Cost-effectiveness of cladribine tablets for the treatment of active relapsing-remitting multiple sclerosis in the United Kingdom

Objective The approved indication of cladribine tablets has recently been expanded in the United Kingdom for the treatment of all adult patients with active relapsing multiple sclerosis. This analysis assessed the cost-effectiveness of cladribine tablets from the perspective of the National Health Service in patients with active relapsing-remitting multiple sclerosis (RRMS).Methods A cohort-based Markov model with 11 health states (10 disability states plus death) was developed. In addition to best supportive care without disease-modifying therapy (DMT), 12 recommended DMTs were included as comparators to cladribine tablets over a 50-year horizon. Treatment effects were modelled using hazard ratios for 6-month confirmed disability progression (CDP); relapses and drug-related adverse events were modelled via annualized relapse rates and event probabilities. Associated costs (inflated to 2023 pounds sterling) and quality-adjusted life year (QALY) losses were discounted at 3.5% annually. Sensitivity analyses were conducted.Results Cladribine tablets were dominant (i.e. less costly and more effective) vs ponesimod, ocrelizumab, ofatumumab, dimethyl fumarate, diroximel fumarate, and teriflunomide in pairwise comparisons. Over a lifetime horizon, the model predicted discounted cost-savings with cladribine tablets vs high-efficacy comparators (ponesimod, ocrelizumab, and ofatumumab). In most scenarios, the cost-savings resulted from lower lifetime drug acquisition costs due to the unique fixed course posology of cladribine tablets, in addition to delayed disease progression. Sensitivity analyses supported the base case that cladribine tablets are cost-effective vs ponesimod, ofatumumab, and ocrelizumab; the main source of uncertainty was related to the large credible intervals associated with 6-month CDP.Conclusions This economic analysis demonstrated that cladribine tablets are a cost-effective treatment option for patients with active RRMS.