Valeurs seuils pour le rapport coût-efficacité en soins de santé - KCE

54 ICER Thresholds KCE Reports 100
3.6.3.3 Summary
As implants are often presented for reimbursement in early stages of use, feasibility to
find and use scientific (clinical and economic) information is seen as a major problem.
Moreover the available studies are not always considered relevant, especially if they
come from large organisations or centres of excellence.
The deliberation and decision making process is to a large extent negotiated and expert
opinion based. The role of the staff members of the NIHDI is less extensive than in the
DRC. The preliminary work is done by the working groups, specialised in specific
domains (e.g. cardiovascular implants, orthopaedic implants etc). The working groups
prepare an advice, which is afterwards discussed in the plenary TCI meetings. Advice
can be typified as sometimes supported by available (economic) studies, rather than
systematically based on CEA or economic evaluations. ICERs are not used in the
decision making process.
Decision makers focus mainly on the available budget. These budgetary constraints form
the framework within which decisions on reimbursement are taken. The procedural
particularity of the decision making process of the committee is that budgets have to be
set and prepared almost one year in advance of the following working year. A budget
has to be reserved for the following year, but estimations of the budget needed are not
always accurate, sometimes leading to specific problems.
In the answers of the committee members it became clear that cost issues (in terms of
reimbursement) and cost saving issues are considered more than cost-effectiveness
issues. Costs are not always estimated or calculated, they are approached rather
intuitively and experience-based. They stressed that it is often rather obvious to
demonstrate the added value of a product.
Besides this economic element it is stressed that quality of life (not expressed as a
QALY) is a relevant criterion to steer the decision making process.
One of the members of the committee explicitly refers to the difference between a
theoretical and a political ratio in reimbursement decision making processes. The
difference implies that other criteria than clinical effectiveness or cost effectiveness have
to be considered. Cost effectiveness analysis can be of value but cannot be considered
as the sole criterion to base reimbursement decisions upon for implants. Moreover, it is
mentioned that the committee also has to consider other interests and has to work in a
context of societal and media pressure.
The ways in which the two selected committees operate illustrate the growing
awareness of the potential relevance of clinical evidence and economic evaluation
studies. However, factors described in decision making literature are equally affecting
the decision making process. Efforts are made to “rationalise” the decision making
process and substantiate demands for reimbursement with scientific evidence. It helps
to make the decision making criteria more transparent. But it also has to be stressed
that the decision making process remains an interactive deliberation process, which is
certainly not to be reduced to the technocratic rational application of scientific (clinical
and economic) findings: decisions on reimbursement are negotiated and can only be
understood taking into account circumstantial factors.
The DRC is clearly going through a learning curve in the use of cost-effectiveness
knowledge in their decision making process. Clinical effectiveness and cost effectiveness
(including ICERs) are becoming criteria to be documented by the firms and are actively
considered, be it with the necessary critical attitude. It is stressed that decisions on
reimbursement are affected by a lot more criteria and by the nature of the decision
making process.