PHP126 - A Comparative Study of the Role of Disease Severity in Drug Reimbursement Decision Making in Belgium, France, the Netherlands and Sweden

Abstract

Considerations beyond (cost-) effectiveness are increasingly important in reimbursement decision-making. We investigated the importance of disease severity relatively to other decision criteria in drug reimbursement decision-making in four European countries. The importance of disease severity and its operationalization was assessed in Belgium, France, The Netherlands and Sweden. We investigated scientific literature, policy documents, reimbursement reports, and conducted three interviews in each country (four in The Netherlands) with policymakers involved in drug reimbursement. All interviewees acknowledged that disease severity is, especially in case of high severity, an important criterion while considering a drug’s (cost-) effectiveness. However, its relative importance compared to other decision criteria remains implicit in the decision-making process. Although rarity of the disease is not a criterion as such, interviewees indicated difficulties in separating rarity from severity and the availability of alternative treatments. Only Belgium and France explicitly show societal willingness to pay by using reimbursement levels depending on the severity of the disease. In Sweden, ‘need and solidarity’ is one of the three prioritizing principles. The Netherlands is the only country that quantitatively operationalized disease severity using the proportional shortfall method and suggesting a cost-effectiveness threshold range depending on disease severity (which was never formalised by the minister). Although interviewees acknowledged that quantitative information, besides a qualitative description of the disease, may provide additional decision information, none of them considered such information to be of decisive importance. Disease severity is, especially in case of high severity, an important decision criterion in all four countries. However, all countries seem to struggle in making its actual role explicit. The operationalization differs across countries. While Belgium and France are most explicit by using the severity of the disease in setting reimbursement levels, all countries could improve transparency of its actual importance relatively to other decision criteria.