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Comparative effectiveness and cost-effectiveness of natalizumab and fingolimod in rapidly evolving severe relapsing-remitting multiple sclerosis in the United Kingdom

T. Spelman, WL. Herring, C. Acosta, R. Hyde, VG. Jokubaitis, E. Pucci, A. Lugaresi, G. Laureys, EK. Havrdova, D. Horakova, G. Izquierdo, S. Eichau, S. Ozakbas, R. Alroughani, T. Kalincik, P. Duquette, M. Girard, T. Petersen, F. Patti, T. Csepany,...

. 2024 ; 27 (1) : 109-125. [pub] 20231226

Jazyk angličtina Země Anglie, Velká Británie

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc24000101

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.

Aarhus University Hospital Arhus C Denmark

Academic MS Center Zuyd Department of Neurology Zuyderland Medical Center Sittard Geleen The Netherlands

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 Center of Clinical Neuroscience 1st Faculty of Medicine Charles University and General University Hospital Prague Czech Republic

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 Galdakao Usansolo University Hospital Osakidetza Basque Health Service Galdakao Spain

Department of Neurology Hospital Clinico San Carlos Madrid Spain

Department of Neurology Hospital Universitario Virgen Macarena Seville Spain

Department of Neurology LR18SP03 and Clinical Investigation Center Neurosciences and Mental Health Razi University Hospital Mannouba Tunis Tunisia

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

Neuro Rive Sud Quebec Canada

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 MS Centre Hasselt Pelt and Noorderhart Rehabilitation and MS Pelt and Hasselt University Hasselt Belgium

University of Queensland Brisbane Australia

UOS Sclerosi Multipla AOU Policlinico G Rodloico San Marco University of Catania Italy

Value and Access Biogen Baar Switzerland

Westmead Hospital Sydney Australia

Citace poskytuje Crossref.org

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$a Comparative effectiveness and cost-effectiveness of natalizumab and fingolimod in rapidly evolving severe relapsing-remitting multiple sclerosis in the United Kingdom / $c T. Spelman, WL. Herring, C. Acosta, R. Hyde, VG. Jokubaitis, E. Pucci, A. Lugaresi, G. Laureys, EK. Havrdova, D. Horakova, G. Izquierdo, S. Eichau, S. Ozakbas, R. Alroughani, T. Kalincik, P. Duquette, M. Girard, T. Petersen, F. Patti, T. Csepany, F. Granella, F. Grand'Maison, D. Ferraro, R. Karabudak, M. Jose Sa, M. Trojano, V. van Pesch, B. Van Wijmeersch, E. Cartechini, P. McCombe, O. Gerlach, D. Spitaleri, C. Rozsa, S. Hodgkinson, R. Bergamaschi, R. Gouider, A. Soysal, . Castillo-Triviño, J. Prevost, J. Garber, K. de Gans, R. Ampapa, M. Simo, JL. Sanchez-Menoyo, G. Iuliano, A. Sas, A. van der Walt, N. John, O. Gray, S. Hughes, G. De Luca, M. Onofrj, K. Buzzard, O. Skibina, M. Terzi, M. Slee, C. Solaro, . Oreja-Guevara, C. Ramo-Tello, Y. Fragoso, V. Shaygannejad, F. Moore, C. Rajda, E. Aguera Morales, H. Butzkueven
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$a 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.
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