| Summary: | Safinamide mesylate is a monoamine oxidase B (MAO-B) inhibitor used as an add-on therapy to a regimen that includes levodopa for the treatment of the signs and symptoms of idiopathic Parkinson disease (PD) in patients experiencing OFF episodes while on a stable dose of levodopa. It is available as 50 mg and 100 mg tablets at a submitted price of $6.90 per tablet, regardless of strength. The recommended starting dose of safinamide is 50 mg daily, which may be increased to 100 mg daily after two weeks based on clinical need and tolerability. The sponsor submitted a cost-utility analysis comparing safinamide 100 mg with multiple comparators that included MAO-B inhibitors (rasagiline, selegiline), catechol -Omethyltransferase inhibitors (entacapone), and dopamine agonists (bromocriptine, pramipexole, ropinirole, rotigotine) as adjunct therapies to levodopa. The sponsor's base case was a probabilistic analysis conducted from the perspective of a Canadian publicly funded health care payer over a 10-year time horizon, with costs and benefits discounted at a rate of 1.5% per annum. The model consisted of 18 mutually exclusive health states: 16 base health states were based on four categories of waking time spent in an OFF state applied to four Hoehn and Yahr (H&Y) stages (stages 2 to 5) and the remaining two health states were discontinuation due to adverse events (AEs) followed by a treatment switch, and death
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