Comparative effectiveness and cost-effectiveness of natalizumab and fingolimod in rapidly evolving severe relapsing-remitting multiple sclerosis in the United Kingdom
Jazyk angličtina Země Anglie, Velká Británie Médium print-electronic
Typ dokumentu časopisecké články
- Klíčová slova
- I, I1, I10, I11, Multiple sclerosis, comparative effectiveness, cost-effectiveness, fingolimod, natalizumab, real-world data,
- MeSH
- analýza nákladové efektivity MeSH
- analýza nákladů a výnosů MeSH
- fingolimod hydrochlorid terapeutické užití MeSH
- imunosupresiva terapeutické užití MeSH
- lidé MeSH
- natalizumab terapeutické užití MeSH
- relabující-remitující roztroušená skleróza * farmakoterapie MeSH
- roztroušená skleróza * farmakoterapie MeSH
- státní lékařství MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Spojené království MeSH
- Názvy látek
- fingolimod hydrochlorid MeSH
- imunosupresiva MeSH
- natalizumab MeSH
AIM: To evaluate the real-world comparative effectiveness and the cost-effectiveness, from a UK National Health Service perspective, of natalizumab versus fingolimod in patients with rapidly evolving severe relapsing-remitting multiple sclerosis (RES-RRMS). METHODS: Real-world data from the MSBase Registry were obtained for patients with RES-RRMS who were previously either naive to disease-modifying therapies or had been treated with interferon-based therapies, glatiramer acetate, dimethyl fumarate, or teriflunomide (collectively known as BRACETD). Matched cohorts were selected by 3-way multinomial propensity score matching, and the annualized relapse rate (ARR) and 6-month-confirmed disability worsening (CDW6M) and improvement (CDI6M) were compared between treatment groups. Comparative effectiveness results were used in a cost-effectiveness model comparing natalizumab and fingolimod, using an established Markov structure over a lifetime horizon with health states based on the Expanded Disability Status Scale. Additional model data sources included the UK MS Survey 2015, published literature, and publicly available sources. RESULTS: In the comparative effectiveness analysis, we found a significantly lower ARR for patients starting natalizumab compared with fingolimod (rate ratio [RR] = 0.65; 95% confidence interval [CI], 0.57-0.73) or BRACETD (RR = 0.46; 95% CI, 0.42-0.53). Similarly, CDI6M was higher for patients starting natalizumab compared with fingolimod (hazard ratio [HR] = 1.25; 95% CI, 1.01-1.55) and BRACETD (HR = 1.46; 95% CI, 1.16-1.85). In patients starting fingolimod, we found a lower ARR (RR = 0.72; 95% CI, 0.65-0.80) compared with starting BRACETD, but no difference in CDI6M (HR = 1.17; 95% CI, 0.91-1.50). Differences in CDW6M were not found between the treatment groups. In the base-case cost-effectiveness analysis, natalizumab dominated fingolimod (0.302 higher quality-adjusted life-years [QALYs] and £17,141 lower predicted lifetime costs). Similar cost-effectiveness results were observed across sensitivity analyses. CONCLUSIONS: This MSBase Registry analysis suggests that natalizumab improves clinical outcomes when compared with fingolimod, which translates to higher QALYs and lower costs in UK patients with RES-RRMS.
There are several medications used to treat people with relapsing remitting multiple sclerosis, such as interferon-based therapies (Betaferon/Betaseron (US), Rebif, Avonex, Extavia), glatiramer acetate (Copaxone), teriflunomide (Aubagio), and dimethyl fumarate (Tecfidera), collectively named BRACETD. Other treatments for multiple sclerosis (MS) have a narrower use, such as natalizumab (Tysabri) or fingolimod (Gilenya), among others.This study objective was to assess how well natalizumab and fingolimod helped treating MS (clinical effectiveness) and subsequently estimate what the cost of these treatments is in comparison to the benefit they bring to people with rapidly evolving severe MS that use them in the United Kingdom (UK) (cost-effectiveness).We used an international disease registry (MSBase), which collects clinical data from people with MS in various centers around the world to compare the effectiveness of natalizumab, fingolimod and BRACETD treatments. We used a technique called propensity score matching to obtain results from comparable patient groups. People treated with natalizumab had better disease control, namely with fewer relapses and higher improvement on their disability level, than patients on fingolimod or BRACETD. Conversely, there were no differences between each group of people on a measure called disability worsening.Based on these clinical results, we built an economic model that simulates the lifetime costs and consequences of treating people with MS with natalizumab in comparison with fingolimod. We found that using natalizumab was less costly and was more effective compared to using fingolimod in UK patients.
Aarhus University Hospital Arhus C Denmark
Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati Avellino Avellino Italy
Bakirkoy Education and Research Hospital for Psychiatric and Neurological Diseases Istanbul Turkey
Biocruces Bizkaia Health Research Institute Spain
CHUM and Universite de Montreal Montreal Canada
Cliniques Universitaires Saint Luc Brussels Belgium
CORe Department of Medicine University of Melbourne Melbourne Australia
CSSS Saint Jérôme Saint Jerome Canada
Department of Clinical Neuroscience Karolinska Institute Stockholm Sweden
Department of General Medicine Parma University Hospital Parma Italy
Department of Medical and Surgical Sciences and Advanced Technologies GF Ingrassia Catania Italy
Department of Medicine and Surgery University of Cordoba Cordoba Spain
Department of Medicine and Surgery University of Parma Parma Italy
Department of Neurobiology Care Sciences and Society Karolinska Institute Stockholm Sweden
Department of Neurology and Stroke BAZ County Hospital Miskolc Hungary
Department of Neurology ASL3 Genovese Genova Italy
Department of Neurology Box Hill Hospital Melbourne Australia
Department of Neurology Centro Hospitalar Universitario de Sao Joao Porto Portugal
Department of Neurology Faculty of Medicine University of Debrecen Debrecen Hungary
Department of Neurology Hospital Clinico San Carlos Madrid Spain
Department of Neurology Hospital Universitario Virgen Macarena Seville Spain
Department of Neurology McGill University Montreal Canada
Department of Neurology Monash Health Clayton Australia
Department of Neurology Semmelweis University Budapest Budapest Hungary
Department of Neurology The Alfred Hospital Melbourne Australia
Department of Neurology University Hospital Ghent Ghent Belgium
Department of Neurology University of Szeged Szeged Hungary
Department of Neuroscience Azienda Ospedaliera Universitaria Modena Italy
Department of Neuroscience Central Clinical School Monash University Melbourne Australia
Department of Neuroscience Hospital Germans Trias i Pujol Badalona Spain
Department of Neuroscience Imaging and Clinical Sciences University G d'Annunzio Chieti Italy
Department of Neurosciences Box Hill Hospital Melbourne Australia
Department of Rehabilitation ML Novarese Hospital Moncrivello
Dipartamento di Scienze Biomediche e Neuromotorie Università di Bologna Bologna Italy
Division of Neurology Department of Medicine Amiri Hospital Sharq Kuwait
Faculty of Health Sciences University Fernando Pessoa Porto Portugal
Faculty of Medicine of Tunis University of Tunis El Manar Tunis Tunisia
Flinders University Adelaide Australia
Groene Hart Ziekenhuis Gouda Netherlands
Hacettepe University Ankara Turkey
Health Economics RTI Health Solutions NC USA
Hospital Universitario Donostia and IIS Biodonostia San Sebastián Spain
Immune Tolerance Laboratory Ingham Institute and Department of Medicine UNSW Sydney Australia
IRCCS Istituto delle Scienze Neurologiche di Bologna Bologna Italy
IRCCS Mondino Foundation Pavia Italy
Isfahan University of Medical Sciences Isfahan Iran
Izmir University of Economics Medical Point Hospital Izmir Turkey
Jahn Ferenc Teaching Hospital Budapest Hungary
Maimonides Biomedical Research Institute of Cordoba
Medical Biogen Baar Switzerland
Medical Faculty 19 Mayis University Samsun Turkey
Monash University Clayton Australia
Monash University Melbourne Australia
MS Centre Neurology Unit SS Annunziata University Hospital University G d'Annunzio Chieti Italy
MS Centre Royal Melbourne Hospital Melbourne Australia
MSBase Foundation Melbourne VIC Australia
Nemocnice Jihlava Jihlava Czech Republic
Neuroimmunology Centre Department of Neurology Royal Melbourne Hospital Melbourne Australia
Neurology Unit AST Fermo Fermo Italy
Neurology unit AST Macerata Macerata Italy
Ospedali Riuniti di Salerno Salerno Italy
Royal Brisbane and Women's Hospital Herston Australia
Royal Victoria Hospital Belfast United Kingdom
School for Mental Health and Neuroscience Maastricht University Maastricht The Netherlands
School of Medicine University of Bari Bari Italy
South Eastern HSC Trust Belfast United Kingdom
Universidade Metropolitana de Santos Santos Brazil
Université Catholique de Louvain Belgium
University of Queensland Brisbane Australia
UOS Sclerosi Multipla AOU Policlinico G Rodloico San Marco University of Catania Italy
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