Analysis of the Recent HTA Decision Making Landscape for Multiple Sclerosis Therapies - Trends and Future Opportunities.

evidence were extracted. Results: Our search identified 19 submissions, all of which included a placebo-controlled trial, and all except dimethyl fumarate also included a head-to-head trial against one of the beta-interferons but not any other therapies. Indirect comparisons against old and newer DMTs were also included in the submissions. Approximately 90% of appraisals received positive recommendations; reasons for positive recommendations included recognition that there is a need for additional treatment options in MS, particularly for patients who do not have an adequate response to beta-interferons, and that oral DMTs represent an innovative step in the treatment of MS. However, submissions were generally criticised for trial design, scarcity of head-to-head trials, use of EDSS to measure disability, the uncertainty regarding long-term clinical and economic outcomes, and the heterogeneity of trial populations included in indirect comparisons. ConClusions: Due to the changing treatment landscape and the population included in MS trials, it is clear that placebo-controlled trials and the inclusion of beta-interferon trials in indirect comparisons are becoming less suitable for the evaluation of new MS treatments. Future HTA submissions will need to take into account the need to demonstrate superiority over comparators, and manufacturers and regulators will need to work together to develop new and reliable measures that can evaluate MS symptoms and impairments in the context of DMTs.