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Evaluation of precision medicine assessment reports of the Belgian healthcare payer to inform reimbursement decisions

Published online by Cambridge University Press:  07 September 2020

Laurenz Govaerts Open the ORCID record for Laurenz Govaerts [Opens in a new window] ,
Anouk Waeytens ,
Walter Van Dyck ,
Steven Simoens  and
Isabelle Huys
Laurenz Govaerts*
Affiliation:
Healthcare Management Centre, Vlerick Business School, Ghent, Belgium Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Herestraat 49, Box 521, Leuven, Belgium
Anouk Waeytens
Affiliation:
National Institute for Health and Disability Insurance (RIZIV-INAMI), Brussels, Belgium
Walter Van Dyck
Affiliation:
Healthcare Management Centre, Vlerick Business School, Ghent, Belgium Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Herestraat 49, Box 521, Leuven, Belgium
Steven Simoens
Affiliation:
Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Herestraat 49, Box 521, Leuven, Belgium
Isabelle Huys
Affiliation:
Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Herestraat 49, Box 521, Leuven, Belgium
*
Author for correspondence: Laurenz Govaerts, E-mail: laurenz.govaerts@kuleuven.be
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Abstract

Introduction

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.

Keywords

Precision medicineCompanion diagnosticsReimbursement
Type
Assessment
Information
International Journal of Technology Assessment in Health Care , Volume 36 , Issue 4 , August 2020 , pp. 410 - 417
Copyright
Copyright © The Author(s), 2020. Published by Cambridge University Press

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