Predictors for reimbursement of oncology drugs in Belgium between 2002 and 2013

Abstract

Background: Price setting and reimbursement decisions regarding drugs are competence of individual member states in Europe. These decisions involve important trade-offs between social, ethical, clinical and economic criteria. The aim of this study was to investigate the relative importance of criteria for reimbursement of oncology drugs in Belgium. Methods: Reimbursement dossiers on oncology drugs for which reimbursement was applied between 2002 and 2013 were consulted. Multivariate logistic regression was performed. Results: Results showed that clinical evidence and presence of alternative treatments have a significant impact on the reimbursement decisions. Conclusions: Evidence-based medicine still plays a role in Belgian reimbursement decision-making. In order to allow transition towards value-based medicine and avoid spending money on products with limited incremental benefit, therapeutic need at patient level need to be taken into account.

Keywords:

• Belgium
• health economics
• health technology assessment
• oncology
• reimbursement

Financial & competing interests disclosure

Research was funded by a Ph.D. grant of the Agency for Innovation by Science and Technology (IWT) and a research grant of the Research Foundation Flanders (FWO). Funding sources were not involved in any design of the study, collection, analysis or interpretation of data. K De Nys is the chair of The Commission of Reimbursement of Medicines (CRM); however, only formulates personal opinion in this paper. M Casteels is former chair of the CRM and currently a member of the Scientific Advice Working Party (SAWP) at the European Medicines Agency (EMA) and also only presents personal opinion in this paper. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Key issues

• In Belgium, drug reimbursement applications are subjected to EBM principles but the relative importance of different criteria is not made explicit.

• Decision making about reimbursement of oncology drugs involves hard trade-offs between social, ethical and economic criteria.

• Between 2002 and 2013, The Commission of Reimbursement of Medicines in Belgium provided a positive advice for reimbursement of oncology drugs to the Minister of Health and Social Affairs in 68% of the applications.

• Drugs with added therapeutic value received less positive advice than drugs without added therapeutic value, which may be related to the high budgetary impact of drugs with added therapeutic value.

• Orphan drug status was not influencing the reimbursement advice, unless lower budgetary impact compared with non-orphan oncology drugs with added therapeutic value.

• The presence of an RCT is a positive predictor for reimbursement, regardless of the relevance of the comparator or end points used in the study.

• The existence of alternative products can generate benefits in terms of health or money and positively influences reimbursement advice.

• Between 2002 and 2013, reimbursement was driven by EBM principles and budgetary objectives. The role of the value of the drugs for patients is less clear, although it is likely to require more attention in the future.