OBJECTIVES: In Belgium the decision to reimburse and the level of reimbursement is officially based on clinical effectiveness, (added) therapeutic value, price of the drug, budget impact and cost-effectiveness. We empirically investigated which parameters are taken into account in 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.

METHODS: All completed class 1 requests, for which a reimbursement decision was made, were retrieved from the CRM database and contain 74 applications of the middle of 2010 to the middle of 2017. Due to a high level of missing data, classical regression analysis did not provide sufficient results. Through probabilistic analysis the probability of obtaining a positive decision, a managed entry agreement (MEA) or a negative decision was calculated given that the drug has a certain value for budget impact, ICER, clinical evidence and added therapeutic value.

RESULTS: We concur with previous studies that clinical evidence on the novel therapy moderately impacts the access decision, but added therapeutic value cannot be shown to have an influence on the access decision. We were able to show that now, for class 1 candidates an implicit threshold ICER of €31.5 K/QALY, is uniformly used across all disease burden domains and that budget impact levels below €3.5M enhance the probability for a positive decision and MEAs.

CONCLUSIONS: The Belgian access and reimbursement system does take into account both cost-effectiveness (although implicitly) and budget impact as a basis for decision-making, which is in line with academic thinking that cost-effectiveness analysis and budget impact analysis should be seen in conjunction to manage the affordability challenge.