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Filgotinib for Moderate to Severe Rheumatoid Arthritis

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Filgotinib for Moderate to Severe Rheumatoid Arthritis “ in collaboration with: Filgotinib for moderate to severe rheumatoid arthritis Produced by Kleijnen Systematic Reviews Ltd. in collaboration with Erasmus University Rotterdam (EUR) and Maastricht University Authors Rob Riemsma, Reviews Manager, Kleijnen Systematic Reviews Ltd, UK Sabine Grimm, Health Economist, Maastricht UMC, the Netherlands Ben Wijnen, Health Economist, Maastricht UMC Debra Fayter, Systematic Reviewer, KSR Ltd Sue O’Meara, Systematic Reviewer, KSR Ltd Nigel Armstrong, Health Economist, KSR Ltd Charlotte Ahmadu, Health Economist, KSR Ltd Lloyd Brandts, Health Economist, Maastricht UMC Gill Worthy, Statistician, KSR Ltd Kate Misso, Information Specialist, KSR Ltd John Kirwan, Emeritus Professor of Rheumatic Diseases, University of Bristol Manuela Joore, Health Economist, Maastricht UMC Jos Kleijnen, Director, KSR Ltd, Professor of Systematic Reviews in Health Care, Maastricht University Correspondence to Rob Riemsma, Kleijnen Systematic Reviews Unit 6, Escrick Business Park Riccall Road, Escrick York, UK YO19 6FD Date completed 28/07/2020 Copyright 2021 Queen's Printer and Controller of HMSO. All rights reserved. CONFIDENTIAL UNTIL PUBLISHED Source of funding: This report was commissioned by the NIHR Systematic Reviews Programme as project number STA 13/14/25. Declared competing interests of the authors None. Acknowledgements None. Commercial in confidence (CiC) data are highlighted in blue throughout the report. Academic in confidence (AiC) data are highlighted in yellow throughout the report. Copyright belongs to Kleijnen Systematic Reviews Ltd. Rider on responsibility for report The views expressed in this report are those of the authors and not necessarily those of the NIHR Systematic Reviews Programme. Any errors are the responsibility of the authors. This report should be referenced as follows: Riemsma R, Grimm S, Wijnen B, Fayter D, O’Meara S, Armstrong N, Ahmadu C, Brandts L, Worthy G, Misso K, Kirwan J, Joore MA, Kleijnen J. Filgotinib for moderate to severe rheumatoid arthritis: a Single Technology Assessment. York: Kleijnen Systematic Reviews Ltd, 2020. Contributions of authors Rob Riemsma acted as project lead and systematic reviewer on this assessment, critiqued the clinical effectiveness methods and evidence and contributed to the writing of the report. Sabine Grimm acted as health economic project lead, critiqued the company’s economic evaluation and contributed to the writing of the report. Ben Wijnen, Lloyd Brandts, Charlotte Ahmadu and Nigel Armstrong acted as health economists on this assessment, critiqued the company’s economic evaluation and contributed to the writing of the report. Debra Fayter and Sue O’Meara acted as systematic reviewers, critiqued the clinical effectiveness methods and evidence and contributed to the writing of the report. Gill Worthy acted as statistician, critiqued the analyses in the company’s submission and contributed to the writing of the report. Kate Misso critiqued the search methods in the submission and contributed to the writing of the report. John Kirwan provided clinical expert advice and contributed to the writing of the report. Manuela Joore acted as health economist on this assessment, critiqued the company’s economic evaluation, contributed to the writing of the report and provided general guidance. Jos Kleijnen critiqued the company’s definition of the decision problem and their description of the underlying health problem and current service provision, contributed to the writing of the report and supervised the project. 2 Copyright 2021 Queen's Printer and Controller of HMSO. All rights reserved. CONFIDENTIAL UNTIL PUBLISHED Abbreviations ABA Abatacept ACPA Anti-citrullinated protein antibodies ACR American College of Rheumatology ADA Adalimumab AE Adverse events AIC Akaike Information Criterion AIMS Arthritis Impact Measurement Scales ATP Adenosine triphosphate BAR Baricitinib bDMARD Biological disease modifying antirheumatic drugs BSC Best supportive care BI Budget impact BIC Bayesian information criterion CCP Cyclic citrullinated peptide CDAI Clinical disease activity index cDMARDs Conventional disease modifying antirheumatic drugs CE Cost effectiveness CEA Cost effectiveness analysis CEAC Cost effectiveness acceptability curve CHMP Committee for Medicinal Products for Human Use CI Confidence interval CRD Centre for Reviews and Dissemination CS Company’s submission CSA Clinically suspect arthralgia csDMARDs Conventional synthetic DMARDs (same as cDMARD) CSR Clinical study report CVD Cardiovascular disease CZP Certolizumab pegol DALY Disability-adjusted life years DAS Disease activity score DMARD Disease modifying antirheumatic drugs DSU Decision Support Unit EMA European Medicines Agency EMEA Europe, Middle East and Africa EPAR European Public Assessment Report EQ-5D European Quality of Life-5 Dimensions ERAN Early rheumatoid arthritis network ERG Evidence Review Group ESR Erythrocyte sedimentation rate ET Early termination ETA Etanercept EULAR European League Against Rheumatism EUR Erasmus University Rotterdam FACIT-F Functional assessment of chronic illness therapy FAD Final appraisal document FDA Food and Drug Administration GOL Golimumab HAQ Health assessment questionnaire HAQ-DI Health Assessment Questionnaire Disability Index HR Hazard ratio HRQoL Health-related quality of life HTA Health technology assessment IC Indirect comparison 3 Copyright 2021 Queen's Printer and Controller of HMSO. All rights reserved. CONFIDENTIAL UNTIL PUBLISHED ICER Incremental cost effectiveness ratio IC50 Half maximal inhibitory concentration IFX Infliximab IR Inadequate response ITC Indirect treatment comparison ITT Intention to treat JAK Janus kinase KSR Kleijnen Systematic Reviews LYs Life years LYG Life years gained MACE Major adverse cardiovascular events MCS Mental component of the SF-36 survey MeSH Medical subject headings MHRA Medicines and Healthcare Products Regulatory Agency MTX Methotrexate MTA Multiple technology appraisal NA Not applicable NHS National Health Service NICE National Institute for Health and Care Excellence NIHR National Institute for Health Research NMA Network meta-analysis NR Not reported OS Overall survival PAS Patient access scheme PCS Physical component of the SF-36 survey PDUS Power Doppler ultrasound PRESS Peer Review of Electronic Search Strategies PRISMA Preferred reporting items for systematic reviews and meta-analyses PSA Probabilistic sensitivity analysis PSS Personal Social Services QALY Quality-adjusted life year QoL Quality of life RA Rheumatoid arthritis RCT Randomised controlled trial RF Rheumatoid factor RR Relative risk; risk ratio RTX Rituximab SAE Serious adverse events ScHARR School of Health and Related Research SD Standard deviation SDAI Simplified disease activity index SE Standard error SF-36 36-item Short Form Survey SLR Systematic literature review SMC Scottish Medicines Consortium SmPC Summary of product characteristics STA Single technology appraisal STATs Signal transducers and activators of transcription TA Technology appraisal TEAE Treatment emergent adverse events TNF Tumor Necrosis Factor TOC Tocilizumab TOF Tofacitinib tsDMARDs Targeted synthetic DMARDs TTO Time trade-off 4 Copyright 2021 Queen's Printer and Controller of HMSO. All rights reserved. CONFIDENTIAL UNTIL PUBLISHED UK United Kingdom ULN Upper limit of normal UMC University Medical Centre USA United States of America WHO World Health Organization WTP Willingness-to-pay 5 Copyright 2021 Queen's Printer and Controller of HMSO. All rights reserved. CONFIDENTIAL UNTIL PUBLISHED Table of Contents Abbreviations .................................................................................................................................... 3 Table of Tables .................................................................................................................................. 8 Table of Figures .............................................................................................................................. 12 1. SUMMARY ................................................................................................................................ 13 1.1 Critique of the decision problem in the company’s submission .......................................... 13 1.2 Summary of the key issues in the clinical effectiveness evidence ...................................... 13 1.3 Summary of the key issues in the cost effectiveness evidence ............................................ 15 1.4 Summary of the ERG’s preferred assumptions and resulting ICER ................................... 17 1.5 Summary of exploratory and sensitivity analyses undertaken by the ERG ......................... 17 2. BACKGROUND......................................................................................................................... 20 2.1 Introduction ......................................................................................................................... 20 2.2 Critique of company’s description of the underlying health problem ................................. 20 2.3 Critique of company’s overview of current service provision ............................................ 22 3. CRITIQUE OF COMPANY’S DEFINITION OF DECISION PROBLEM ........................ 26 3.1 Population ............................................................................................................................ 32 3.2 Intervention .........................................................................................................................
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