Cost-effectiveness of Cladribine Tablets and fingolimod in the treatment of relapsing multiple sclerosis with high disease activity in Spain

Abstract

Objective: To estimate the cost-effectiveness of Cladribine Tablets in the treatment of relapsing multiple sclerosis (RMS) with high disease activity compared with fingolimod, from the perspective of the National Health System (NHS) in Spain. Methods: A Markov model was developed. The annual transition probabilities, were adjusted to patients with RMS with high disease activity. The effect of the treatments compared on the Expanded Disability Status Scale (EDSS) was modeled by hazard ratios for the confirmed progression of disability. The annual relapse rate and the probability of suffering adverse reactions were obtained from a meta-analysis and the literature. The derived costs were calculated from Spanish unit costs. The utilities were obtained from the CLARITY clinical trial and the literature. Deterministic and probabilistic sensitivity analyzes were performed. Results: Cladribine tablets was the dominant treatment: lower costs (−86,536 €) and more effective (+1.11 quality-adjusted life years-QALYs) compared to fingolimod. The probability that Cladribine Tablets was costeffective compared to fingolimod ranged between 94.6% and 96.1% for willingness to pay from € 20,000 to € 30,000 per QALY gained. Conclusions: Cladribine Tablets is a cost-effective treatment, compared to fingolimod, for the treatment of RMS with high disease activity. Expert Opinion: According to the present study, compared to fingolimod, treatment with Cladribine Tablets of relapsing multiple sclerosis with high disease activity is an option that could generate savings for the Spanish National Health System, with a considerable gain in QALYs. Cladribine Tablets is considered cost-effective and dominant (less costs and more effectiveness) than fingolimod treatment option in this population.

Cost Assessment Modelling of Treatments for Highly Active Relapsing Multiple Sclerosis

“…Cladribine tablets were also cost saving in all sensitivity analyses with a 4-year time horizon, even when assuming a sequential approach. These findings are supported by cost estimates from other settings [18][19][20]. The only exception was with the 3-year time horizon, in which fingolimod was €4580 less costly per patient and €1,282,280 less costly in the overall population compared to cladribine tablets.…”

“…In foreign settings and modelled comparisons, cladribine tablets have been observed to be dominant (i.e. lower cost and higher effectiveness) in various settings: compared to fingolimod in Spanish patients with highly active relapsing disease [18], compared to alemtuzumab and natalizumab in English patients with highly active RRMS [19], and compared to alemtuzumab and fingolimod in patients with highly active RRMS as well as compared to natalizumab in patients with rapidly evolving severe disease in the Dutch setting [20]. A cost assessment model (CAM) was developed to project the costs of DMDs for highly active disease in Finland.…”

How have Economic Evaluations in Relapsing Multiple Sclerosis Evolved Over Time? A Systematic Literature Review

“…Geographically, of the 127 included studies, a majority were from the USA (n = 29), followed by the UK (n = 17) and Spain (n = 10) [24,50,53,59,[75][76][77][78][79][80]. HTA reports were mostly from Scotland (n = 11) [29,30,[81][82][83][84][85][86][87][88][89], followed by England (n = 8) [90][91][92][93][94][95][96][97], and Canada (n = 7) [28,[98][99][100][101][102][103] (Fig.…”

“…In the seven-state Markov model, the EDSS state was grouped into few limitations in mobility (EDSS 0.0-2.5), moderate limitations in mobility (EDSS 3.0-5.5), walking aid or wheelchair required (EDSS 6.0-7.5), restricted to bed (EDSS 8.0-9.5), and death (EDSS 10 or natural causes of death). Nine studies [47,78,[119][120][121][122][123][124][125] and three HTA reports [88,97,103] constructed models consisting of 11 health states: ten EDSS states per the EDSS (EDSS 0-9) and one death state. The remaining studies had a Markov model in which the number of states varied between three and 21.…”

“…'Others' ' refers to Asia (China, Iran, Saudi Arabia, Thailand), Brazil, Canada. DMT Disease-modifying therapy, RMS relapsing MS approach was to use data from clinical trials to supplement data from utility studies (n = 9) [67,78,121,125,141,143,157,167,174].…”