| Summary: | Siponimod (Mayzent) is a sphingosine 1-phosphate receptor modulator. This submission relates to the Health Canada-approved indication for the treatment of adults with secondary-progressive multiple sclerosis (SPMS) with active disease, evidenced by relapses or imaging features characteristic of multiple sclerosis (MS) inflammatory activity, to delay the progression of physical disability. Siponimod is available as 0.25 mg and 2 mg film-coated tablets. Treatment has to be initiated over five days: dose titration starts with 0.25 mg once daily on day 1 and day 2, followed by once daily doses of 0.5 mg on day 3 (two tablets of 0.25 mg), 0.75 mg on day 4 (three tablets of 0.25 mg), and 1.25 mg on day 5 (five tablets of 0.25 mg), to reach the maintenance dose of 2 mg siponimod. If a titration dose is missed on one day during the first six days of treatment, treatment needs to be re-initiated. At the submitted prices of $22.39 per 0.25 mg and $89.32 per 2 mg tablet, the first-year costs of treatment are $32,444 and $32,622 annually thereafter. Prior to Health Canada approval and the determination of the indication, the sponsor submitted a cost-utility analysis based on a Markov state-transition model comparing siponimod with interferons (IFNs) (Extavia, Rebif, Avonex, and Betaseron) in adults with SPMS. On request, the sponsor provided a model that included best supportive care (BSC) to fully explore the cost-effectiveness of siponimod. BSC consists of therapies used to control SPMS symptoms and does not include therapies that would alter disease progression. These non-pharmacological therapies that are used to manage SPMS symptoms would also be received by those who are receiving siponimod. Following Health Canada approval for siponimod restricted to adults with active disease, the sponsor submitted an additional analysis with revised parameter estimates and inclusion of natalizumab as a further comparator
|
|---|