Bevacizumab (Avastin) Policy Number: Original Effective Date: MM.04.001 09/14/2004 Line(s) of Business: Current Effective Date: HMO; PPO; QUEST 03/01/2014 Section: Prescription Drugs Place(s) of Service: Home I. Description Bevacizumab (Avastin) is FDA approved for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5-fluorouracil-based chemotherapy. Bevacizumab is FDA approved for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel. Bevacizumab is FDA approved for the treatment of glioblastoma with progressive disease following prior therapy as a single agent. Bevacizumab is FDA approved for the treatment of metastatic renal cell carcinoma in combination with interferon alfa. The FDA has withdrawn its approval for metastatic HER2-negative breast cancer however; NCCN continues to recommend (2A) the use of bevacizumab in combination with paclitaxel for recurrent or metastatic disease that is: hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative with visceral crisis HER2-negative and either hormone receptor-negative or hormone receptor-positive and endocrine therapy refractory progressive with no clinical benefit after three consecutive endocrine therapy regimens or with symptomatic visceral disease Bevacizumab is administered by intravenous infusion for cancer indications or intravitreally for macular degeneration. It is a monoclonal antibody that binds vascular endothelial growth factor (VEGF) and prevents interaction of VEGF to its receptors thus preventing the stimulation of new blood vessels.
Bevacizumab (Avastin) 2 II. Criteria/Guidelines A. Bevacizumab is covered (subject to Limitation/Exclusions and Administrative Guidelines) when recommended by an oncologist and the following criteria are met: 1. For treatment of metastatic cancer of the colon and/or rectum when used as first or second line treatment in combination with other chemotherapeutic agent(s). 2. For treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer: a. Bevacizumab must be used as first line treatment. b. Bevacizumab must be used in combination with carboplatin (Paraplatin) and paclitaxel (Taxol). c. Bevacizumab may be used as monotherapy after four to six cycles in combination with paclitaxel and carboplatin until there is disease progression or unacceptable toxicity. 3. For treatment of HER2 negative metastatic breast cancer in combination with paclitaxel for recurrent or metastatic disease that is: a. Hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative with visceral crisis. b. HER2-negative and either hormone receptor-negative or hormone receptor-positive and endocrine therapy refractory. c. Progressive with no clinical benefit after three consecutive endocrine therapy regimens or with symptomatic visceral disease. 4. For treatment of kidney cancer, bevacizumab must be used in combination with interferon alfa. 5. For treatment of ovarian cancer, HMSA follows NCCN level 1 or 2A and/or DrugDex level I or IIa recommendations. 6. For glioblastoma, bevacizumab must be used in progressive disease following prior therapy as a single agent. B. For all indications, HMSA follows NCCN level 1 or 2A and/or DrugDex level I or IIa recommendations. C. Patients with cancer whose therapy has been interrupted due to surgery or other medical complications not related to bevacizumab are eligible for continued therapy if the above criteria are met. D. Continuation of therapy is covered (subject to Limitations/Exclusions and Administrative Guidelines) when the initial therapy has been approved and the patient shows no progression of disease while on bevacizumab, except for colorectal cancer, HMSA follows NCCN level 1 or 2A and/or DrugDex level I or IIa recommendations. E. Bevacizumab is covered for the following ophthalmic indications: 1. Treatment of neovascular (wet) age-related macular degeneration. 2. Choroid neovascular membrane (CNVM) or choroidal neovascularization (CNV) secondary to myopia. 3. Macular edema following retinal vein occlusion. 4. Diabetic. III. Limitations/Exclusions
Bevacizumab (Avastin) 3 For oncology indications, with the exception of colorectal cancer, bevacizumab is not covered for a patient who has had progression of disease while on bevacizumab. For colorectal cancer, HMSA follows NCCN level 1 or 2A and/or DrugDex level I or IIa recommendations. IV. Administrative Guidelines A. Precertification is required for the initial three months of therapy for the treatment of cancer. To precertify, please complete HMSA's Drug Review Request and mail or fax the form as indicated. The following documentation must be submitted: 1. Clinical notes that include the history of previous treatments 2. Current oncology notes 3. Pathology reports 4. Imaging studies 5. CEA for colorectal cancer B. Precertification is required for continuation of therapy for up to an additional three months. The following documentation from the medical record must be submitted: 1. Current oncology notes documenting the patient's response to treatment and that show no progression of disease, with the exception of colorectal cancer. 2. Objective findings demonstrating no progression of disease (i.e., CEA and/or imaging) when compared to previous studies, with the exception of colorectal cancer. C. Precertification is not required for bevacizumab when it is prescribed for ophthalmic indications listed above in II.E. and when the following codes are used to reflect the covered ophthalmic indications. All other indications require precertification. Precertification is required for the following: HCPCS Code J9035 Description Injection, bevacizumab, 10 mg Precertification is not required when bevacizumab is prescribed for ophthalmic indications; use HCPCS code J3590 with the following ICD-9 codes for ophthalmic indications: ICD-9 code Description 362.52 Exudative senile macular degeneration 360.21 Progressive high (degenerative) myopia, when billed with: 362.16 Retinal neovascularization NOS 362.35 Central retinal vein occlusion
Bevacizumab (Avastin) 4 362.36 Venous tributary (branch) occlusion 362.07 Diabetic ICD-10 codes are provided for your information. These will not become effective until 10/1/2014. ICD9 Code Description H35.32 Exudative age-related macular degeneration H44.20 Degenerative myopia, unspecified eye H44.21 Degenerative myopia, right eye H44.22 Degenerative myopia, left eye H44.23 Degenerative myopia, bilateral when billed with: H35.051 Retinal neovascularization, unspecified, right eye H35.052 Retinal neovascularization, unspecified, left eye H35.053 Retinal neovascularization, unspecified, bilateral H35.059 Retinal neovascularization, unspecified, unspecified eye H34.811 Central retinal vein occlusion, right eye H34.812 Central retinal vein occlusion, left eye H34.813 Central retinal vein occlusion, bilateral H34.819 Central retinal vein occlusion, unspecified eye when billed with H34.831 Tributary (branch) retinal vein occlusion, right eye H34.832 Tributary (branch) retinal vein occlusion, left eye H34.833 Tributary (branch) retinal vein occlusion, bilateral H34.839 Tributary (branch) retinal vein occlusion, unspecified eye E08.311 Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with E08.321 Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with E08.331 Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with E08.341 Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with E08.351 Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with E09.311 Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy with
Bevacizumab (Avastin) 5 E09.321 Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with E09.331 Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with E09.341 Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with E09.351 Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with E10.311 Type 1 diabetes mellitus with unspecified diabetic retinopathy with E10.321 Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with E10.331 Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with E10.341 Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with E10.351 Type 1 diabetes mellitus with proliferative diabetic retinopathy with E11.311 Type 2 diabetes mellitus with unspecified diabetic retinopathy with E11.321 Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with E11.331 Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with E11.341 Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with E11.351 Type 2 diabetes mellitus with proliferative diabetic retinopathy with E13.311 Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema E13.321 Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with E13.331 Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with E13.341 Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with E13.351 Other specified diabetes mellitus with proliferative diabetic retinopathy with V. Important Reminder
Bevacizumab (Avastin) 6 The purpose of this Medical Policy is to provide a guide to coverage. This Medical Policy is not intended to dictate to providers how to practice medicine. Nothing in this Medical Policy is intended to discourage or prohibit providing other medical advice or treatment deemed appropriate by the treating physician. Benefit determinations are subject to applicable member contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control. This Medical Policy has been developed through consideration of the medical necessity criteria under Hawaii s Patients Bill of Rights and Responsibilities Act (Hawaii Revised Statutes 432E-1.4), generally accepted standards of medical practice and review of medical literature and government approval status. HMSA has determined that services not covered under this Medical Policy will not be medically necessary under Hawaii law in most cases. If a treating physician disagrees with HMSA s determination as to medical necessity in a given case, the physician may request that HMSA reconsider the application of the medical necessity criteria to the case at issue in light of any supporting documentation. VI. References 1. Avastin prescribing information. Genentech, Inc., 3/2013 2. Burger RA, Brady MF, Bookman MA. Et al. Incorporation of Bevacizumab in the treatment of ovarian cancer. N Engl J Med 2011; 365:2473-83. 3. DrugDex Evaluations. Bevacizumab Clinical Applications. Last modified: September 24, 2013. 4. Hurwitz H, Fehrenbacher L, Novotny W, et al: Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 2004; 350(23):2335-2342. 5. Miller K, Wang M, Gralow J, et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N. Eng J Med. 357; 26, December 27, 2007. 6. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Breast cancer. Version 3.2013 7. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Colon cancer. Version 2. 2014 8. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Kidney cancer. Version 1.2013 9. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Central nervous system cancers. Version 2.2013 10. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Non small cell lung cancer. Version 2.2013 11. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Ovarian cancer including fallopian tube cancer and primary peritoneal cancer. Version 2.2013 12. Perren TJ, Swart AM, Pfisterer J, et al. A phase 3 trial of bevacizumab in ovarian cancer. N Engl J Med 2011; 365: 2484-96. 13. Sandler, A. et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 355; 24, December 14, 2006.
Bevacizumab (Avastin) 7 14. Thompson Coon J, Hoyle M, Green C, et al. Bevacizumab, sorafenib tosylate, sunitinib and temsirolimus for renal cell carcinoma: a systematic review and economic evaluation. Executive Summary Health Technology Assessment 2010; Volume 14: Number 2. 15. NCCN Drugs and Biologics Compendium. Bevacizumab. 2013 16. CATT Research Group; Martin DF, Maguire MG, Ying GS, Grunwald JE, Fine SL, Jaffe GJ. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med. 2011 May 19; 364(20):1897-908. Epub 2011 Apr 28. 17. Zhu J, Sharma DB, Gray SW, et al. Carboplatin and paclitaxel with vs without bevacizumab in older patients with advanced non small cell lung cancer. JAMA, April 18, 2012. 307: 15; 1593-1601.