Terugbetalingssystemen voor geneesmiddelen ... - Pharma

8 Drug Reimbursement Systems KCE Reports 147
Table 1: Elements of the Hutton framework
Elements of the system
1. Policy level Establishment Objectives Implementation Accountability
2. Technology Constitution and Methods and Use of evidence Transparency,
decision level governance
a) Assessment Consultation and
involvement of
stakeholders
processes
Methodology
Evidence-base for
assessment
accountability
Presentation and
communication of
assessment results
b) Decision Who makes the
decision
Decision making
process
Evidence-base and
additional
influences
Content and
documentation of
the decision
c) Outputs and
implementation
Appeal and
dissent
Source: Hutton et al. 2006 40
Implementation
and
communication
Monitoring and
reappraisal
Evidence of the
impact of the
decision
1.3.2 Assessing accountability for reasonableness
The Hutton framework is a descriptive framework and therefore does not assign a
normative value to the structure of a system. The framework can enhance our
understanding of how different policies function in relation to specific requirements,
related to the outcomes of the system as well as to the process of coming to these
outcomes. First, reimbursement systems have clear health system objectives (quality of
care, sustainability and equity), rooted in common societal values (see chapter 2).
However, judging the performance of drug reimbursement systems on the outcomes of
these objectives is difficult. Second, in a democratic system health care policy making
should be a legitimate process for society. In this report, we operationalise legitimacy as
accountability for reasonableness. To assess systems on their strengths and weaknesses
relative to their accountability for reasonableness, we use a theoretical framework
developed by Daniels & Sabin, defining the conditions for achieving legitimate and fair
coverage decisions for new treatments. 41
The central idea behind “accountability for reasonableness” is that, in the absence of
consensus regarding the relevance of ethical principles, priority setting is legitimate if
everyone agrees on a fair priority-setting procedure. 41 In other words, it is recognised
that moral disagreements exist within a community about the ethical principles that
should guide priority setting, but that despite this, consensus might be found about the
fairness of a procedure. When translated to drug reimbursement procedures, this
implies that there should not necessarily be consensus about the weight given to each of
the drug reimbursement criteria (e.g. added therapeutic value, improvement in
applicability as part of the added therapeutic value, severity of disease, budget impact)
but there should be agreement about the fairness of the decision making process and
the relevance of the criteria considered during the process.
According to Daniels and Sabin, a fair and legitimate priority setting procedure satisfies
four conditions:
1. Transparency: the process must be fully transparent about the grounds
for/rationales behind a decision
2. Relevance: the decision must rest on reasons that all stakeholders can accept as
relevant to meeting health needs fairly given the resource constraints
3. Revisability: decisions should be revisable in light of new evidence and arguments
4. Enforcement/regulation: there must be some kind of regulation guaranteeing the
three conditions described above.