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Ramucirumab for the Treatment of Gastric Cancer Rapid EUnetHTA Joint Action 2 (2012-2015) WP5 Strand A, Rapid assessment of pharmaceutical Pilot rapid assessment of pharmaceuticals using the HTA Core Model® for Rapid Relative Effectiveness Assessment RAMUCIRUMAB IN COMBINATION WITH PACLITAXEL AS SECOND-LINE TREATMENT FOR ADULT PATIENTS WITH ADVANCED GASTRIC OR GASTRO-OESOPHAGEAL JUNCTION ADENOCARCINOMA Pilot ID: WP5 – SA4 Final version, March 2015 EUnetHTA JA2 Ramucirumab for advanced gastric or gastro-oesophageal junction adenocarcinoma WP5 DISCLAIMER During the Scoping Phase of this jointly produced rapid Relative Effectiveness Assessments, the manufacturer was asked to compile a EUnetHTA submission file. This submission file includes all important and relevant information regarding the compound under assessment. Within the submission file from the manufacturer on ramucirumab, data was presented regarding indirect comparison and network analyses. This data was planned to be presented within the publicly available EUnetHTA assessment report. During the assessment phase the manufacturer indicated that they wanted to publish the results of the indirect comparison in an abstract for an international conference and the committee responsible for assessing these abstracts indicated that pre-publication of these results in the EUnetHTA report could seriously decrease the chances of these data being accepted. After discussion with the manufacturer, the main authors of this report and the coordinator, it was decided that in order to support the opportunity for the manufacturer to publish this data, until the publication of the abstract results at the international conference, only directions of findings would be presented in this public assessment report. However, it was also indicated that all the results of the indirect comparisons would be immediately shared with all WP5 partners. During the discussion with the manufacturer we had to acknowledge the fact that it was not sufficiently clearly stated in the procedure manual of WP5 Strand A that all information included within the submission file must be available to be used within this public assessment. Moreover, the pilot team felt that a pragmatic approach in the pilot phase of this project would be beneficial to bring these activities forward. However, the coordination team has as a consequence, ensured that the procedure of the REA has been adapted and that it is now clearly stated in all relevant documents that all information included in the submission file must be available for usage in the publicly available rapid Relative Effectiveness Assessments. As EUnetHTA is working based on transparency guidelines it also has been decided that an additional appendix to this assessment report with a complete overview of all data will be published. This appendix will be made publicly available in June 2015. This note is intended to notify the reader of this assessment is aware of the discussed issue and to raise awareness that an additional appendix will be published in June. The assessment represents a consolidated view of the EUnetHTA network members and is in no case the official opinion of the participating institutions or individuals. EUnetHTA Joint Action 2 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. Mar 2015 © EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 2 EUnetHTA JA2 Ramucirumab for advanced gastric or gastro-oesophageal junction adenocarcinoma WP5 DOCUMENT HISTORY Version Date Description V1.0 08.12.2014 First draft. V1.1 23.01.2015 Input from dedicated reviewers has been processed. V1.2 09.02.2015 Input from medical editor has been processed. V1.3 06.03.2015 Input from WP5/Marketing Authorisation Holder review has been processed. V1.4 20.03.2015 Final technical editing and layout PILOT TEAM Author(s) Norwegian Knowledge Centre for Health Services, Norway Co-Author(s) Agency for Quality and Accreditation in Health Care and Social Welfare, Croatia Dedicated 1. Slovak Ministry of Health, Slovakia Reviewer(s) 2. FIMEA, Finland 3. GYMSZI, Hungary 4. A.Gemelli Teaching Hospital, Italy 5. HAS, France Disclaimer: EUnetHTA Joint Action 2 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. Mar 2015 © EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 3 EUnetHTA JA2 Ramucirumab for advanced gastric or gastro-oesophageal junction adenocarcinoma WP5 CONSULTATION OF THE DRAFT RAPID ASSESSMENT The following WP5 Strand A members have HAS, France provided comments during WP5 consultation [v 1.4] FIMEA, Finland Ministry of Health, Slovakia Scottish Medicine Consortium, Scotland Ministry of Energy and Health, Malta Ministry of Health, Czech Republic AETSA, Spain ZIN, The Netherlands AIFA, Italy Manufacturer/ Marketing Authorisation Holder Eli Lilly and Company Ltd., United Kingdom CONFLICT OF INTEREST All authors and reviewers involved in the production of this pilot assessment have declared they have no conflicts of interest in relation to the technology assessed according to the EUnetHTA conflicts of interest (COI) statement form. Mar 2015 © EUnetHTA, 2015. Reproduction is authorised provided EUnetHTA is explicitly acknowledged 4 EUnetHTA JA2 Ramucirumab for advanced gastric or gastro-oesophageal junction adenocarcinoma WP5 TABLE OF CONTENTS SUMMARY OF RELATIVE EFFECTIVENESS OF RAMUCIRUMAB ...................................................... 9 SCOPE .................................................................................................................................................... 9 INTRODUCTION ........................................................................................................................................ 9 METHODS.............................................................................................................................................. 10 RESULTS ............................................................................................................................................... 10 DISCUSSION .......................................................................................................................................... 16 CONCLUSION ......................................................................................................................................... 17 LIST OF ABBREVIATIONS..................................................................................................................... 18 1 SCOPE .................................................................................................................................................. 20 2 METHODS AND EVIDENCE INCLUDED............................................................................................ 22 2.1. PILOT TEAM .................................................................................................................................. 22 2.2. IDENTIFICATION OF EVIDENCE ........................................................................................................ 22 2.3. QUALITY RATING OF STUDIES ......................................................................................................... 23 2.4. DESCRIPTION OF THE EVIDENCE USED............................................................................................ 24 2.5. DEVIATIONS FROM PROJECT PLAN .................................................................................................. 25 3 DESCRIPTION AND TECHNICAL CHARACTERISTICS OF THE TECHNOLOGY......................... 26 3.1. RESEARCH QUESTIONS.................................................................................................................. 26 3.2. RESULTS ...................................................................................................................................... 26 3.3. DISCUSSION ................................................................................................................................. 34 4 HEALTH PROBLEM AND CURRENT USE OF THE TECHNOLOGY ............................................... 36 4.1. RESEARCH QUESTIONS .................................................................................................................. 36 4.2. RESULTS ...................................................................................................................................... 36 4.3. DISCUSSION ................................................................................................................................. 40 5 CLINICAL EFFECTIVENESS.............................................................................................................. 41 5.1. RESEARCH QUESTIONS.................................................................................................................. 41 5.2. RESULTS ...................................................................................................................................... 41 5.3. DISCUSSION ................................................................................................................................. 50 6 SAFETY...............................................................................................................................................
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