy, irinotecan or oxaliplatin; AND B. Individual has not progressed on more than two lines of a bevacizumabcontaining chemotherapy agent. VI. In the treatment of individuals with unresectable malignant mesothelioma when the following A. Avastin is used in a first-line combination chemotherapy with cisplatin or carboplatin and pemetrexed; AND B. Individual has an Eastern Cooperative Oncology Group performance status of 0-2 and no history of bleeding or thrombosis. C. Avastin as maintenance therapy in the treatment of individuals with malignant mesothelioma when all of the following 1. Avastin was previously administered as an agent in a first-line combination chemotherapy regimen; AND 2. Avastin is used as a single agent; AND 3. Avastin is used until disease progression*. *Note: Once disease progression has occurred, bevacizumab is not to be re-instituted. VII. In the treatment of individuals with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC) when the following PAGE 2 of 5 02/19/2018

3 A. Avastin is used in first-line combination chemotherapy with platinum-based therapy and a taxanes or pemetrexed; AND B. Individual has an Eastern Cooperative Oncology Group performance status of 0-1 and no history of hemoptysis; C. As maintenance therapy in the treatment of individuals with unresectable, locally advanced, recurrent or metastatic non-squamous, NSCLC when all of the following 1. Avastin was previously administered as an agent in a first-line combination chemotherapy regimen; AND 2. Avastin is being used as a single agent; AND 3. Avastin may be used until disease progression; VIII. In the treatment of individuals with recurrent, metastatic epithelial ovarian cancer, fallopian tube cancer or recurrent primary peritoneal cancer when all of the following A. Avastin is used as a single agent or in combination with other chemotherapy; AND B. Avastin is used in a single line of therapy; AND C. Avastin is used for relapsed or refractory disease; D. As maintenance therapy in individuals with recurrent, metastatic epithelial ovarian cancer, fallopian tube cancer or recurrent primary peritoneal cancer when all of the following 1. Avastin was previously administered as an agent in a first-line combination chemotherapy regiment; AND 2. Avastin is being used as a single agent; AND 3. Avastin may be used until disease progression; IX. In the treatment of individuals with symptomatic post-radiation necrosis of the central nervous system; IX. In the treatment of individuals with renal carcinoma (RCC) when either of the following A. Avastin is being used in first-line treatment of metastatic clear cell RCC in combination with interferon; B. Avastin is being used as a single agent for relapsed or medically unresectable stage IV disease with predominant clear cell histology in individuals who have progressed on prior cytokine therapy; C. Avastin is being used as a single agent for relapsed or medically unresectable stage IV disease with non-clear-cell histology; D. Avastin is being used for relapsed or medically unresectable stage IV non-clear cell RCC (including papillary RCC and hereditary leiomyomatosis and RCC [HLRCC]), in combination with erlotinib or everolimus. X. In the treatment of individuals with angiosarcoma AND is Avastin is used as a single agent; PAGE 3 of 5 02/19/2018

4 XI. In the treatment of individuals with solitary fibrous tumor and hemangiopericytoma and is using Avastin in combination with temozolomide. Avastin (bevacizumab) may not be approved in the treatment of all other conditions when the criteria above are not met, including but not limited to any of the following: I. Adjuvant therapy following surgery for stage II or III adenocarcinoma of the colon; II. Prostate cancer; III. Carcinoid tumors; IV. Metastatic melanoma; V. Metastatic adenocarcinoma of the pancreas; VI. Metastatic breast cancer, second line therapy or greater, for example when progression noted following anthracycline and taxane chemotherapy; VII. VIII. IX. Neurofibromatosis type 2; Treatment of a single condition with concomitant Avastin (bevacizumab) use with other targeted biologic agents (including but not limited to erlotinib, cetuximab, panitumumab, trastuzumab, lapatinib and ziv-aflibercept); When used in combination with the same irinotecan based regimen that was previously used in combination with ziv-aflibercept. Note: Avastin (bevacizumab) has black box warnings for gastrointestinal perforations, surgery and wound healing complications, and hemorrhage. Gastrointestinal perforation, some fatal, has occurred in up to 2.4% of treated individuals. Therapy should be discontinued if gastrointestinal perforation or wound dehiscence occurs. Therapy should be discontinued at least 28 days prior to elective surgery. Initiation of therapy should not occur for at least 28 days after surgery and not until the surgical wound is fully healed. Severe or fatal hemorrhage, including hemoptysis, gastrointestinal bleeding, central nervous system (CNS) hemorrhage, and vaginal bleeding, has occurred up to five-fold more frequently in Avastin-treated individuals. Do not administer to individuals with serious hemorrhage or recent hemoptysis. State name Date effective State Specific Mandates Mandate details (including specific bill if applicable) Key References: Avastin [Product Information]. South San Francisco, CA. Genentech, Inc.; December 6, Available at: Accessed on September 27, Azzoli C, Baker S, Temin S, et al. American Society of Clinical Oncology clinical practice guideline update on chemotherapy for Stage IV non-small-cell lung cancer. J Clin Oncol. 2009; 27(36): Bevacizumab. In: DrugPoints System (electronic version). Truven Health Analytics, Greenwood Village, CO. Updated August 15, Available at: Accessed on September 27, PAGE 4 of 5 02/19/2018

5 Bevacizumab Monograph. Lexicomp Online, American Hospital Formulary Service (AHFS ) Online, Hudson, Ohio, Lexi-Comp., Inc. Last revised September 22, Accessed on September 27, Irshad T, Olencki T, Zynger DL, et al. Bevacizumab in metastatic papillary renal cell carcinoma (PRCC) [abstract]. J Clin Oncol. 2011; 29:e Louis DN, Ohgaki H, Wiestler OD, et al. The 2007 WHO classification of tumours of the central nervous system. Acta Neurophathol. 2007; 114(2): Masters GA, Temin S, Azzoli CG, et al. Systemic therapy for stage IV non-small-cell lung cancer: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2015; 33(30): NCCN Clinical Practice Guidelines in Oncology National Comprehensive Cancer Network, Inc. For additional information: Accessed on September 27, Breast Cancer (V2.2017). Revised April 6, Central Nervous System Cancers (V1.2017). Revised August 18, Cervical Cancer (V1.2017). Revised October 10, Colon Cancer (V2.2017). Revised March 13, Kidney Cancer (V1.2018). Revised September 7, Malignant Pleural Mesothelioma (V1.2017). Revised March 2, Melanoma (V2.2017). Revised July 7, Non-Small Cell Lung Cancer (V8.2017). Revised July 14, Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer (V3.2017). Revised August 30, Pancreatic Adenocarcinoma (V3.2017). Revised September 11, Prostate Cancer (V2.2017). Revised February 21, Rectal Cancer (V3.2017). Revised March 13, Soft Tissue Sarcoma (V2.2017). Revised February 8, Socinski MA, Evans T, Gettinger S, et al. Treatment of stage IV non-small cell lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013; 143(5 Suppl):e341S-e368S. U.S. Food and Drug Administration Drug Safety and Awareness. Updated November Available at: Accessed on September 27, PAGE 5 of 5 02/19/2018