OBJECTIVES: To utilize real-world data from the MSBase Registry to estimate the cost-effectiveness of switching to natalizumab (NAT) compared with switching to fingolimod (FTY) in patients with highly-active relapsing-remitting multiple sclerosis (HA-RRMS) with inadequate response to first-line therapies (BRACE-TD) in Italy.
METHODS: The analysis was based on a previously developed Markov model adapted to the Italian societal perspective. The model used health states based on the Expanded Disability Status Scale (EDSS) to capture RRMS disability changes, conversion to secondary progressive MS, and associated relapses. The primary clinical data (EDSS transition matrices, relapse rates, and comparative effectiveness for NAT and FTY) were obtained from MSBase. Local Italian costs for treatment, disease management, relapse, and adverse events were retrieved from national tariffs for drugs and healthcare services and from the published literature. Local Italian data also were used for utilities and general mortality. The analysis estimated lifetime clinical and economic outcomes and the incremental cost per quality-adjusted life-year (QALY) gained from a societal perspective. The impact of alternative model settings and parameter uncertainty was evaluated through scenario and sensitivity analyses.
RESULTS: In the base-case analysis, NAT dominated FTY, leading to higher QALYs (0.560 higher per patient) and lower costs (€1,301 lower per patient). In scenario analysis, NAT remained dominant or maintained an incremental cost-effectiveness ratio less than €30,000/QALY gained except when a 10-year horizon was considered. In probabilistic sensitivity analysis, NAT was dominant in 51.3% of simulations and had an 88.4% probability of being cost-effective at a willingness-to-pay threshold of €30,000/QALY gained.
CONCLUSIONS: This analysis utilising real-world comparative effectiveness data estimated that switching to NAT was more effective and less costly than switching to FTY for the treatment of HA-RRMS patients with inadequate response to BRACE-TD in Italy. Sensitivity analyses suggested that NAT was likely to remain dominant or cost-effective across a range of alternative scenarios.
