Optimalisatie van de werkingsprocessen van het Bijzonder ... - KCE

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84 Special Solidarity Fund KCE Reports 133 7.5.4 Early access to new drugs In all countries studied as well as in Belgium a system authorizing new drugs limits the provision and the reimbursement of new drugs. In Belgium registration and authorization of drugs is handled by the Federal Agency for drugs and Health products (FAGG – AFMPS). In Spain as well as in France and the Netherlands similar agencies exist. These agencies have a role on regulating access to drugs and devices. In France as well as in Spain early access to new or innovative drugs can be asked for by medical specialists (for individual use) or by pharmaceutical companies (for use by group of patients). In France Authorizations for temporary use are granted by the AFSSAPS. Drugs used at hospital level are integrated in the hospital budget. These budgets are complemented if the hospitals treat patients that need expensive (or orphan) drugs. Drugs not classified for hospital use only and for outpatients are reimbursed at 100% by health care insurance on the basis on of their transfer price (prix de cession). This price comprises the purchase price (based on price convention between the hospital and the pharmaceutical laboratory) + lump sum margin for the costs of administration and distribution by the hospital + VAT. In Spain the AEMPS decides on the pre-acceptance stage, off label use and the use of foreign drugs (at individual patient level and for homogeneous groups). In Belgium early access to drugs is possible via the SSF (patient initiative). Early access is also possible within the framework of compassionate use (for drugs without MA in Belgium) or medical need programs (for drugs with an MA in Belgium for a given indication, but used for another indication). In contrast with the early access program of France that is financed by public means, these programs are setup and paid by the pharmaceutical company, and the medicines are provided for free.
KCE Reports 133 Special Solidarity Fund 85 8 DISCUSSION AND CONCLUSIONS The SSF was introduced in 1990 as an experiment, aiming at the creation of a safety net preventing people giving up high-cost, yet medically necessary care not reimbursed by the compulsory health insurance. A limitative set of objective -though susceptible to interpretation - eligibility criteria was defined by law. The action field of the SSF has gradually been broadened. Today, the question arises if the SSF meets the objectives that were initially aimed at and more particularly, if there are any unmet needs within the existing SSF framework as defined by law. This question, being part of the original approach of the project, has been abandoned because of methodological reasons. Indeed, it was impossible to identify and quantify people that theoretically meet the SSF reimbursement criteria but did not take up this opportunity. The aim of this study was to make an overall evaluation of the conceptual and procedural functioning of the SSF and to formulate suggestions for the optimization of these processes. In this section we give an overview of the answers to the research questions. When drawing up conclusions, it is important to take the methodological limitations into account. The information on the organization of the SSF, its procedures and activities was obtained by a quantitative as well as a qualitative approach. Interviews were performed with a selection of employees of the NIHDI, with members of the College of medical directors and with the leading medical officer of the SSF. The most important limitations of this approach are that all interviewed persons are directly involved in the functioning of the SSF. On the other hand, a sample of the administrative data from the SSF database was analyzed. It does not constitute a random sample because solely the data of the patients who consented are included. Furthermore the database maintained at the SSF, containing the registration of the details of each application and decision, seems to be mainly targeted for operational use: to organize and register the day to day work flow and for the annual report. From this point of view, quite a lot of information on the applications and decisions is registered. However, from a scientific analysis point of view, the available information is registered in often insufficient detail or in a non-standardized way, precluding more in depth statistical analyses. The evaluation of the functioning of the SSF focuses on the (interpretation of) the eligibility criteria for the reimbursement of costs, the clarity of these criteria for all parties involved, the information channels through which the stakeholders got to know the SSF, the appreciation of the applicable procedures and the decision-making process. Two methodological approaches were used to address these questions. On one hand qualitative surveys were performed to obtain a global overview of the perception of a sample of prescribing doctors, the social services and patients’ associations. An important limitation is that solely stakeholders with a minimum experience with the SSF were interviewed and that only patients having introduced a file to the SSF were included. It is methodologically not feasible to isolate patients (or prescribing physicians) whose medical costs are potentially eligible for reimbursement by the SSF but did not introduce an application. Indeed, since the application field of the SSF is mainly determined by rare diseases or indication, there is little chance to find those patients (or prescribing physicians) in a random sample. On the prescriber side, solely physicians who consented to be interviewed were contacted. Interviews regarding specific topics were conducted with the umbrella organization Pharma.be. Moreover representatives of the pharmaceutical industry, who are also member of the orphan drug working group, were interviewed. They were selected according to their familiarity with the SSF. The international part of the study aimed to find comparable systems to the SSF in France, the Netherlands and Spain. Different information sources were searched. Additionally, a selection of typical SSF cases was used as a way to describe how they are handled in the studied countries.
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