| Summary: | This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada. [...] The parameters that had the largest impact on the manufacturer's base case were: reducing the time horizon to two years, conducting the analysis from the societal perspective, varying the duration of alemtuzumab efficacy, and using the data for confirmation of disease progression (CDP) at 24 weeks. [...] In addition, the manufacturer's NMA did not adequately explore the potential impact of clinical heterogeneity across included studies on the estimates of treatment effect, and there was a lack of statistical analysis for inconsistency, which brings into question the reliability of the synthesized evidence. [...] The modifications made to the manufacturer-submitted model include the following: continuation of treatment effect and accrual of treatment costs was based on the same assumptions for all modelled comparators confirmation period for disability progression was modified to 24 weeks annual cost of daclizumab was updated to 27,700 the London, Ontario, data set was used for modelling natural h [...] Issues for Consideration Potential for off-label use in patients with primary-progressive MS: Ocrelizumab has been approved by the US FDA and by the Australian Therapeutic Goods Administration (TGA) for the treatment of primary-progressive and relapsing forms of MS; it is the first agent approved for the treatment of primary-progressive MS.
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