Lucentis® (ranibizumab) is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (362.52).

The recommended dosage regimen of ranibizumab is 0.5 mg (0.05 mL) to be administered by intravitreal injection once a month.

Although less effective, treatment may be reduced to one injection every three months after the first four injections if monthly injections are not feasible. Compared to continued monthly dosing, dosing every 3 months will lead to an approximate 5-letter (1-line) loss of visual acuity benefit, on average, over the following 9 months. Patients should be evaluated regularly.

The use of ranibizumab for any indication other than neovascular (wet) age-related macular degeneration is considered experimental/investigational, and therefore, not covered. A participating, preferred, or network provider can bill the member for the denied service.

NOTE:

Coverage for ranibizumab is determined according to individual or group customer benefits.

Description

Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. Ranibizumab binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A). VEGF-A has been shown to cause neovascularization and leakage in models of ocular angiogenesis and is thought to contribute to the progression of the neovascular form of age-related macular degeneration (AMD). 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.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or live-threatening condition and when medically necessary and appropriate for the patient's condition.

Lucentis® (ranibizumab injection)[package insert]. Genentech, Inc., South San Francisco, CA. 04/2008.

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Regillo CD, Brown DM, Abraham P, Yeu H, et al. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: Pier study year 1. Am J Ophthalmol. 2008;145:239-248.

Antoszyk AN, Tuomi L, Chung CY, et al. Ranibizumab combined with verteporfin photodynamic therapy in neovascular age-related macular degeneration (FOCUS): year 2 results. Am J of Ophthalmol. 2008;145:862-874.