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(Date) ATTN: (Appeals Department/Medical Reviewer ...Date) ATTN: (Appeals Department/Medical Reviewer) (Insurance company name) (Insurance company address) Fax #: Patient: Subscriber

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Page 1: (Date) ATTN: (Appeals Department/Medical Reviewer ...Date) ATTN: (Appeals Department/Medical Reviewer) (Insurance company name) (Insurance company address) Fax #: Patient: Subscriber

(Date) ATTN: (Appeals Department/Medical Reviewer) (Insurance company name) (Insurance company address) Fax #: Patient: Subscriber ID#: Group ID#: Tax ID#: APPEAL REQUEST FOR LUCENTIS™ (Ranibizumab injection) Dear Appeals Reviewer/Committee: (Introductory paragraph) I am writing this appeal letter on behalf of my patient, (patient name), who was denied Lucentis on (date of denial) for his/her treatment of Macular Edema following Retinal Vein Occlusion (RVO). The denial reason stated was (type Insurance Company’s denial reason). I would like to explain my rationale for prescribing Lucentis. I have enclosed medical records, which I believe will support the need for Lucentis. Should you have any hesitation about this request, please have a board-certified ophthalmologist or Medical Director review this matter on an exceptional basis. (Clinical Information/ Patient History) (Provide rationale for treatment which includes a brief description of the patient’s age, visual health, prior treatments and response to treatments. Include any underlying health issues, co-morbidities, social concerns, personal issues and lack of treatment options. Include supporting medical records). (Describe Rationale and treatment Plan) Lucentis (Ranibizumab injection) was approved by the Food and Drug Administration (FDA) on June 22, 2010,for the treatment of the Macular Edema following Retinal Vein Occlusion (RVO) by intravitreal injection. LUCENTIS (ranibizumab injection) is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. Ranibizumab binds to and inhibits the biologic activity of human

Page 2: (Date) ATTN: (Appeals Department/Medical Reviewer ...Date) ATTN: (Appeals Department/Medical Reviewer) (Insurance company name) (Insurance company address) Fax #: Patient: Subscriber

vascular endothelial growth factor A (VEGF-A). Ranibizumab binds to the receptor binding site of active forms of VEGF-A, including the biologically active, cleaved form of this molecule, VEGF110. VEGF-A has been shown to cause neovascularization and leakage in models of ocular angiogenesis and vascular occlusion, and is thought to contribute to the progression of neovascular AMD and macular edema following RVO. The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation. (Consider mentioning experts in the field who support the treatment and enclosing citations and/or articles). LUCENTIS 0.5 mg (0.05 mL) is recommended to be administered by intravitreal injection once a month (approximately 28 days), for the treatment of Macular Edeman following Retinal Vein Occlusion (RVO). In the RVO clinical studies, patients received monthly injections of LUCENTIS for six months. Monthly Lucentis (Ranibizumab injection) was shown to have significant visual acuity improvements and a safety profile demonstrated in patients from the BRAVO and CRUISE trials. Please review this information promptly for authorization of Lucentis treatments. Page 2 Patient name (Conclusion Paragraph) In summary, my patient has Macular Edema following Retinal Vein Occlusion (RVO) (explain how the disease has or could affect your patient). (Summarize the major points in your letter and restate what you want from the insurance company. Include if your patient has already started Lucentis™ and had a positive response.) Thank you for your time and reconsideration in reviewing Lucentis for the treatment of my patient. Sincerely, Physician Name, M.D. Enclosures (suggested): Medical records, Insurance Company Denial Letter, FDA approval letter and Package Insert, clinical study results, citations and/or publications 10460000