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Age-Related Macular Degeneration (Amd) EUnetHTA Joint Action 3 WP4 Relative effectiveness assessment of pharmaceutical technologies BROLUCIZUMAB FOR THE TREATMENT OF ADULTS WITH NEOVASCULAR (WET) AGE-RELATED MACULAR DEGENERATION (AMD) Project ID: PTJA09 Version 1.0, 12/03/2020 Dec2015 ©EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 1 PTJA09 - Brolucizumab for patients with neovascular (wet) AMD DOCUMENT HISTORY AND CONTRIBUTORS Version Date Description V0.1 28/01/2020 First draft V0.2 24/2/2020 Input from dedicated reviewers has been processed V0.3 10/03/2020 Input from medical editor and manufacturer(s) has been processed V1.0 12/03/2020 Final assessment report Disclaimer This Joint Assessment is part of the project / joint action ‘724130 / EUnetHTA JA3’ which has received funding from the European Union’s Health Programme (2014-2020). The content of this Assessment Report represents a consolidated view based on the consensus within the Authoring Team; it cannot be considered to reflect the views of the European Network for Health Technology Assessment (EUnetHTA), EUnetHTA’s participating institutions, the European Commission and/or the Consumers, Health, Agriculture and Food Executive Agency or any other body of the European Union. The European Commission and the Agency do not accept any responsibility for use that may be made of the information it contains. Assessment team Author(s) Finnish Medicines Agency (Fimea), Finland Co-Author(s) Spanish Agency of Medicine and Sanitary Products (AEMPS), Spain Andalusian Unit for Health Technology Assessment (AETSA), Spain Dedicated French National Authority for Health (HAS), France Reviewer(s) Agency for Health Technology Assessment and Tariff System (AOTMiT), Poland Regione Emilia-Romagna (RER), Italy Association of Austrian Social Insurance Institutions (DVSV), Austria Observer HTA Department/EC Ukraine, Ukraine March 2020 EUnetHTA Joint Action 3 WP4 1 PTJA09 - Brolucizumab for patients with neovascular (wet) AMD Further contributors External experts Prof. João Barbosa Breda Answer specific question during the assessment Manufacturer(s) [v0.2] Novartis Preparation of the submission dossier Factual accuracy check Medical editor [v0.2] Compuscript Limited Responsible for medical editing of the report Patient(s) / patient organisation(s) / citizens Asociación Acción Visión España Provided input in response to the open call for patients (Spain) Input published on 20th May, 2019 Društvo MDSS Kranj (Slovenia) Fighting Blindness (Ireland) Macula Retina (Spain) Retina Bulgaria (Bulgaria) Retina International (Ireland) Retina Suisse (Swiss Confederation) Project Management Zorginstituut Nederland (ZIN), Coordination between involved parties throughout the assessment Netherlands Other [v0.1] EUnetHTA Senior Scientific Officer Support for the systematic literature review Giovanni Tafuri Conflict of interest All authors and dedicated reviewers involved in the production of this assessment have declared they have no conflicts of interest in relation to the technology assessed according to the EUnetHTA Declaration of Interest and Confidentiality Agreement forms. How to cite this assessment Please cite this assessment as follows: EUnetHTA PTJA09. Authoring Team. Relative Effectiveness Assessment of pharmaceutical technologies. Brolucizumab for the treatment of adults with neovascular (wet) age-related macular degeneration (AMD). Joint Assessment. Diemen (The Netherlands): EUnetHTA; 2020. [date of citation]. 124 pages. Report No.: PTJA09. Available from: https //www.eunethta.eu March 2020 EUnetHTA Joint Action 3 WP4 2 PTJA09 - Brolucizumab for patients with neovascular (wet) AMD TABLE OF CONTENTS DOCUMENT HISTORY AND CONTRIBUTORS ............................................................................... 1 TABLE OF CONTENTS ................................................................................................................... 3 LIST OF TABLES AND FIGURES.................................................................................................... 5 LIST OF ABBREVIATIONS.............................................................................................................. 8 EXECUTIVE SUMMARY OF THE ASSESSMENT OF BROLUCIZUMAB ...................................... 10 INTRODUCTION ........................................................................................................................... 10 OBJECTIVE AND SCOPE................................................................................................................ 10 METHODS .................................................................................................................................. 10 RESULTS ................................................................................................................................... 11 DISCUSSION ............................................................................................................................... 14 CONCLUSIONS ............................................................................................................................ 15 1 BACKGROUND ....................................................................................................................... 16 1.1 OVERVIEW OF THE DISEASE OR HEALTH CONDITION .................................................................. 16 1.2 CURRENT CLINICAL PRACTICE................................................................................................. 17 1.3 FEATURES OF THE INTERVENTION ........................................................................................... 18 2 OBJECTIVE AND SCOPE ....................................................................................................... 21 2.1 DEVIATIONS FROM THE PROJECT PLAN ................................................................................... 21 3 METHODS ............................................................................................................................... 22 3.1 INFORMATION RETRIEVAL ....................................................................................................... 22 3.2 DATA EXTRACTION ................................................................................................................ 25 3.3 ROB ASSESSMENT ................................................................................................................ 25 3.4 EXTERNAL VALIDITY .............................................................................................................. 26 3.5 RESULTS AND ANALYSES FOR THE STUDIES INCLUDED ............................................................... 26 3.6 PATIENT INVOLVEMENT .......................................................................................................... 28 4 RESULTS ................................................................................................................................ 29 4.1 INFORMATION RETRIEVAL ....................................................................................................... 29 4.2 STUDIES INCLUDED IN THE ASSESSMENT .................................................................................. 31 4.3 EXCLUDED STUDIES .............................................................................................................. 35 4.4 CHARACTERISTICS OF THE STUDIES INCLUDED: DIRECT EVIDENCE .............................................. 35 4.5 OUTCOMES INCLUDED ........................................................................................................... 39 4.6 RISK OF BIAS ........................................................................................................................ 40 4.7 EXTERNAL VALIDITY .............................................................................................................. 41 4.8 DIRECT EVIDENCE: RESULTS FOR CLINICAL EFFICACY AND SAFETY .............................................. 42 4.9 DIRECT SUPPORTIVE EVIDENCE: BROLUCIZUMAB 3 MG .............................................................. 60 4.10 DIRECT SUPPORTIVE EVIDENCE: SUMMARY OF THE PHASE II OSPREY STUDY ...................... 61 4.11 INDIRECT EVIDENCE: NMA RESULTS ................................................................................ 62 4.12 LITERATURE REVIEW: EVIDENCE OF BEVACIZUMAB AS A TREATMENT OPTION IN NAMD .......... 67 5 PATIENT INVOLVEMENT ........................................................................................................ 74 6 DISCUSSION ........................................................................................................................... 75 6.1 DIRECT COMPARISONS .......................................................................................................... 75 6.2 INDIRECT COMPARISONS ........................................................................................................ 77 6.3 LITERATURE REVIEW OF BEVACIZUMAB .................................................................................... 77 6.4 PATIENT PERSPECTIVE .......................................................................................................... 77 7 CONCLUSIONS ....................................................................................................................... 78 8 REFERENCES ......................................................................................................................... 79 March 2020 EUnetHTA Joint Action 3 WP4 3 PTJA09 - Brolucizumab for patients with neovascular (wet)
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