Cost-effectiveness of cladribine tablets versus fingolimod in patients with highly active relapsing multiple sclerosis in Portugal

Abstract

Aims: To assess the cost-utility of cladribine tablets versus fingolimod in patients with highly active relapsing-remitting multiple sclerosis (RRMS) in Portugal. Methods: A 1-year cycle cohort-based Markov state transition model was developed to simulate disease progression, measured by Kurtzke Expanded Disability Status Scale (EDSS), relapses, and conversion to secondary-progressive MS (SPMS). Patients were assumed to remain on treatment until progression to EDSS level 7, conversion to SPMS, or complete loss of efficacy due to waning effect. Natural history was based on British Columbia Multiple Sclerosis registry, London Ontario database, UK MS Trust, and cladribine tablets clinical trial (CLARITY). Portuguese all-cause mortality was adjusted for the MS associated increased mortality. Clinical inputs for active treatments (disability progression and relapse rate) were estimated on a network meta-analysis. Utility weights were derived from UK-MS Survey and published literature. Resource consumption by EDSS and due to relapses was based on published literature, National DRG microdata and expert opinion. Unit costs were obtained from official sources. The analysis was conducted from payers' perspective, time horizon of 50 years and discount rate of 5%, for both costs and benefits. Uncertainty was assessed via probabilistic and deterministic sensitivity analyses. Results: Compared to fingolimod, cladribine tablets were associated with a delay in progression, resulting in a gain of 0.85 quality adjusted life years (QALYs) and a cost decrease of 25,935 e. Probabilistic sensitivity analysis resulted in a mean ICER of À31,781 e per QALY and was dominant in 98.7% of the simulations. Cladribine tablets were dominant across the scenario analyses tested. Conclusions: Treatment of highly active RRMS with cladribine tablets was less costly and more effective than treatment with fingolimod. Hence, it is a dominant strategy in the Portuguese setting. No conclusions can be drawn from the present study regarding other treatment options, in particular natalizumab and alemtuzumab.

Cost-effectiveness analysis of rituximab versus natalizumab in patients with relapsing remitting multiple sclerosis

“…The results also showed that doing sensitivity analysis did not change the status of rituximab as the most effective drug regimen, suggesting the robust study results. In this regard, the present study is in line with those of Rezaei et al (2019) and Taheri et al (2019) in the country, and Walter et al (2018), Hettle et al (2018), and Montgomery et al (2017) abroad [ 37 , 61 , 62 , 72 , 73 ].…”

“…Montgomery et al [ 73 ] in the UK examined the cost-effectiveness of fingolimod and natalizumab and found that the cost of the former was £ 334,897.93 and its obtained QALY was 6.18. However, the cost and QALY of the latter were £ 337,501.15 and 6.35, respectively.…”

Cost-utility and cost-effectiveness analysis of disease-modifying drugs of relapsing–remitting multiple sclerosis: a systematic review

“…Fig. 1 Flow chart of the study selection process using a 31-health-state Markov model [43], one study conducted CEA using a 5-year cohort-based Markov model [44], one study conducted CEA using a 1-year cycle cohort-based Markov state transition model [45], one study conducted CEA using a lifetime Markov model [46], five studies conducted CEA [2,[47][48][49][50], two studies conducted both CEA and CBA [10,51], one study conducted CEA using simulation model [52], one study conducted CEA using a treatment-sequence model [53], one study conducted CUA and budget impact analysis (BIA) using a Markov state transition model [54], one study conducted CEA using a published Markov structure with health states based on the Expanded Disability Status Scale (EDSS) [55], one study conducted CEA using a Markov state transition model [56], one study conducted CEA using a Markov economic model [57], five studies conducted CEA using a cohort Markov economic model [10,13,17,51,58], one study conducted CEA using a microsimulation model [19], one study conducted CEA using a discrete-time Markov model [59], one study condcuted CEA using a cohort-based multi-state Markov model [60], and one study conducted CEA using a probabilistic Markov model (second-order Monte Carlo simulation) [61] (Table 2).…”

“…One study was conducted from the UK societal cost perspective [22], two from UK National Health Service [2,58], one from UK third-party payer perspective [55], two from Canadian healthcare system perspective [13,59], one from Chilean health care public sector perspective [38], one from Kingdom of Saudi Arabia payer's perspective [56], two from Payer perspective [34,45], one from the Colombian healthcare system perspective [57], one from Italian societal perspective [28], one from Italian National Healthcare System perspective [60], one study from Swiss health insurance perspective [30], one from Payer and societal perspective [17], eleven studies from societal perspective [19, 27, 29, 31-33, 35, 42-44, 51], three studies from Ministry of Health perspective [50,52,64], one from Third-party payer perspective [23], one from Saudi payer perspective [24], two from US payer perspective [18,37], one from US health care payer perspective [47], one from both National Health Service and Personal Social Services perspective [25], two from Spanish National Health System [39,61], one from thirdparty payer perspective [63], one from both patients and third-party payers perspective [26], one from healthcare perspective [36], one from public healthcare perspective [49], one from both National Health Service and Personal Social Services perspective [41], one from both thirdparty payer & Societal [46], and one from Finnish payer perspective and Scenario analysis with a societal perspective [10], one from both health economics and societal perspective…”

Cladribine Tablets for Relapsing–Remitting Multiple Sclerosis: A Clinician’s Review

“…A simulation model assessing the efficiency of cladribine tablets or DMTs delivered by infusion from a facility perspective in the UK found that cladribine tablets could decrease the burden of hospital-based administration and monitoring [ 78 ]. However, the cost of DMTs is an important driver in many cost-assessment models, and cladribine tablets has been found to be cost effective compared to alternative treatments in modeling based on use in many country-specific settings, including Finland [ 79 ], Portugal [ 80 ], Spain [ 81 ], Saudi Arabia [ 82 ], Chile [ 83 ], Iran [ 84 ], and Poland [ 85 ].…”