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VOLUME X, ISSUE 7 Recently Introduced Products Drug Name Banzel Indication For adjunctive treatment of seizures associated with LennoxGastaut Syndrome in children 4 years and older and adults Potential Impact Expected Avg. Annual Cost $ $613.20 $3,580.65 $: Est. drug plan expenditure increase of <1%* $$: Est. drug plan expenditure increase of 1-5%* $$$: Est. drug plan expenditure increase of >5%* Ozurdex® – Improving Vision in Patients with Central Retinal Vein Occlusion Vision loss may be caused by numerous conditions such as glaucoma, diabetes, stroke, macular edema etc. The macula is the area of the retina responsible for central vision and swelling or thickening in this area results in macular edema. This condition is a common outcome of Central Retinal Vein Occlusion (CRVO) which is caused by the 1 blockage of the central vein that carries blood away from the retina. The reported prevalence of CRVO in the working population (<60 years old) is very low, at approximately 0.04%. There is no cure for this condition, thus the primary goal of treatment is to improve or prevent further loss of visual acuity and reduce macular edema. Currently, there are no approved therapies in Canada; however ranibizumab ® ® (Lucentis ) is commonly used as an off-label treatment. Ozurdex (dexamethasone) is the first biodegradable implant approved by Health Canada for the treatment of macular edema following CRVO. The GENEVA studies concluded that ® Ozurdex can 1) reduce the risk of vision loss and 2) improve the speed and incidence of visual improvement in 2 patients diagnosed with CRVO. ® Ozurdex consists of a specially designed drug delivery system that is injected into the eye by an ophthalmologist. The recommended dose is one implant into the affected eye, and retreatment may occur at an interval of approximately 6 months. Repeat doses are intended for patients who initially respond to treatment but subsequently experience a loss in visual acuity. Retreatment is not necessary for patients that have maintained vision improvement. 2 Based on the history of the disease, patients are not expected to require treatment beyond 3 years. The cost of one ® injection is $1,295 leading to an annual cost of $2,590 and a lifetime cost of up to $7,770. Lucentis is priced at $1,595 per injection and due to a more frequent dosing regimen, the annual cost can lead up to $14,355 and a potential lifetime cost of $43,065 (cost is based on an average of 9 injections per year). ® ClaimSecure will automatically cover Ozurdex for existing open drug formularies and clients that subscribe to Specialty Drug Programs and Stoploss Programs. For clients that subscribe to ClaimSecure’s Managed Formularies, ® ® Ozurdex will be placed under Special Authorization. The Special Authorization program for Ozurdex will ensure that plan members are 1) seen by the appropriate specialists, 2) have a confirmed diagnosis of CRVO, 3) renewals will be granted only for those patients that may benefit from retreatment, and 4) to allow for the possibility of coordination of benefits with available Provincial Drug Programs. ® If you require additional information about Ozurdex please contact Lavina Viegas, Clinical Pharmacist, Clinical Services Department, at (905) 949-3031 or 1-888-479-7587 ext. 3031. Recommendation: Special Authorization ClaimSecure reserves the right to amend in part or in its entirety stated special authorization clinical guidelines 1. 2. References: Retinal Vein Occlusion http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0004583/ Accessed July 22, 2011. Ozurdex® Private Payer Submission. Allergan Inc. June, 2011 * Based on the Financial Impact Analysis per 100 000 lives covered © 2011 ClaimSecure Inc.