Clinical Policy: (Avastin) Reference Number: ERX.SPMN.127 Effective Date: 03/14 Last Review Date: 09/16 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 bevacizumab (Avastin ) is medically necessary when the following criteria are met: I. Initial Approval Criteria A. FDA Approved Indications (must meet all): 1. Age 18 years; 2. Diagnosis of one of the following: a. Colorectal cancer: i. Cancer is metastatic; ii. Avastin is being used as one of the following: 1. First- or second-line treatment in combination with intravenous 5- fluorouracil-based chemotherapy; 2. Second-line treatment in combination with fluoropyrimidineirinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy after disease progression on a first-line Avastin-containing regimen; iii. Avastin is NOT being used as adjuvant treatment for colon cancer; iv. Prescribed dose does not exceed 10 mg/kg every 2 weeks; b. Non-squamous non-small cell lung cancer: i. Cancer is unresectable, locally advanced, recurrent, or metastatic; ii. Avastin is being used as first-line treatment in combination with carboplatin and paclitaxel; iii. Prescribed dose does not exceed 15 mg/kg every 3 weeks; c. Glioblastoma; i. Cancer is progressive despite prior therapy; ii. Use of Avastin is as a single agent; iii. Prescribed dose does not exceed 10 mg/kg every 2 weeks; d. Renal cell carcinoma: i. Cancer is metastatic; ii. Avastin is being used in combination with interferon alfa; iii. Prescribed dose does not exceed 10 mg/kg every 2 weeks; e. Carcinoma of the cervix: i. Cancer is persistent, recurrent, or metastatic; ii. Avastin is being used in combination with paclitaxel and cisplatin, or paclitaxel and topotecan; iii. Prescribed dose does not exceed 15 mg/kg every 3 weeks; f. Epithelial ovarian, fallopian tube, or primary peritoneal cancer; i. Cancer is platinum-resistant and recurrent; Page 1 of 7
ii. Avastin is being used in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan; iii. Member has received no more than 2 prior chemotherapy regimens; iv. Prescribed dose does not exceed 10 mg/kg every week. Approval duration: 3 months B. Other diagnoses/indications: Refer to ERX.SPMN.16 - Global Biopharm Policy. 1. Off-label use in oncology: a. Age 18 years: i. Breast cancer; ii. Cervical cancer; iii. Colorectal cancer; iv. Endometrial carcinoma; v. Epithelial ovarian, fallopian tube, or primary peritoneal cancer; vi. Kidney cancer; vii. Malignant pleural mesothelioma; viii. Non-small cell lung cancer; ix. Ovarian cancer; x. Primary central nervous system cancers; xi. Soft tissue sarcoma; 2. Off-label use in ophthalmology (intravitreal administration): a. Prescribed as monotherapy (no other anti-vegf medications); b. One of the following indications: i. Retinopathy of prematurity; ii. Age 18 years: 1. Neovascular (wet) age-related macular degeneration; 2. Macular edema following retinal vein occlusion; 3. Diabetic macular edema; 4. Neovascular glaucoma; 5. Choroidal neovascularization associated with: angioid streaks, no known cause, inflammatory conditions, high pathologic myopia, or ocular histoplasmosis syndrome; 6. Ocular neovascularization (choroidal, retinal, iris) associated with proliferative diabetic retinopathy. Approval duration (oncology): 3 months Approval duration (ophthalmology): 6 months II. Continued Approval A. FDA Approved Indications (must meet all): 1. Currently receiving medication via health plan benefit or member has previously met all initial approval criteria. Approval duration: 6 months Page 2 of 7
B. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via health plan benefit and documentation supports positive response to therapy; 2. If use is intravitreal, evidence of treatment efficacy per one of the following: a. Detained neovascularization; b. Improvement in visual acuity; c. Maintenance of corrected visual acuity from prior treatment. Approval duration: 6 months Background Mechanism of Action: 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 reduction of microvascular growth and inhibition of metastatic disease progression. FDA Approved Indications: Avastin (bevacizumab) is a VEGF-specific angiogenesis inhibitor/solution for intravenous infusion indicated for the treatment of: Metastatic colorectal cancer, with intravenous 5-fluorouracil based chemotherapy for first- or second-line treatment.* Metastatic colorectal cancer, with fluoropyrimidine- irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line Avastin containing regimen. Non-squamous non-small cell lung cancer, with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease. Glioblastoma, as a single agent for adult patients with progressive disease following prior therapy. Effectiveness based on improvement in objective response rate. No data available demonstrating improvement in disease-related symptoms or survival with Avastin. Metastatic renal cell carcinoma with interferon alfa. Cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan in persistent, recurrent, or metastatic disease. Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan. *Limitation of use: Avastin is not indicated for adjuvant treatment of colon cancer. Appendices Appendix A: Abbreviation Key FU: fluorouracil VEGF: vascular endothelial growth factor Page 3 of 7
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 Description Codes J9035 Injection, bevacizumab, 10 mg [for non-ophthalmic conditions] C9257 Injection, bevacizumab, 0.25 mg [for ophthalmic conditions only] *CPT Copyright 2013 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. ICD-10-CM Diagnosis Codes that Support Coverage Criteria The following is a list of diagnosis codes that support coverage for the applicable covered procedure code(s). ICD-10-CM Code Description A18.53 Tuberculosis chorioretinitis C17.0-C17.9 Malignant neoplasm of small intestine C18.0-C18.9 Malignant neoplasm of colon C19 Malignant neoplasm of rectosigmoid junction C20 Malignant neoplasm of rectum C48.0-C48.8 Malignant neoplasm of retroperitoneum and peritoneum C49.0-C49.9 Malignant neoplasm of other connective and soft tissue C50.01-C50.92 Malignant neoplasm of breast C53.0-C53.9 Malignant neoplasm of cervix uteri C54.0-C55 Malignant neoplasm of corpus uteri C56.1-C56.9 Malignant neoplasm of ovary C57.0-C57.9 Malignant neoplasm of other and unspecified female genital organs C64.1-C64.9 Malignant neoplasm of kidney, except renal pelvis C65.1-C65.9 Malignant neoplasm of renal pelvis C70.0-C70.9 Malignant neoplasm of meninges C71.0-C71.9 Malignant neoplasm of brain C72.0-C72.9 Malignant of spinal cord, cranial neoplasm nerves and other E08.311, E08.321, E08.331, E08.341, E08.351 E09.311, E09.321, E09.331, E09.341, E09.351 parts of central nervous system Diabetes mellitus due to underlying condition with diabetic retinopathy with macular edema Drug or chemical induced diabetes mellitus with diabetic retinopathy with macular edema Page 4 of 7
ICD-10-CM Code Description E10.311, E10.321, E10.331, E10.341, Type 1 diabetes mellitus with diabetic retinopathy with macular edema E10.351 E11.311, E11.321, E11.331, E11.341, Type 2 diabetes mellitus with diabetic retinopathy with macular edema E11.351 E13.311, E13.321, E13.331, E13.341, Other specified diabetes mellitus with diabetic retinopathy with macular edema E13.351 H16.40 H16.44 Corneal neovascularization H30.001-H30.049 Focal chorioretinal inflammation H30.101-H30.149 Disseminated chorioretinal inflammation H30.891-H30.899 Other chorioretinal inflammations H32 Chorioretinal disorders in diseases classified elsewhere H34.811-H34.819 Central retinal vein occlusion H34.831-H34.839 Tributary (branch) retinal vein occlusion H35.051-H35.059 Retinal neovascularization, unspecified H35.141-H35.169 Retinopathy of prematurity, stages 3 through 5 H35.32 Exudative age-related macular degeneration H35.33 Angioid streaks of macula H35.81 Retinal edema H40.50X0- H40.53X4 Glaucoma secondary to other eye disorders [associated with vascular disorders of eye] H44.20-H44.23 Degenerative myopia Z85.038 Personal history of other malignant neoplasm of large intestine Z85.048 Personal history of other malignant neoplasm of rectum, rectosigmoid junction, and anus Z85.068 Personal history of other malignant neoplasm of small intestine Z85.118 Personal history of other malignant neoplasm of bronchus and lung Z85.3 Personal history of malignant neoplasm of breast Z85.41 Personal history of malignant neoplasm of cervix uteri Z85.42 Personal history of malignant neoplasm of other parts of uterus Z85.43 Personal history of malignant neoplasm of ovary Z85.44 Personal history of malignant neoplasm of other female genital organs Z85.528 Personal history of other malignant neoplasm of kidney Z85.53 Personal history of malignant neoplasm of renal pelvis Z85.841 Personal history of malignant neoplasm of brain Z85.848 Personal history of malignant neoplasm of other parts of nervous tissue Page 5 of 7
Reviews, Revisions, and Approvals Date Approva l Date Policy created. 02/14 03/14 Policy converted to new template. Added FDA-labeled ovarian and cervical cancer indications. Added compendial indications, including ocular uses. Updated criteria per NCCN guidelines for monotherapy or combination therapy and first line or maintenance therapy. Added HCPCS and ICD-10 codes. Criteria: added age and max dose; removed requests for documentation, safety criteria, and prescriber restrictions. References: removed 2008 Genentech letter regarding infections correlating with Avastin intravitreal use as it is no longer available. 07/16 09/16 References 1. Avastin Prescribing Information. South San Francisco, CA: Genentech, Inc.; December 2015. 2. Colon cancer (Version 2.2016). In: National Comprehensive Cancer Network Guidelines. Available at NCCN.org. Accessed March 9, 2016. 3. Rectal cancer (Version 1.2016). In: National Comprehensive Cancer Network Guidelines. Available at NCCN.org. Accessed March 9, 2016. 4. Non-small cell lung cancer (Version 4.2016). In: National Comprehensive Cancer Network Guidelines. Available at NCCN.org. Accessed March 9, 2016. 5. Central nervous system cancers (Version 1.2015). In: National Comprehensive Cancer Network Guidelines. Available at NCCN.org. Accessed March 9, 2016. 6. Kidney cancer (Version 2.2016). In: National Comprehensive Cancer Network Guidelines. Available at NCCN.org. Accessed March 9, 2016. 7. Cervical cancer (Version 1.2016). In: National Comprehensive Cancer Network Guidelines. Available at NCCN.org. Accessed March 9, 2016. 8. Ovarian cancer, including fallopian tube cancer and primary peritoneal cancer (Version 2.2015). In: National Comprehensive Cancer Network Guidelines. Available at NCCN.org. Accessed March 9, 2016. 9.. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at NCCN.org. Accessed March 9, 2016. 10.. In: Micromedex. Ann Arbor, MI: Truven Health Analytics; 2013. Available from: www.micromedexsolutions.com. Accessed March 9, 2016. 11.. In: Clinical Pharmacology. Tampa, FL: Gold Standard; 2008. Available at www.clinicalpharmacology.com. Accessed March 9, 2016. 12.. In: Lexicomp. Hudson, OH: Wolters Kluwer; 2016. Available at www.online.lexi.com. Accessed March 9, 2016. 13. American Academy of Ophthalmology Retina/Vitreous Panel. Preferred Practice Pattern Guidelines. Age-Related Macular Degeneration. San Francisco, CA: American Academy of Ophthalmology; 2015. Available at www.aao.org/ppp. Accessed March 7, 2016. Page 6 of 7
14. American Academy of Ophthalmology Retina/Vitreous Panel. Preferred Practice Pattern Guidelines. Retinal Vein Occlusions. San Francisco, CA: American Academy of Ophthalmology; 2015. Available at www.aao.org/ppp. Accessed March 7, 2016. 15. American Academy of Ophthalmology Retina/Vitreous Panel. Preferred Practice Pattern Guidelines. Diabetic Retinopathy. San Francisco, CA: American Academy of Ophthalmology; 2016. Available at www.aao.org/ppp. Accessed March 7, 2016. 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. 2016 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 7 of 7