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Purpose: Centrally authorised medicinal products (CAMPs) in the European Union may offer added therapeutic value (ATV) but may be linked to high prices and limited efficiency. Health technology assessment (HTA) and managed entry schemes (MES) may facilitate the reimbursement decision by providing reliable estimates of the medicinal product’s value and costs and by controlling the remaining uncertainty, respectively. We investigated the impact of HTA criteria and the initiation of a MES on the reimbursement decision of CAMPs in Belgium. Methods: We selected all reimbursement submissions for new centrally authorised medicinal products in the 2010–2015 period. We retrieved data relating to the reimbursement decision, the HTA outcome and the use of a managed entry scheme. Results: The decision of the Minister was available for 115 dossiers, covering 36 (31.3%) orphan medicinal products (OMPs) and 79 ATV products. A MES was used in 41 submissions. A positive reimbursement decision was obtained in 65% of cases. The significant factors affecting the reimbursement decision were the approval of ATV, the medical need if it was considered ‘important or major’ and the use of a managed entry scheme. Price, budget impact and efficiency had no significant impact. Conclusions: Added therapeutic value and high medical need increase the odds for a positive reimbursement decision. No impact could be demonstrated of the cost-related HTA criteria. Cost elements may be biased by the use of a confidential MES. Without a MES, only 53% of the centrally authorised medicinal products, including OMPs, are reimbursed in Belgium., SCOPUS: ar.j, info:eu-repo/semantics/published

The objective of this study was to compare costs data by diagnosis related group (DRG) between Belgium and Switzerland. Our hypotheses were that differences between countries can probably be explained by methodological differences in cost calculations, by differences in medical practices and by differences in cost structures within the two countries.Classifications of DRG used in the two countries differ (AP-DRGs version 1.7 in Switzerland and APR-DRGs version 15.0 in Belgium). The first step of this study was to transform Belgian summaries into Swiss AP-DRGs. Belgian and Swiss data were calculated with a clinical costing methodology (full costing). Belgian and Swiss costs were converted into US$ PPP (purchasing power parity) in order to neutralize differences in purchasing power between countries.The results of this study showed higher costs in Switzerland despite standardization of cost data according to PPP. The difference is not explained by the case-mix index because this was similar for inliers between the two countries. The length of stay (LOS) was also quite similar for inliers between the two countries. The case-mix index was, however, higher for high outliers in Belgium, as reflected in a higher LOS for these patients. Higher costs in Switzerland are thus probably explained mainly by the higher number of agency staff by service in this country or because of differences in medical practices.It is possible to make international comparisons but only if there is standardization of the case-mix between countries and only if comparable accountancy methodologies are used. Harmonization of DRGs groups, nomenclature and accountancy is thus required.

Objectives of this article are to evaluate the possibility to create a CW scale by pathology on the basis of cost data from Belgian hospitals, to compare several methodologies to create this CW scale, and to evaluate the financial impact of a modification of the financing system on hospitals’ income. CW scales were elaborated according to various methodologies in order to isolate the scale allowing the most adequate financing system, i.e. approaching the real costs as much as possible. Twelve scales were created. They vary according to the type of data used, according to DRGs and severities of illness included within the scale, and according to the variable used in order to isolate outliers. For a similar case-mix, Hospitals H2 and H5 would see their financing increased through a prospective system based on the selected CW scale (No. 6). This modification would generate a reduction in financing going from −1 to −9% according to hospitals. The cost database created made it possible to create a CW scale according to a technique which could constitute the first step of a PPS if advantages of a such financing system were established. In the Belgian context, it would be probably judicious to envisage regional databases allowing diversified methodological approaches whose results would be confronted, discussed, and coordinated at the federal level.