EUnetHTA Joint Action 3 WP4 Rapid assessment of other technologies using the HTA Core Model® for Rapid Relative Effectiveness Assessment BIODEGRADABLE RECTUM SPACERS TO REDUCE TOXICITY FOR PROSTATE CANCER Project ID: OTCA23 Version 1, 28 July 2020 This report is part of the project / joint action ‘724130 / EUnetHTA JA3’ which has received funding from the European Union’s Health Programme (2014-2020) Dec2015 ©EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 1 Biodegradable rectum spacers to reduce toxicity for prostate cancer DOCUMENT HISTORY AND CONTRIBUTORS Version Date Description V1.0 01/05/2020 First draft for review by co-authors, dedicated reviewers and search network representative. V1.2 22/05/2020 Input from co-authors, dedicated reviewers and search network representative has been processed. Input from clinical experts, manufacturer and patient partner. Reviewed by co-authors and dedicated reviewers. V1.3 17/06/2020 Input from external experts and SpaceOARTM manufacturer(s) has been processed. Voluntary (not-scheduled) review by co/authors and dedicated reviewers. V1.4 29/06/2020 Input from medical editor has been processed. V1.5 03/07/2020 Input from the technical team (not-scheduled) first review by BarrigelTM manufacturer and second review by SpaceOARTM manufacture. V1.6 14/07/2020 Medical editor final revisions V1.7 28/07/2020 Final edits have been processed. Disclaimer The assessment represents a consolidated view of the EUnetHTA assessment team members and is in no case the official opinion of the participating institutions or individuals. EUnetHTA Joint Action 3 is supported by a grant from the European Commission. The sole responsibility for the content of this document lies with the authors and neither the European Commission nor EUnetHTA are responsible for any use that may be made of the information contained therein. Assessment team Author(s) The Norwegian Institute of Public Health (NIPHNO), Norway Julia Bidonde, Stijn Van de Velde Co-Author(s) National School of Public Health, Management and Professional Development (NSPHMPDB); Romania Marius Ciutan, Cristian Vladescu, Geta Popovici, Silvia Florescu Dedicated State Health Care Accreditation Agency under the Ministry of Health Reviewer(s) of the Republic of Lithuania (VASPVT), Lithuania Vitalija Mazgelė, Kristina Grigaite Swiss Network for HTA (SNHTA), Switzerland Heike Raatz, Matthias Menig National Institute for Health and Care Excellence (NICE); United Kingdom Rebecca Brookfield, Neil Hewitt Version 1.7, 28 July 2020 EUnetHTA Joint Action 3 WP4 2 Biodegradable rectum spacers to reduce toxicity for prostate cancer Project The Norwegian Institute of Public Health (NIPHNO), Norway manager Julia Bidonde Further contributors External clinical experts (listed below) provided input to the development of the Project Plan and provided advice to the assessment team during the assessment. Mr Daniel Ask (patient partner) provided input to the technical team during the development of the Project Plan and Draft Assessment. The project was advertised on EUnetHTA social media for patient organizations (or individual patients interested) and on each of the dedicated reviewers’ and co-authors’ networks. We received input from Prostate Scotland. We used this information in our Project Plan including important considerations and patient relevant outcomes. We also reached out to producers of CE- approved biodegradable rectum spacer devices used during prostate cancer radiotherapy. The table below lists the manufacturers that were contacted and provided feedback on the draft project plan and/or the draft assessment. Ingrid Harboe, information specialist from NIPHNO developed the search strategy and conducted the search. Marco Knelangen, research associate from Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG), critically appraised this search strategy and reviewed the information retrieval process. Consultation of the draft Rapid Assessment External experts v 1.2 Torgrim Tandstad, MD, PhD (Norway) Juliette Thariat, MD (France) Manufacturer(s) v1.2 and v1.5 Participants, TM (factual accuracy check) SpaceOAR System manufactured by Boston Scientific BarrigelTM manufactured by Palette Life Science Non-participant ProSpace system (balloon) manufactured by ProSpace Medical editor v1.2 and v-1.5 Semantix Norway Patient(s)/ patient Daniel Ask organization(s)/ citizens v1.2 Adam Gain, Prostate Scotland Conflict of interest All authors, co-authors, dedicated reviewers, external experts (health care professionals, patients or patient representatives) involved in the production of this assessment have declared they have no conflicts of interest in relation to the technology and comparator(s) assessed according to the EUnetHTA declaration of interest (DOI) form, which was evaluated following the EUnetHTA Procedure Guidance for handling DOI form (https://eunethta.eu/doi). How to cite this assessment Please cite this assessment as follows: Norwegian Institute of Public Health (NIPHNO), National School of Public Health, Management and Professional Development (NSPHMPDB); et al. Biodegradable rectum spacers to reduce toxicity for prostate cancer. Collaborative Assessment. Oslo, Norway: EUnetHTA; 2020. Report No.: OTCA23. This document is available on the website of EUnetHTA. Version 1.7, 28 July 2020 EUnetHTA Joint Action 3 WP4 3 Biodegradable rectum spacers to reduce toxicity for prostate cancer TABLE OF CONTENTS DOCUMENT HISTORY AND CONTRIBUTORS ............................................................................ 2 TABLE OF CONTENTS ................................................................................................................... 4 LIST OF TABLES AND FIGURES .................................................................................................. 5 LIST OF ABBREVIATIONS ............................................................................................................. 8 SUMMARY OF RELATIVE EFFECTIVENESS OF BIODEGRADABLE RECTUM SPACERS TO REDUCE TOXICITY FOR PROSTATE CANCER .......................................... 10 SCOPE ....................................................................................................................................... 10 INTRODUCTION ........................................................................................................................... 10 METHODS .................................................................................................................................. 10 RESULTS.................................................................................................................................... 11 DISCUSSION ............................................................................................................................... 23 CONCLUSION .............................................................................................................................. 24 1 SCOPE ..................................................................................................................................... 25 1.1 DESCRIPTION ..................................................................................................................... 25 1.2 RATING OF THE IMPORTANCE OF OUTCOMES FOR DECISION MAKING ...................................... 27 2 METHODS AND EVIDENCE INCLUDED ............................................................................... 29 2.1 ASSESSMENT TEAM ............................................................................................................ 29 2.2 SOURCE OF ASSESSMENT ELEMENTS .................................................................................. 29 2.3 SEARCH ............................................................................................................................. 29 2.4 STUDY SELECTION .............................................................................................................. 32 2.5 DATA EXTRACTION AND ANALYSES ...................................................................................... 34 2.6 QUALITY RATING ................................................................................................................ 35 2.7 PATIENT INVOLVEMENT ....................................................................................................... 35 2.8 DESCRIPTION OF THE EVIDENCE USED ................................................................................. 36 2.9 DEVIATIONS FROM PROJECT PLAN ....................................................................................... 36 3 DESCRIPTION AND TECHNICAL CHARACTERISTICS OF TECHNOLOGY (TEC) ........... 37 3.1 RESEARCH QUESTIONS ....................................................................................................... 37 3.2 RESULTS ........................................................................................................................... 37 4 HEALTH PROBLEM AND CURRENT USE OF THE TECHNOLOGY (CUR) ....................... 47 4.1 RESEARCH QUESTIONS ....................................................................................................... 47 4.2 RESULTS ........................................................................................................................... 47 5 CLINICAL EFFECTIVENESS (EFF) ....................................................................................... 63 5.1 RESEARCH QUESTIONS ......................................................................................................