Avastin (bevacizumab) (Intravenous/Intravitreal)

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1 (Intravenous/Intravitreal) Date of Origin: 10/17/08 Dates Reviewed: 6/17/2009, 12/22/2009, 03/2010, 06/2010, 09/21/2010, 12/2010, 2/15/2011, 03/2011, 06/2011, 09/2011, 12/2011, 03/2011, 6/19/2012, 09/06/2012, 12/06/2012, 02/07/2013, 03/07/2013, 06/06/2013, 08/01/2013, 09/05/2013, 12/05/2013, 03/25/2014 Prior Auth Available: Post-service edit: The medical necessity criteria were developed by ICORE Healthcare for the purpose of making clinical review determinations for requests for medications commonly used in various diseases. The clinical disciplines of oncology, hematology, rheumatology, neurology, internal medicine, pharmacy and nursing were consulted as part of the criteria development. The development followed an extensive literature search pertaining to established clinical guidelines and accepted prescribing patterns for each individual drug. The indications for the medications are consistent with FDA approved indications, CMS coverage guidelines, National Comprehensive Cancer Network (NCCN) guidelines and/or other published peer reviewed research literature. I. Medication Description: Bevacizumab binds vascular endothelial growth factor (VEGF) and prevents the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells. The interaction of VEGF with its receptors leads to endothelial cell proliferation and new blood vessel formation in in-vitro models of angiogenesis. Administration of bevacizumab to xenotransplant models of colon cancer in nude (athymic) mice caused a reduction of microvascular growth and inhibition of metastatic disease progression II. III. Length of Authorization: Coverage is provided for 6 months and may be renewed Review Criteria: Coverage is provided in the following conditions: Carcinoma of the colon or rectum o Patient s disease is metastatic or unresectable or locally advanced; AND o Must be used in combination with chemotherapy regimen which contains intravenous 5-fluorouracil (5FU) OR intravenous irinotecan (Camptosar) OR oral capecitabine (Xeloda) Metastatic carcinoma of the colon or rectum (after progression on first-line Avastin) o Patient s disease has progressed on a first-line bevacizumab-containing regimen; AND o Used in combination with intravenous 5-fluorouracil (5FU)- irinotecan (Camptosar) based regimen, if not used in first line regimen; OR o Used in combination with intravenous 5-fluorouracil (5FU)-oxaliplatin (Eloxatin) based chemotherapy regimen, if not used in first line regimen; OR o Used in combination with oxaliplatin (Eloxatin) and irinotecan(camptosar), if not used in the first line regimen Non-squamous non-small cell lung cancer o Patient s disease must be recurrent or metastatic; AND o Patient s cancer is nonsquamous cell histology; AND o Patient must have no recent history of recent hemoptysis (the presence of blood in sputum); AND o Must be used as part of a 1 st line chemotherapy regimen; AND Page 1 of 14

2 -ORo -ORo 1. Must be used in combination with with cisplatin- or carboplatin-based regimens; AND 2. Patient must have ECOG performance status 0-1 Must be used as part of a continuation maintenance regimen; AND 1. Avastin must have been included in patient s 1 st line chemotherapy regimen; AND 2. Patient s disease has not progressed (achieved tumor response or stable disease)after 1 st line chemotherapy;and 3. Patient must have ECOG performance status 0-1; AND 4. Must be used as a single agent; OR 5. Must be used in combination with Alimta (pemetrexed) if Avastin was previously used with a first-line pemetrexed/platinum chemotherapy regimen Must be used as part of a 2 nd line chemotherapy regimen; AND 1. Must be used in combination with with platinum-based doublet; AND 2. Patient must have ECOG performance status 0-2; AND 3. Patient s 1 st line therapy regimen must have included either Tarceva (erlotinib) or Xalkori (crizotinib) Cervical Cancer o Patient s disease must be recurrent or metastatic; AND o Must be used as first line therapy in combination with Platinol (cisplatin) or Taxol (paclitaxel) Breast cancer: o Patient must have recurrent or metastatic disease; AND o Patient must be HER2 negative; AND o Must be used in combination with paclitaxel Renal cell carcinoma (First line therapy) o Patient s disease must be relapsed OR unresectable Stage IV; AND o Must be used as first line therapy (patient is treament naïve); AND o Patient s disease has predominant clear cell histology; AND Must be used in combination with Intron-A (interferon alpha -2) -ORo Patient s disease has predominant non- clear cell histology; AND Must be used as a single agent Renal cell carcinoma (Subsequent therapy including 2nd line or greater) o Patient s disease must be relapsed OR unresectable Stage IV; AND o Patient s disease has predominant clear cell histology; AND o Must be used as subsequent single agent therapy; AND o Patient has progressed on previous 1 st line therapy with cytokines (i.e. Proleukin or Intron-A) Primary central nervous system (CNS) cancer - Adult Intracranial Ependymoma o Patient must have progressive disease; AND o Patient s disease cell histology must be Adult Intracranial Ependymoma; AND o Must be used as a single agent; AND o Patient s disease cell histology does NOT include subependymoma and myxopapillary Primary central nervous system (CNS) cancer Anaplastic Gliomas and Glioblastoma Page 2 of 14

3 o Patient s disease cell histology must be Anaplastic Gliomas OR Glioblastoma; AND o Patient s disease is recurrent or patient requires salvage therapy; AND o Must be used as a single agent; OR o Must be used in combination with irinotecan (Camptosar) OR carmustine (BiCNU) OR lomustine (CeeNU) OR temolozomide (Temodar) Ovarian cancer o Patient s disease must be persistent or have recurrence; AND o Must be used as a single agent Soft tissue Sarcoma - Angiosarcoma o Must be used as a single agent for the treatment of angiosarcoma; Soft tissue Sarcoma - Solitary Fibrous Tumor/Hemangiopericytoma o Must be used in combination with temozolomide (Temodar) for the treatment of solitary fibrous tumor and hemangiopericytoma Uterine Neoplasms Endometrial Carcinoma o Must be used as a single agent; AND o Must be 2 nd line or greater therapy Age related wet macular degeneration (AMD) Diabetic macular edema Diabetic Retinopathy Macular edema following retinal vein occlusion FDA-labeled indication(s) IV. Renewal Criteria: Coverage can be renewed based upon the following criteria: Oncology Indications: o Tumor response with stabilization of disease or decrease in size of tumor or tumor spread; AND o Absence of unacceptable toxicity from the drug; OR Metastatic carcinoma of the colon or rectum (additional renewal opportunity): o Patient s disease has progressed on a first-line bevacizumab-containing regimen; AND o Must be used in combination with intravenous 5-fluorouracil (5FU)- irinotecan (Camptosar) based regimen, if not used in first line regimen; OR o Must be used in combination with intravenous 5-fluorouracil (5FU)-oxaliplatin (Eloxatin) based chemotherapy regimen, if not used in first line regimen; OR o Used in combination with oxaliplatin (Eloxatin) and irinotecan(camptosar), if not used in the first line regimen Non-Oncology Indications: o Patient continues to meet criteria identified in section III; AND Page 3 of 14

4 o o Disease response; AND Absence of unacceptable toxicity from the drug V. Dosage/Administration: Indication Cancer Indications Ophthalmic indications Dose 10mg/kg every 2 weeks OR 15mg/kg every 3 weeks 1.25mg in each eye every 4 weeks VI. Billing/Code Information: JCode: J9035 Avastin (Genentech) 100mg, 400mg injection: 1 billable unit = 10mg C (Genentech) 100mg, 400mg injection: 1 billable unit = 0.25mg Max Units (per dose and over time): Oncology indications (J9035): Male: 170 billable units per 21 days Female: 150 billable units per 21 days Ocular indications (C9257): Male/Female: 5 billable units per 28 days per eye Covered Diagnosis: ICD-9 Codes Diagnosis Malignant neoplasm of duodenum Malignant neoplasm of jejunum Malignant neoplasm of ileum Malignant neoplasm of other specified sites of small intestine Malignant neoplasm of small intestine, unspecified site MALIGNANT NEOPLASM OF HEPATIC FLEXURE MALIGNANT NEOPLASM OF TRANSVERSE COLON MALIGNANT NEOPLASM OF DESCENDING COLON MALIGNANT NEOPLASM OF SIGMOID COLON MALIGNANT NEOPLASM OF CECUM MALIGNANT NEOPLASM OF APPENDIX VERMIFORMIS MALIGNANT NEOPLASM OF ASCENDING COLON MALIGNANT NEOPLASM OF SPLENIC FLEXURE MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF LARGE INTESTINE MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION MALIGNANT NEOPLASM OF RECTUM MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS MALIGNANT NEOPLASM OF RETROPERITONEUM Page 4 of 14

5 158.8 Malignant neoplasm of specified parts of peritoneum Malignant neoplasm of peritoneum, unspecified Malignant neoplasm of trachea Malignant neoplasm of main bronchus Malignant neoplasm of upper lobe, bronchus or lung Malignant neoplasm of middle lobe, bronchus or lung Malignant neoplasm of lower lobe, bronchus or lung Malignant neoplasm of other parts of bronchus or lung Malignant neoplasm of bronchus or lung, unspecified MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF HEAD FACE AND NECK MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF UPPER LIMB MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF LOWER LIMB Malignant neoplasm of connective tissue and other soft tissue of thorax MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF ABDOMEN Malignant neoplasm of connective tissue and other soft tissue of pelvis MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF TRUNK UNSPECIFIED MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF CONNECTIVE AND OTHER SOFT TISSUE MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE SITE UNSPECIFIED Malignant neoplasm of nipple and areola of female breast Malignant neoplasm of central portion of female breast Malignant neoplasm of upper-inner quadrant of female breast Malignant neoplasm of lower-inner quadrant of female breast Malignant neoplasm of upper-outer quadrant of female breast Malignant neoplasm of lower-outer quadrant of female breast Malignant neoplasm of axiliary tail of female breast Malignant neoplasm of of other specified sites of female breast Malignant neoplasm of breast (female), unspecified Malignant neoplasm of nipple and areola of male breast Malignant neoplasm of other and unspecified sites of male breast Malignant neoplasm of endocervix Malignant neoplasm of exocervix Malignant neoplasm of other specified sites of cervix Malignant neoplasm of cervix uteri, unspecified site Malignant neoplasm of corpus uteri, except isthmus Malignant neoplasm of of ovary Malignant neoplasm of of fallopian tube Malignant neoplasm of brad ligament of uterus Malignant neoplasm of parametrium Malignant neoplasm of round ligament of uterus Malignant neoplasm of other specified sites of uterine adnexa Malignant neoplasm of uterine adnexa, unspecified site MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS MALIGNANT NEOPLASM OF RENAL PELVIS MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES MALIGNANT NEOPLASM OF FRONTAL LOBE Page 5 of 14

6 191.2 MALIGNANT NEOPLASM OF TEMPORAL LOBE MALIGNANT NEOPLASM OF PARIETAL LOBE MALIGNANT NEOPLASM OF OCCIPITAL LOBE MALIGNANT NEOPLASM OF VENTRICLES MALIGNANT NEOPLASM OF CEREBELLUM NOS MALIGNANT NEOPLASM OF BRAIN STEM MALIGNANT NEOPLASM OF OTHER PARTS OF BRAIN MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF NERVOUS SYSTEM Secondary malignant neoplasm of lung Secondary malignant neoplasm of retroperitoneum and peritoeneum Malignant neoplasm of liver, secondary NEOPLASM OF UNCERTAIN BEHAVIOR OF BRAIN AND SPINAL CORD NEOPLASM OF UNSPECIFIED NATURE OF BONE SOFT TISSUE AND SKIN Background diabetic retinopathy Proliferative diabetic retinopathy Nonproliferative diabetic retinopathy NOS Mild nonproliferative diabetic retinopathy Moderate nonproliferative diabetic retinopathy Severe nonproliferative diabetic retinopathy Diabetic macular edema Retinal vascular occlusion, unspecified Central retinal vein occlusion Venous tributary (branch) occlusion Exudative senile macular degeneration Cystoid macular degeneration Retinal edema V10.05 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF LARGE INTESTINE V10.11 Personal history of maligant neoplasm of bronchus and lung V10.3 Personal history of malignant neoplasm of breast V10.43 Personal history of malignant neoplasm of ovary V10.52 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF KIDNEY V10.85 Personal history of malignant neoplasm of brain V16.49 Family history of malignant neoplasm of other genital organs VII. Centers for Medicare and Medicaid Services (CMS): Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub ), Chapter 15, 50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: Additional indications may be covered at the discretion of the health plan. Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD): Jurisdiction(s): 5, 8 NCD/LCD Document (s): L28576 ICD-9 Codes Diagnosis Page 6 of 14

7 MALIGNANT NEOPLASM SMALL INTESTINE MALIGNANT NEOPLASM SMALL INTESTINE MALIGNANT NEOPLASM SMALL INTESTINE MALIGNANT NEOPLASM OF HEPATIC FLEXURE - MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS MALIGNANT NEOPLASM OF RETROPERITONEUM MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED MALIGNANT NEOPLASM OF MAIN BRONCHUS - MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF HEAD FACE AND NECK - MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE SITE UNSPECIFIED MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE MALIGNANT NEOPLASM OF ENDOCERVIX - MALIGNANT NEOPLASM OF CERVOX UTERI, UNSPECIFIED SITE MALIGNANT NEOPLASM OF OVARY - MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS MALIGNANT NEOPLASM OF RENAL PELVIS MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES - MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE Jurisdiction(s): 5, 8 NCD/LCD Document (s): L32013 ICD-9 Codes Diagnosis HISTOPLASMA CAPSULATUM RETINITIS HISTOPLASMA DUBOISII RETINITIS HISTOPLASMOSIS RETINITIS UNSPECIFIED PROLIFERATIVE DIABETIC RETINOPATHY DIABETIC MACULAR EDEMA RETINAL NEOVASCULARIZATION NOS CENTRAL RETINAL VEIN OCCLUSION VENOUS TRIBUTARY (BRANCH) OCCLUSION OF RETINA EXUDATIVE SENILE MACULAR DEGENERATION OF RETINA CYSTOID MACULAR DEGENERATION OF RETINA RETINAL EDEMA RUBEOSIS IRIDIS GLAUCOMA ASSOCIATED WITH VASCULAR DISORDERS OF EYE Page 7 of 14

8 Jurisdiction(s): 10(J) NCD/LCD Document (s): L30555 ICD-9 Codes Diagnosis HISTOPLASMOSIS RETINITIS UNSPECIFIED PROLIFERATIVE DIABETIC RETINOPATHY SEVERE NONPROLIFERATIVE DIABETIC RETINOPATHY DIABETIC MACULAR EDEMA RETINAL NEOVASCULARIZATION NOS CENTRAL RETINAL VEIN OCCLUSION VENOUS TRIBUTARY (BRANCH) OCCLUSION OF RETINA EXUDATIVE SENILE MACULAR DEGENERATION OF RETINA CYSTOID MACULAR DEGENERATION OF RETINA ANGIOID STREAKS OF CHOROID GLAUCOMA ASSOCIATED WITH VASCULAR DISORDERS OF EYE Jurisdiction(s): 10(J) ICD-9 Codes NCD/LCD Document (s): A48896 Diagnosis MALIGNANT NEOPLASM OF HEPATIC FLEXURE - MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION - MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS MALIGNANT NEOPLASM OF TRACHEA - MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE - MALIGNANT NEOPLASM OF (FEMALE) UNSPECIFIED SITE MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE MALIGNANT NEOPLASM OF OVARY MALIGNANT NEOPLASM OF FALLOPIAN TUBE - MALIGNANT NEOPLASM OF ROUND LIGAMENT OF UTERUS MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF UTERINE ADNEXA MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS MALIGNANT NEOPLASM OF RENAL PELVIS MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES - MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE V10.00 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF UNSPECIFIED SITE IN GASTROINTESTINAL TRACT Page 8 of 14

9 V10.05 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF LARGE INTESTINE V10.06 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF RECTUM RECTOSIGMOID JUNCTION AND ANUS V10.3 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF Jurisdiction(s): F NCD/LCD Document (s): A51786 ICD-9 Codes Diagnosis HISTOPLASMA CAPSULATUM RETINITIS HISTOPLASMA DUBOISII RETINITIS HISTOPLASMOSIS RETINITIS UNSPECIFIED PROGRESSIVE HIGH (DEGENERATIVE) MYOPIA BACKGROUND DIABETIC RETINOPATHY PROLIFERATIVE DIABETIC RETINOPATHY NONPROLIFERATIVE DIABETIC RETINOPATHY NOS MILD NONPROLIFERATIVE DIABETIC RETINOPATHY MODERATE NONPROLIFERATIVE DIABETIC RETINOPATHY SEVERE NONPROLIFERATIVE DIABETIC RETINOPATHY DIABETIC MACULAR EDEMA RETINAL TELANGIECTASIA RETINAL NEOVASCULARIZATION NOS OTHER NONDIABETIC PROLIFERATIVE RETINOPATHY RETINAL VASCULAR OCCLUSION UNSPECIFIED CENTRAL RETINAL VEIN OCCLUSION VENOUS TRIBUTARY (BRANCH) OCCLUSION OF RETINA EXUDATIVE SENILE MACULAR DEGENERATION OF RETINA CYSTOID MACULAR DEGENERATION OF RETINA RETINAL EDEMA RETINAL ISCHEMIA RUBEOSIS IRIDIS GLAUCOMA ASSOCIATED WITH VASCULAR DISORDERS OF EYE OTHER SPECIFIED GLAUCOMA Jurisdiction(s): 6, K NCD/LCD Document (s): A46095 ICD-9 Codes Diagnosis MALIGNANT NEOPLASM OF HEPATIC FLEXURE MALIGNANT NEOPLASM OF TRANSVERSE COLON MALIGNANT NEOPLASM OF DESCENDING COLON MALIGNANT NEOPLASM OF SIGMOID COLON MALIGNANT NEOPLASM OF CECUM MALIGNANT NEOPLASM OF APPENDIX VERMIFORMIS Page 9 of 14

10 153.6 MALIGNANT NEOPLASM OF ASCENDING COLON MALIGNANT NEOPLASM OF SPLENIC FLEXURE MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF LARGE INTESTINE MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION MALIGNANT NEOPLASM OF RECTUM MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS MALIGNANT NEOPLASM OF RETROPERITONEUM MALIGNANT NEOPLASM OF SPECIFIED PARTS OF PERITONEUM MALIGNANT NEOPLASM OF PERITONEUM UNSPECIFIED MALIGNANT NEOPLASM OF TRACHEA MALIGNANT NEOPLASM OF MAIN BRONCHUS MALIGNANT NEOPLASM OF UPPER LOBE BRONCHUS OR LUNG MALIGNANT NEOPLASM OF MIDDLE LOBE BRONCHUS OR LUNG MALIGNANT NEOPLASM OF LOWER LOBE BRONCHUS OR LUNG MALIGNANT NEOPLASM OF OTHER PARTS OF BRONCHUS OR LUNG MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF HEAD FACE AND NECK MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF UPPER LIMB INCLUDING SHOULDER MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF LOWER LIMB INCLUDING HIP MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF ABDOMEN MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE OF TRUNK UNSPECIFIED MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF CONNECTIVE AND OTHER SOFT TISSUE MALIGNANT NEOPLASM OF CONNECTIVE AND OTHER SOFT TISSUE SITE UNSPECIFIED MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE MALIGNANT NEOPLASM OF CENTRAL PORTION OF FEMALE MALIGNANT NEOPLASM OF UPPER-INNER QUADRANT OF FEMALE MALIGNANT NEOPLASM OF LOWER-INNER QUADRANT OF FEMALE MALIGNANT NEOPLASM OF UPPER-OUTER QUADRANT OF FEMALE Page 10 of 14

11 174.5 MALIGNANT NEOPLASM OF LOWER-OUTER QUADRANT OF FEMALE MALIGNANT NEOPLASM OF AXILLARY TAIL OF FEMALE MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF FEMALE MALIGNANT NEOPLASM OF (FEMALE) UNSPECIFIED SITE MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE MALIGNANT NEOPLASM OF OVARY MALIGNANT NEOPLASM OF FALLOPIAN TUBE MALIGNANT NEOPLASM OF BROAD LIGAMENT OF UTERUS MALIGNANT NEOPLASM OF PARAMETRIUM MALIGNANT NEOPLASM OF ROUND LIGAMENT OF UTERUS MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF UTERINE ADNEXA MALIGNANT NEOPLASM OF UTERINE ADNEXA UNSPECIFIED SITE MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS MALIGNANT NEOPLASM OF RENAL PELVIS MALIGNANT NEOPLASM OF CEREBRUM EXCEPT LOBES AND VENTRICLES MALIGNANT NEOPLASM OF FRONTAL LOBE MALIGNANT NEOPLASM OF TEMPORAL LOBE MALIGNANT NEOPLASM OF PARIETAL LOBE MALIGNANT NEOPLASM OF OCCIPITAL LOBE MALIGNANT NEOPLASM OF VENTRICLES MALIGNANT NEOPLASM OF CEREBELLUM NOS MALIGNANT NEOPLASM OF BRAIN STEM MALIGNANT NEOPLASM OF OTHER PARTS OF BRAIN MALIGNANT NEOPLASM OF BRAIN UNSPECIFIED SITE MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF NERVOUS SYSTEM NEOPLASM OF UNCERTAIN BEHAVIOR OF BRAIN AND SPINAL CORD NEOPLASM OF UNSPECIFIED NATURE OF BONE SOFT TISSUE AND SKIN PROLIFERATIVE DIABETIC RETINOPATHY DIABETIC MACULAR EDEMA RETINAL NEOVASCULARIZATION NOS CENTRAL RETINAL VEIN OCCLUSION VENOUS TRIBUTARY (BRANCH) OCCLUSION OF RETINA EXUDATIVE SENILE MACULAR DEGENERATION OF RETINA Page 11 of 14

12 CYSTOID MACULAR DEGENERATION OF RETINA RETINAL EDEMA RUBEOSIS IRIDIS GLAUCOMA ASSOCIATED WITH VASCULAR DISORDERS OF EYE V10.05 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF LARGE INTESTINE V10.06 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF RECTUM RECTOSIGMOID JUNCTION AND ANUS V10.11 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF BRONCHUS AND LUNG V10.3 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF V10.52 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF KIDNEY V10.53 PERSONAL HISTORY OF MALIGNANT NEOPLASM OF RENAL PELVIS Jurisdiction(s): 9(N) NCD/LCD Document (s): L29959, L29961 ICD-9 Codes Diagnosis PROLIFERATIVE DIABETIC RETINOPATHY DIABETIC MACULAR EDEMA RETINAL NEOVASCULARIZATION NOS OTHER NONDIABETIC PROLIFERATIVE RETINOPATHY CENTRAL RETINAL VEIN OCCLUSION VENOUS TRIBUTARY (BRANCH) OCCLUSION OF RETINA EXUDATIVE SENILE MACULAR DEGENERATION OF RETINA CYSTOID MACULAR DEGENERATION OF RETINA RETINAL EDEMA RUBEOSIS IRIDIS GLAUCOMA ASSOCIATED WITH VASCULAR DISORDERS OF EYE VIII. Criteria Exclusions: o Treatment for diagnoses not FDA approved o All indications not described in Section III Review criteria are not covered and may be considered experimental or investigational. IX. Black Box Warnings/Contraindications: Black Box Warnings: o Gastrointestincal perforation o Surgery and wound healing complications o Hemorrhage Contraindications N/A Page 12 of 14

13 X. References: 1. Avastin [package insert]. South San Francisco, CA; Genentech; March Accessed March Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium ) bevacizumab. National Comprehensive Cancer Network, The NCCN Compendium is a derivative work of the NCCN Guidelines. NATIONAL COMPREHENSIVE CANCER NETWORK, NCCN, and NCCN GUIDELINES are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed March American Academy of Ophthalmology Retina/Vitreous Panel. Age-related macular degeneration. San Francisco (CA): American Academy of Ophthalmology (AAO); p. 4. Intravitreal bevacizumab (Avastin ) treatment of macular edema in central retinal vein occlusion: a shortterm study. Retina Mar; 26(3): Epstein DL, Algvere PV, von Wendt G, et al: Bevacizumab for macular edema in central retinal vein occlusion: a prospective, randomized, double-masked clinical study. Ophthalmology 2012; 119(6): Cekic O, Cakir M, Yazici AT, et al: A comparison of three different intravitreal treatment modalities of macular edema due to branch retinal vein occlusion. Curr Eye Res 2010; 35(10): Moradian S, Ahmadieh H, Malihi M, et al. Intravitreal bevacizuab in active progressive proliferative diabetic retinopathy. Graefes Arch Clin Exp Ophthalmol 2008;246: Short-term safety and efficacy of intravitreal bevacizumab (Avastin ) for neovascular age-related macular degeneration. Retina May-Jun; 26(5): Rich RM, Rosenfeld PJ, Puliafito CA, et al. Short-term safety and efficacy of intravitreal bevacizumab (Avastin) for neovascular age-related macular degeneration. Retina 2006;26: Avery RL, Pieramici DJ, Rabena MD, et al. Intravitreal bevacizumab (Avastin) for neovascular age-related macular degeneration. Ophthalmol 2006;113: Wisconsin Physicians Service Insurance Corporation. Local Coverage Determination (LCD) for Chemotherapy Drugs and their Adjuncts (L28576). Centers for Medicare & Medicaid Services, Inc. Updated on 02/19/2014 with effective date 03/01/2014. Accessed March Wisconsin Physicians Service Insurance Corporation Coverage Determinations (LCD) for bevacizumab (L32013). Centers for Medicare & Medicaid Services. Updated on 10/22/2013 with effective date 11/15/2013. Accessed March Cahaba Government Benefit Administrators, LLC Local Coverage Determinations (LCD) for bevacizumab (L30555). Centers for Medicare & Medicaid Services. Updated on 08/29/2013 with effective date 8/10/2012. Accessed March Cahaba Government Benefit Administrators, LLC. Local Coverage Article for Drugs and Biologicals - Chemotherapeutic Agents (A48896). Centers for Medicare & Medicaid Services, Inc. Updated on 10/25/2013 with effective date 11/01/2013. Accessed February Noridian Administrative Services, LLC Articles for bevacizumab (A51786). Centers for Medicare & Medicaid Services. Updated on 10/31/2013 with effective date 11/01/2013. Accessed March National Government Services, Inc. Local Coverage Article for BEVACIZUMAB (e.g., Avastin ) - Related to LCD L25820 (A46095). Centers for Medicare & Medicaid Services, Inc. Updated on 10/23/2013 with effective date 11/01/2013. Accessed March First Coast Service Options, Inc. Local Coverage Determination (LCD) for Intravitreal BEVACIZUMAB (Avastin ) (L29959; L29961). Centers for Medicare & Medicaid Services. Updated on 06/15/2011 with effective date 06/14/2011. Accessed March XI. Appendix: Page 13 of 14

14 Medicare Part B Administrative Contractor (MAC) Jurisdictions Jurisdiction Applicable State/US Territory Contractor E CA,HI, NV, AS, GU, CNMI Noridian Administrative Services (NAS) F AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ Noridian Administrative Services (NAS) 5 KS, NE, IA, MO Wisconsin Physicians Service (WPS) 6 MN, WI, IL National Government Services (NGS) H LA, AR, MS, TX, OK, CO, NM Novitas Solutions 8 MI, IN Wisconsin Physicians Service (WPS) 9 (N) FL, PR, VI First Coast Service Options 10 (J) TN, GA, AL Cahaba Government Benefit Administrators 11 (M) NC, SC, VA, WV Palmetto GBA 12 (L) DE, MD, PA, NJ, DC Novitas Solutions K NY, CT, MA, RI, VT, ME, NH National Government Services (NGS) 15 KY, OH CGS Administrators, LLC Page 14 of 14