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Cost-Effectiveness of Cladribine Tablets and Fingolimod in the Treatment of Relapsing Multiple Sclerosis with High Disease Activity in Spain

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Cost-Effectiveness of Cladribine Tablets and Fingolimod in the Treatment of Relapsing Multiple Sclerosis with High Disease Activity in Spain Expert Review of Pharmacoeconomics & Outcomes Research ISSN: 1473-7167 (Print) 1744-8379 (Online) Journal homepage: https://www.tandfonline.com/loi/ierp20 Cost-effectiveness of Cladribine Tablets and fingolimod in the treatment of relapsing multiple sclerosis with high disease activity in Spain J. L. Poveda, J. L. Trillo, C. Rubio-Terrés, D. Rubio-Rodríguez, A. Polanco & C. Torres To cite this article: J. L. Poveda, J. L. Trillo, C. Rubio-Terrés, D. Rubio-Rodríguez, A. Polanco & C. Torres (2019): Cost-effectiveness of Cladribine Tablets and fingolimod in the treatment of relapsing multiple sclerosis with high disease activity in Spain, Expert Review of Pharmacoeconomics & Outcomes Research, DOI: 10.1080/14737167.2019.1635014 To link to this article: https://doi.org/10.1080/14737167.2019.1635014 © 2019 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. Accepted author version posted online: 21 Jun 2019. Published online: 25 Jul 2019. Submit your article to this journal Article views: 56 View Crossmark data Full Terms & Conditions of access and use can be found at https://www.tandfonline.com/action/journalInformation?journalCode=ierp20 EXPERT REVIEW OF PHARMACOECONOMICS & OUTCOMES RESEARCH https://doi.org/10.1080/14737167.2019.1635014 ORIGINAL RESEARCH Cost-effectiveness of Cladribine Tablets and fingolimod in the treatment of relapsing multiple sclerosis with high disease activity in Spain J. L. Povedaa, J. L. Trillob, C. Rubio-Terrésc, D. Rubio-Rodríguezc, A. Polancod and C. Torresd aPharmacy Department, Hospital Universitario y Politécnico La Fe, Valencia, Spain; bPharmacy Department, Hospital Clínico Universitario de Valencia, Valencia, Spain; cPharmacoeconomics Department, Health Value, Madrid, Spain; dCorporate Affairs Department, Merck, Madrid, Spain ABSTRACT ARTICLE HISTORY Objective: To estimate the cost-effectiveness of Cladribine Tablets in the treatment of relapsing multi- Received 2 May 2019 ple sclerosis (RMS) with high disease activity compared with fingolimod, from the perspective of the Accepted 19 June 2019 National Health System (NHS) in Spain. KEYWORDS Methods: A Markov model was developed. The annual transition probabilities, were adjusted to patients with Cladribine Tablets; RMS with high disease activity. The effect of the treatments compared on the Expanded Disability Status Scale fingolimod; multiple (EDSS) was modeled by hazard ratios for the confirmed progression of disability. The annual relapse rate and sclerosis; relapsing multiple the probability of suffering adverse reactions were obtained from a meta-analysis and the literature. The sclerosis; cost-effectiveness 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 cost- effective 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. 1. Introduction (EMA) has approved fingolimod for the treatment of RMS with high disease activity for the following groups of patients: (i) Multiple sclerosis (MS) is a disease of the central nervous system Patients with highly active disease despite a full and adequate characterized by inflammation, demyelination and degenerative course of treatment with at least one disease modifying therapy; changes [1]. It usually begins at between 20 and 40 years of age and (ii) Patients with rapidly evolving severe relapsing remitting and affects women tree times more as men, being the most multiple sclerosis defined by 2 or more disabling relapses in frequent cause of non-traumatic disability in the young adult one year, and with 1 or more Gadolinium enhancing lesions on population [1,2]. According to three recent studies, the prevalence brain MRI or a significant increase in T2 lesion load as compared to of MS in Spain is estimated at between 65 and 90 cases per 100,000 apreviousrecentMRI[10]. The EMA has also recently approved inhabitants [3–5]. Cladribine Tablets in the treatment of adult patients with RMS with According to a cross-sectional Spanish study [6], 92% and 64% high disease activity defined by clinical or imaging features [11]. of patients with MS analyzed experienced fatigue and cognitive The objective of this study was to assess the cost- problems, respectively, with a mean utility (quality of life as per- effectiveness of both disease-modifying treatments (DMTs), ceived by the patient) of 0.772 and costs per patient per year (from Cladribine Tablets and fingolimod, in the treatment of RMS the societal perspective) ranging between 20,600 € with a score in with high disease activity, from the perspective of the National the Expanded Disability Status Scale (EDSS) of 0 to 3 and 68,700 € Health System (NHS) in Spain. with an EDSS score of 7 to 9. In Spain, the total annual cost of MS has been estimated at 1,4 billion euros (40% direct healthcare cost, 30% direct non-healthcare cost and 30% indirect cost) [7]. 2. Methods The majority of patients with MS, between 85% and 90%, are 2.1. Markov model diagnosed with relapsing MS (RMS) characterized by periods of acute exacerbation (relapses) followed by periods of remission of The characteristics of this model have been published pre- neurological symptoms [6,8,9]. The European Medicines Agency viously [12]. The analysis has been based on a Markov model CONTACT D. Rubio-Rodríguez [email protected] Health Value, Health Economics & Research of Outcomes Consulting, C/Virgen de Aránzazu, 21. 5º B., Madrid 28034, Spain This article has been republished with minor changes. These changes do not impact the academic content of the article. © 2019 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way. 2 J. L. POVEDA ET AL. status); (iii) maintain their status (remain in the EDSS status in Article Highlights which they are); or (iv) die. Table 1 shows the annual probabilities of transition between ● The economic model simulated the evolution of a cohort of patients with relapsing multiple sclerosis (RMS) with high disease activity the EDSS statuses, adjusted to the RMS with high disease activity treated with Cladribine Tablets or fingolimod. [12,16]. Table 2 offers a summary of the other premises and values ● Treatment with Cladribine Tablets was cost-effective, generating adopted in the model [10,12,15,17–33]. At the start of the analysis, lower costs (−86,536 €) and demonstrating greater effectiveness (+1.11 QALYs) than treatment with fingolimod, demonstrating that the cohort of patients was distributed among the different health Cladribine Tablets is a dominant treatment in each patient with RMS statuses (EDSS scores) according to the distribution observed in with high disease activity. the CLARITY phase III clinical study [20]. The population parameters ● The saving was mainly due to the lower drug related cost: acquisition (in line with the Summary of Product Characteristics, Cladribine of the cohort were adjusted to the patients of the CLARITY study, Tablets is administered a maximum of 20 days in two courses of with an average age of 37.1 years[20]. The average body weight treatment), administration (Cladribine Tablets does not require the was adjusted to the specific Spanish population, taking into use of specific health resources for its administration) and monitoring (the use of resources needed to monitor Cladribine Tablets is account the average weight (68 kg) of three Spanish cohorts of reduced). patients with MS (total N = 701) [3,5,34](Table 2). ● The gain in QALYs was due to the delay in Expanded Disability Status It was assumed that patients with EDSS statuses between 0 Scale (EDSS) progression with Cladribine Tablets vs. fingolimod. ● The probability that Cladribine Tablets was cost-effective compared and 6 were receiving treatment with a DMT, unless discontin- to fingolimod ranged between 94.6% and 96.1% for willingness to ued due to tolerability issues or the appearance of relapses € € pay from 20,000 to 30,000 per QALY gained. (development of secondary progressive MS [SPMS]). Patients ● According to the present study, compared to fingolimod, treatment with Cladribine Tablets of RMS with high disease activity is an option with EDSS statuses between 7 and 9 were assumed to not be that could generate savings for the Spanish National Health
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