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Mammaprint® Test for Personalised Management of Adjuvant Chemotherapy Decisions in Early Breast Cancer a Rapid Assessment

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Mammaprint® Test for Personalised Management of Adjuvant Chemotherapy Decisions in Early Breast Cancer a Rapid Assessment KCE REPORT 298 MAMMAPRINT® TEST FOR PERSONALISED MANAGEMENT OF ADJUVANT CHEMOTHERAPY DECISIONS IN EARLY BREAST CANCER A RAPID ASSESSMENT 2018 www.kce.fgov.be KCE REPORT 298 HEALTH TECHNOLOGY ASSESSMENT MAMMAPRINT® TEST FOR PERSONALISED MANAGEMENT OF ADJUVANT CHEMOTHERAPY DECISIONS IN EARLY BREAST CANCER A RAPID ASSESSMENT LORENA SAN MIGUEL, CECILE DUBOIS, SOPHIE GERKENS, JILLIAN HARRISON, FRANK HULSTAERT 2018 www.kce.fgov.be COLOPHON Title: MammaPrint® test for personalised management of adjuvant chemotherapy decisions in early breast cancer Authors: Lorena San Miguel (KCE), Cécile Dubois (KCE), Sophie Gerkens (KCE), Jillian Harrison (KCE), Frank Hulstaert (KCE) Project coordinator: Nathalie Swartenbroeckx (KCE) Reviewers: Pascale Jonckheer (KCE), Mélanie Lefevre (KCE) External experts: Pino G. Cusumano (Kankercentrum – Centre du Cancer; WIV-ISP), Giuseppe Floris (UZ Leuven), Joris Mattheijssens (Belgian Cancer Registry), Patrick Neven (UZ Leuven), Roberto Salgado (Jules Bordet Institute), Christos Sotiriou (Jules Bordet Institute), Nancy Van Damme (Belgian Cancer Registry), Hans Wildiers (UZ Leuven) External validators: Nynke Dragt (ZiN), Mirjana Huic (Agency for Quality and Accreditation in Health Care and Social Welfare Croatia), Walter Van Dyck (Vlerick business school – Healthcare MGMT centre) Acknowledgements: Nancy Van Damme (Stichting Kankerregister) Reported interests: ‘All experts and stakeholders consulted within this report were selected because of their involvement in the topic of Mammaprint. Therefore, by definition, each of them might have a certain degree of conflict of interest to the main topic of this report’ Participation in scientific or experimental research as an initiator, principal investigator or researcher: Walter Van Dyck (Horizon scanning policy research unconditional grant Roche, MSD) Payments to speak, training remuneration, subsidised travel or payment for participation at a conference: Walter Van Dyck (Roche Switzerland – HTA: conference Rome 2017 on machine learning in HTA) Other possible interests that could lead to a potential or actual conflict of interest: Pino G. Cusumano (Member companion diagnostic (CD) INAMI – RIZIV) Layout: Ine Verhulst, Joyce Grijseels Disclaimer: The external experts were consulted about a (preliminary) version of the scientific report. Their comments were discussed during meetings. They did not co-author the scientific report and did not necessarily agree with its content. Subsequently, a (final) version was submitted to the validators. The validation of the report results from a consensus or a voting process between the validators. The validators did not co-author the scientific report and did not necessarily all three agree with its content. Finally, this report has been approved by common assent by the Executive Board. Only the KCE is responsible for errors or omissions that could persist. The policy recommendations are also under the full responsibility of the KCE. Publication date: 22 januari 2018 Domain: Health Technology Assessment (HTA) MeSH: Breast Neoplasms; Gene Expression Profiling NLM Classification: 870 Language: English Format: Adobe® PDF™ (A4) Legal depot: D/2018/10.273/09 ISSN: 2466-6459 Copyright: KCE reports are published under a “by/nc/nd” Creative Commons Licence http://kce.fgov.be/content/about-copyrights-for-kce-publications. How to refer to this document? San Miguel L, Dubois C, Gerkens S, Harrison J, Hulstaert F. MammaPrint® test for personalised management of adjuvant chemotherapy decisions in early breast cancer. Health Technology Assessment (HTA) Brussels: Belgian Health Care Knowledge Centre (KCE). 2018. KCE Reports 298. D/2018/10.273/09. This document is available on the website of the Belgian Health Care Knowledge Centre. KCE Report 298 MammaPrint® test in adjuvant chemotherapy decisions for early breast cancer patients 1 ■ TABLE OF CONTENTS LIST OF FIGURES ...............................................................................................................................................3 LIST OF TABLES .................................................................................................................................................3 LIST OF ABBREVIATIONS .................................................................................................................................5 ■ SCIENTIFIC REPORT ............................................................................................................................6 1 INTRODUCTION AND SCOPE .............................................................................................................6 2 BREAST CANCER ................................................................................................................................7 2.1 EPIDEMIOLOGY ....................................................................................................................................7 2.2 PROGNOSIS AND TREATMENT ..........................................................................................................7 3 MAMMAPRINT® IN EARLY BREAST CANCER ..................................................................................8 3.1 MAMMAPRINT® .....................................................................................................................................8 3.2 METHODS FOR ASSESSMENT OF CLINICAL UTILITY .....................................................................8 3.3 RESULTS ON THE CLINICAL UTILITY OF MAMMAPRINT® ...............................................................8 4 SYSTEMATIC LITERATURE REVIEW OF ECONOMIC STUDIES ...................................................12 4.1 INTRODUCTION ..................................................................................................................................12 4.2 METHODS ............................................................................................................................................12 4.2.1 Search strategy ......................................................................................................................12 4.2.2 Selection procedure ...............................................................................................................12 4.2.3 Selection criteria .....................................................................................................................12 4.3 OVERVIEW OF ECONOMIC EVALUATIONS .....................................................................................13 4.3.1 Type of economic evaluation .................................................................................................14 4.3.2 Time frame of analyses and discounting ...............................................................................14 4.3.3 Perspective ............................................................................................................................15 4.3.4 Population ..............................................................................................................................15 2 MammaPrint® test in adjuvant chemotherapy decisions for early breast cancer patients KCE Report 298 4.3.5 Comparators ..........................................................................................................................15 4.3.6 Cost and outcome inputs .......................................................................................................15 4.3.7 Modelling ................................................................................................................................16 4.3.8 Results ...................................................................................................................................17 4.3.9 Sensitivity analysis .................................................................................................................22 4.3.10 Conflict of interest ..................................................................................................................22 4.4 DISCUSSION AND CONCLUSIONS ...................................................................................................22 5.2 PATIENTS’ SELECTION ......................................................................................................................25 5.4.2 Characteristics of the subset of patients for the Belgian context ...........................................30 5.4.3 Target population and projection ...........................................................................................32 6 CHEMOTHERAPY USE AND RELATED COSTS IN EARLY BREAST CANCER PATIENTS IN BELGIUM .............................................................................................................................................36 6.1 CHEMOTHERAPY COMBINATIONS ..................................................................................................36 6.2 OTHER NON-PHARMACOLOGICAL CHEMOTHERAPY-RELATED COSTS ...................................37 6.2.1 Chemotherapy administration ................................................................................................37 6.2.2 Blood tests .............................................................................................................................37 6.2.3 Costs of prophylaxis or management of common chemotherapy related adverse events (AEs) ...........................................................................................................................38 6.2.4 Other costs .............................................................................................................................39
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