• A typology-based decisional framework to support market access and reimbursement decisions for personalised medicines

      Govaerts, Laurenz; Geldof, Tine; Simoens, Steven; Huys, Isabelle (Value in Health. The Journal of the International Society for Pharmacoeconomics and Outcomes Research, 2017)
      New co-development approaches in personalized medicine challenge current decisional frameworks of health-technology access and reimbursement procedures. We aim to conceptualize an efficient typology-based decisional framework which takes into account the development and market access synchronism between therapeutic (Tx) and diagnostic (Dx) components of personalized medicines.
    • A typology-based decisional framework to support market access and reimbursement decisions for personalized medicines

      Govaerts, Laurenz; Geldof, Tine; Simoens, Steven; Huys, Isabelle; Van Dyck, Walter (2017)
    • Access decision-making in the Belgian Commission for reimbursement of medicines 2010-2017: Investigating the readiness for value-based pricing

      Van Dyck, Walter; Schoonaert, Lies; Geldof, Tine; Govaerts, Laurenz (2018)
      To balance the societal need for affordability of medicines with the industrial need for sustained innovation, the present pharmaceutical technology supply-driven system needs to become a societal demand-driven system. Value-based pricing is considered to be a key component of such a system, next to the conditional dialogue between payer and industry we proposed in previous work (Van Dyck, De Grève et al. 2016) in which it should be embedded. To find out how far Belgian pharmaceutical healthcare-related decision-making has evolved within this paradigm, we empirically investigated the access and reimbursement decision-making of the Belgian Commission for Reimbursement of Medicines (CRM) for the period 2010 – 2017. We combined this investigation with previous work in a meta-analysis in order to have the most complete picture possible of the present factors influencing decision-making in the Belgian system.
    • A comparison of in vitro diagnostic HTA practices in western European countries for inclusion into the benefit basket

      Govaerts, Laurenz; Van Dijck, Walter (2019)
      As the field of health technology assessments pushes towards increasing harmonization and joint assessments, a crucial first step of reaching said goal is the identification of varying practices. Our research highlights these varying HTA practices in western European countries for in vitro diagnostics.
    • Evaluation of precision medicine assessment reports of the Belgian healthcare payer to inform reimbursement decisions

      Govaerts, Laurenz; Waeytens, Anouk; Van Dyck, Walter; Simoens, Steven; Huys, Isabelle (International Journal of Technology Assessment in Health Care, 2020)
      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.
    • Shedding light on reimbursement policies of companion diagnostics in European countries

      Govaerts, Laurenz; Simoens, Steven; Van Dyck, Walter; Huys, Isabelle (Value in Health, 2020)
      Ensuring access to precision medicine has been an issue because in some European countries, desynchronized reimbursement decision-making occurs between the medicine and the companion diagnostic (CDx). This has resulted in cases in which precision medicine is reimbursed but not the CDx. In overcoming this issue, an alignment of the decision-making process for reimbursement between the 2 entities should be considered. As pharmaceutical reimbursement procedures are meticulously covered in the literature, we set out to systematically map in vitro diagnostic (IVD) reimbursement procedures and identify policies for aligning these procedures with the pharmaceutical reimbursement procedures.
    • A systematic review of the value assessment frameworks used within health technology assessment of Omics technologies and their actual adoption from HTA agencies

      Hoxhaj, Ilda; Govaerts, Laurenz; Simoens, Steven; Van Dyck, Walter; Huys, Isabelle; Gutiérrez-Ibarluzea, Iñaki; Boccia, Stefania (International Journal of Environmental Research and Public Health, 2020)
      Background: Omics technologies, enabling the measurements of genes (genomics), mRNA (transcriptomics), proteins (proteomics) and metabolites (metabolomics), are valuable tools for personalized decision-making. We aimed to identify the existing value assessment frameworks used by health technology assessment (HTA) doers for the evaluation of omics technologies through a systematic review. Methods: PubMed, Scopus, Embase and Web of Science databases were searched to retrieve potential eligible articles published until 31 May 2020 in English. Additionally, through a desk research in HTA agencies' repositories, we retrieved the published reports on the practical use of these frameworks. Results: Twenty-three articles were included in the systematic review. Twenty-two frameworks, which addressed genetic and/or genomic technologies, were described. Most of them derived from the ACCE framework and evaluated the domains of analytical validity, clinical validity and clinical utility. We retrieved forty-five reports, which mainly addressed the commercial transcriptomic prognostics and next generation sequencing, and evaluated clinical effectiveness, economic aspects, and description and technical characteristics. Conclusions: A value assessment framework for the HTA evaluation of omics technologies is not standardized and accepted, yet. Our work reports that the most evaluated domains are analytical validity, clinical validity and clinical utility and economic aspects.