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

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88 Special Solidarity Fund KCE Reports 133 Although there is no strict criterion for the delegation to one member of the SSF, the data analysis on the SSF sample reveals that decisions on renewals are to an increasing extent delegated to the leading medical officer of the SSF. 8.3.3 Administrative burden The administrative burden is reported to be primarily situated at the level of the social service of the hospital. There is consensus between the interviewees that the administrative burden is heavy. The following examples illustrate this statement: • Administrative formalities for renewals although it is clear the patient will need the treatment for a long period; • Providing the same information for comparable cases the SSF already possesses resulting in duplication of information (and workload); • Provision of information which is already at the disposal of the SSF as part of the NIHDI (financial costs of material, drugs, …); • Obligation to provide the hospital’s invoice for the material or the drug when entering a SSF file. This is a heavy administrative workload and can easily be postponed till after a positive decision on the application. For the financial department the search of invoices (invoice to the hospital) is rather complicated since drugs and medical devices are not bought piece by piece and invoices contain various products; • Non acceptance of an electronic signature on the medical file entered by the prescribing medical doctor. At patient level the provision of the declaration on honor that all other legal reimbursement sources in Belgium as well as abroad, or reimbursement by private insurance have been exhausted can cause problems. Our research showed that this is a purely administrative item and that the SSF is not able to check the existence of possible individual rights to reimbursement or if a patient has already (eventually partially) been compensated through other channels. However it can cause a delay on the decision if it is missing. It might result in a non reimbursement if the patient died in the meantime. 8.3.4 Reporting and transparency For decisions taken by ‘one member of the College’ only negative decisions are also signed by a second member of the college (medical director of the sickness fund of the patient). No further reporting is being organized. For delegated decisions to the local sickness funds, the only reporting is financial via the NIHDI. All stakeholders clearly stress the unclearness of (the interpretation of) several criteria. The motivation of the decisions is perceived as administrative since the legal criteria on which the decision was based are mentioned. Currently legislation provides that an annual report has to be presented to the Verzekeringscomité/Comité de l'assurance and the Algemene Raad/Conseil Général. There is no legal obligation to make these annual reports publicly available. 8.3.5 Stakeholder involvement The SSF is perceived as very distant and totally absent from the healthcare scene. No contacts exist with patient groups, the medical profession or the hospital services. Such contacts are reported to be avoided and even refused. Dissemination of the decision to the respective social service the patient contacted or the treating physicians is absent. Yet, this information is conceived as necessary by these stakeholders. Individual decisions on applications are not transferred to the providers of drugs or devices subject to the SSF application (delivering medical companies). As such this is acceptable and obvious because of privacy issues. In principle it is possible to contact the SSF; the phone number and the email address are mentioned at the NIHDI website.
KCE Reports 133 Special Solidarity Fund 89 8.3.6 Sufficient expertise at SSF level The interviewed physicians in particular question if the expertise at the level of the College of medical directors is sufficient. The variety and rareness of the diseases/indications makes the assessment by the same panel of “experts” extremely difficult. One cannot expect them to have all necessary knowledge on all cases submitted. Although the possibility of consulting external experts by the SSF College exists, until today this is rarely used. There is however representation of the Drug Reimbursement Commission in the College of medical directors. The SSF leading medical officer stressed that the quality of prescriptions, the medical files and the evidence is often insufficient. This hampers a proper assessment of the case at stake by the members of the College. 8.3.7 Appeal If the patient disagrees with the decisions of the SSF, he/she can launch an appeal to the competent labour court. Patient organisations state that most patients are not aware of the appeal procedure or judge it as heavy. The judgments of the labour court are not systematically monitored by the SSF and do not serve as guidelines for future decisions on individual cases. Similar cases are not reconsidered or reviewed by the SSF. This is not so surprising since there is no continuity and uniformity in the interpretation of some of the eligibility criteria by the courts. A fundamental criticism is that the expertise at court level is often not sufficient to judge on the mostly very specific medical issues. One could envisage installing a proper appeal procedure at SSF or NIHDI level, although legally all disputes regarding the legislation on the compulsory health care insurance fall within the competence of the labour courts. Installing such an appeal procedure does not completely solve the issue of inadequate expertise because of the variety of medical domains. External experts could however be implied. 8.4 EXPLORATION OF (COMPARABLE) SAFETY NETS IN A SELECTION OF FOREIGN COUNTRIES No mirror system comparable to the SSF was found in the studied countries. There are however interesting mechanisms aiming at the management of rare diseases and the early access to new drugs. A comparison of the reimbursement of a selection of products reimbursed by the SSF reveals that some of these products are not reimbursed in the studies countries. 8.4.1 Early access system to new drugs The notion of “new drug” is considered as new for a particular indication which implies that off label use is also considered. Early access to new drugs is most often during the third phase of the clinical trial and when its safety and efficacy are strongly assumed. France and Spain have implemented an early access system. In France, temporary authorisations (ATU) allows the use of drugs, outside of the framework of clinical trials, without Marketing authorisation (MA) in France, whether they benefit or not from a MA abroad. Solely drugs that are used for the treatment of serious or rare diseases, for which there is no other treatment available and cost-benefit analysis of the treatment was conducted, with a positive result are eligible for ATU. Off-label use of drugs is not eligible for reimbursement. The authorisation can be granted by AFSSAPS for use at individual patient level (at the request of the prescribing physician) or homogeneous group (cohort) level (at the request of the pharmaceutical firm) in a very short time laps. For cohort ATU a temporary use authorisation must be accompanied by a simultaneous demand for a MA or an intention to file an MA dossier in the near future. Moreover cohort ATU is subordinated to the implementation of a protocol for therapeutic use and information collection. For nominative ATU, the agency notably relies on a dossier on quality, efficacy and safety of the medicinal product supplied by the pharmaceutical company at its request and, if necessary, by the ATU applicant. In France, drugs used at hospital level are integrated in the hospital budget.
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