RIVASTIGMINE ORAL

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Rivastigmine - Dementia (Alzheimer's type) Rivastigmine - Dementia (Alzheimer's type) CEDAC FINAL RECOMMENDATION on RECONSIDERATION and REASONS for RECOMMENDATION RIVASTIGMINE PATCH (Exelon ™ Patch – Novartis Pharmaceuticals Canada Inc.) Description: Exelon ™ Patch contains rivastigmine, a reversible cholinesterase inhibitor that is approved for the symptomatic treatment of patients with mild to moderate dementia of the Alzheimer's type. Dosage Forms: Exelon Patch 5 contains 9 mg/5 cm 2 and releases 4.6 mg/24 hours. Exelon Patch 10 contains 18 mg/10 cm 2 and releases 9.5 mg/24 hours. The recommended dose is one patch applied daily. Recommendation: The Canadian Expert Drug Advisory Committee (CEDAC) recommends that Exelon Patch not be listed. Reasons for the Recommendation: 1. Compared with placebo, Exelon Patch results in statistically significant, but clinically very small differences in some of the outcomes measures considered important in Alzheimer’s disease. 2. Exelon Patch is associated with a higher incidence of treatment-related adverse events when compared with placebo. 3. The Committee had concerns regarding the cost-effectiveness of Exelon Patch relative to best supportive care. Summary of Committee Considerations: The Committee considered a systematic review of double-blind randomized controlled trials (RCTs) in patients with mild to moderate dementia of the Alzheimer’s type. One trial of 24 weeks duration comparing Exelon Patch 10 with oral rivastigmine 6 mg given twice daily or placebo met the inclusion criteria for the systematic review. Outcome measures for patients treated with Exelon Patch 10 and rivastigmine oral were similar.