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dc.contributor.authorGovaerts, Laurenz
dc.contributor.authorWaeytens, Anouk
dc.contributor.authorVan Dyck, Walter
dc.contributor.authorSimoens, Steven
dc.contributor.authorHuys, Isabelle
dc.date.accessioned2020-10-16T12:25:04Z
dc.date.available2020-10-16T12:25:04Z
dc.date.issued2020en_US
dc.identifier.issn0266-4623
dc.identifier.doi10.1017/S0266462320000604
dc.identifier.urihttp://hdl.handle.net/20.500.12127/6576
dc.description.abstractIntroduction. Precision medicines rely on companion diagnostics to identify patient subgroups eligible for receiving the pharmaceutical product. Until recently, the Belgian public health payer, RIZIV-INAMI, assessed precision medicines and companion diagnostics separately for reimbursement decisions. As both components are considered co-dependent technologies, their assessment should be conducted jointly from a health technology assessment (HTA) perspective. As of July 2019, a novel procedure was implemented accommodating for this joint assessment practice. The aim of this research was to formulate recommendations to improve the assessment in the novel procedure. Methods. This study evaluated the precision medicine assessment reports of RIZIV-INAMI of the last 5 years under the former assessment procedure. The HTA framework for co-dependent technologies developed by Merlin et al. for the Australian healthcare system was used as a reference standard in this evaluation. Criteria were scored as either present or not present. Results. Thirteen assessment reports were evaluated. Varying scores between reports were obtained for the domain establishing the co-dependent relationship between diagnostic and pharmaceutical. Domains evaluating the clinical utility of the biomarker and the cost-effectiveness performed poorly, whereas the budget impact and the transfer of trial data to the local setting performed well. Recommendations. Based on these results we recommend three amendments for the novel procedure. (i) The implementation of the linked evidence approach when direct evidence of clinical utility is not present, (ii) incorporation of a bias assessment tool, and (iii) further specify guidelines for submission and assessment to decrease the variability of reported evidence between assessment reports.en_US
dc.language.isoenen_US
dc.publisherCambridge University Pressen_US
dc.subjectPrecision Medicineen_US
dc.subjectCompanion Diagnosticsen_US
dc.subjectReimbursementen_US
dc.titleEvaluation of precision medicine assessment reports of the Belgian healthcare payer to inform reimbursement decisionsen_US
dc.identifier.journalInternational Journal of Technology Assessment in Health Careen_US
dc.source.volume36en_US
dc.source.issue4en_US
dc.source.beginpage410en_US
dc.source.endpage417en_US
dc.contributor.departmentDepartment of Pharmaceutical and Pharmacological Sciences, KU Leuven, Herestraat 49, Box 521, Leuven, Belgiumen_US
dc.contributor.departmentNational Institute for Health and Disability Insurance (RIZIV-INAMI), Brussels, Belgiumen_US
dc.identifier.eissn1471-6348
vlerick.knowledgedomainOperations & Supply Chain Managementen_US
vlerick.knowledgedomainSpecial Industries : Healthcare Managementen_US
vlerick.typearticleJournal article with impact factoren_US
vlerick.vlerickdepartmentTOMen_US
dc.identifier.vperid219312en_US
dc.identifier.vperid31183en_US


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