Terugbetalingssystemen voor geneesmiddelen ... - Pharma

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22 Drug Reimbursement Systems KCE Reports 147 c) Deliberation-driven and assessment-driven model The two implementation models can be classified as: (1) deliberation-driven models and (2) assessment-driven models. In the deliberation-driven model, the expert committee consists of representatives of all relevant stakeholders. In the assessment-driven model the expert committee mainly consists of academic/scientific and other experts. The latter consults relevant stakeholders on a case-by-case basis. Figure 6 gives a graphic presentation of the relationships between the stakeholders and the expert committee in the two models. Figure 6: Deliberation-driven versus assessment-driven drug reimbursement systems Deliberation-driven model Assessment-driven model Expert committee Expert committee Scientists (medical, health services, other) Patient representatives Health insurers' representatives Pharmaceutical industry's representatives Physicians' representatives Other stakeholders' representatives Pharmacists representatives Medical experts Other stakeholders' representatives Health services experts Physicians' representatives Patients' representatives Pharmacological experts Health insurers' representatives Other scientists HTA agencies Deliberation-driven models, such as in Belgium and Austria, aim to formulate advices which incorporate societal preferences by having all relevant stakeholders represented in the expert committee. Stakeholders are appointed as committee members for a specific period of time and hence involved in the appraisal process of every individual product. As such there is room for discussion about the rationale and reason for each new advice. The crucial and challenging task in this model is to select appropriate representatives, who are reasonable and fair-minded, understand the basic objectives and challenges of drug reimbursement decision making and are willing to look for mutually justifiable decisions. Lobbyists who are insensitive to reasonable and fair argumentation and only defend their personal interest, tend to block the system and should therefore not be appointed as expert members. Assessment-driven models, such as in the Netherlands, Sweden and France, more heavily rely on academic and other scientific experts from different disciplines. These experts should reasonably adopt societal preferences to individual dossiers. This model is generally less subject to the influence of lobbyists during the appraisal phase, although such influence cannot be ruled out. Also in assessment-driven models deliberation with respect to weighing several decision criteria needs to take place. This weighing might be influenced by the public opinion about a specific product, as exposed in the media, and by direct formal or informal contacts between experts and individual patient organisations or industry. 38 It should be noted that the distinction between assessment-driven and deliberationdriven models does not suggest anything about the objectivity and transparency of the process. A deliberation process is per definition never neutral or value-free. Therefore, it is of utmost importance that either committee members use societal preferences independently from their personal preferences or the committee is composed in such a way that societal preferences are represented in a balanced way.
KCE Reports 147 Drug Reimbursement Systems 23 d) Deliberation process within the expert committee Another divergence concerns the rules around the deliberation process, e.g. consensus, quorum of presence, mode of voting. The Netherlands is the only country where members base their advice on consensus. If no consensus is reached, the advice is based on majority voting. In Sweden, France and Austria majority allows to approve an advice (decision). Belgium is unique in that a two-third majority is required to accept or reject an advice. This rule implies that the committee may end up with no advice. In that situation, the final decision-maker, the minister of social affairs receives no guidance for his/her decision from the expert committee and can only rely on the report of his/her representative at the expert committee. e) Discretionary power of the minister of health In all countries, the minister of health is responsible for defining the overall drug reimbursement policy and steering the system. However, divergences were found concerning the minister’s responsibility in final decision-making. In Belgium, the Netherlands and France, the minister is responsible for making the final drug reimbursement decision. But even at that level, differences were found in the level of discretionary power allotted to the minister. In France, the minister rarely deviates from the advice of the expert committee. The only notable exception occurred after a group revision which took place between 1999 and 2001, 835 drugs were no longer deemed to have a sufficient level of medical service rendered (SMR) to justify reimbursement. Facing criticism from the industry and a number of patients and providers, the minister decided not to delist these drugs all at once, but rather to progressively de-list drugs in three waves. In Belgium, the minister is allowed to deviate from the advice for “social or budgetary reasons”, be it within limits specified by law. The limits are that the deviation from the advice can only be based on one or more of the assessment elements which have already been appraised by the expert committee. Deviation from the advice –most often for budgetary reasons– sometimes occurs. In contrast to outpatient drugs, the reimbursement decision for expensive inpatient drugs in the Netherlands is made by the Health Care Authority (NZa). Nevertheless, the minister is not only allowed to deviate from the reimbursement advice for outpatient drugs but also allowed to overrule the reimbursement decision for expensive inpatient drugs. Both deviations rarely occur. Noteworthy is that in Austria and Sweden the minister has neither a decision right nor discretionary power with respect to individual reimbursement decisions. 2.2.2.5 From clinical effectiveness to health technology assessment (HTA) Many European countries use HTA to support coverage and reimbursement decisions. 20 The extent of using HTA differs amongst countries. Sweden and the Netherlands have a long tradition of using HTA to inform health care policy making, amongst others through the research of independent agencies such as iMTA (the Netherlands) and SBU (Sweden). Cost-effectiveness is an explicit drug reimbursement criterion since 2002 and 2005 in Sweden and the Netherlands, respectively. Use of HTA is relatively more recent in Austria, Belgium and France. Since 2000, assessments of costs and health outcomes are used on a regular basis to inform Austrian reimbursement decisions. Moreover in 2006 the independent Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA) was established. Similarly, in 2001 cost-effectiveness was formally introduced as a reimbursement criterion in the Belgian drug reimbursement procedure and in 2004 the Belgian Health Care Knowledge (KCE) was established. While the expert committees have a legal obligation for assessing and appraising drug reimbursement requests, HTA agencies very often work on an ad hoc basis or at the specific request of policy makers. In 2008, the French National Authority for Health (HAS) was encouraged by legislation to consider cost-effectiveness information. The Economic and Public Health specialised Committee (CEESP), a specific advisory committee was set up accordingly.
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