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

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62 Special Solidarity Fund KCE Reports 133 • The use of new drugs as well as prescription of drugs for other indications then those registered, must be easier and integrated in the compulsory health care insurance system. Moreover there is a lack of clear motivation of the SSF decisions. Decisions have to be motivated from a medical point of view and not from a administrative one (as they are now). • The outcome of an SSF application is not predictable. Several respondents (5 directly and 4 indirectly) said they obtained different decisions on similar cases. • Decisions on SSF applications have to be taken by peers. One cannot expect the medical directors to have the knowledge and the expertise on such complicated medical cases and pathologies. Suggestions are: advice from independent experts; second opinion, post factum review of the medical files by expert, post factum assessment of the effectiveness of the treatment. • The SSF has to have more confidence in the medical doctors that prescribe treatments for rare diseases or patients with very special specific medical conditions. Their expertise must be valued. One should start from an acceptance of the treatments they prescribe, not a refusal. • When a negative decision (actual procedure) is envisaged, the respondents expect to be contacted in advance as to be able to add information or clarify the case. • The SSF is totally unknown to the medical profession. Only one respondent said he (once) had a personal contact at SSF level. The SSF is a black box, hidden in the woods. • The procedure for appealing a decision taken by the SSF is not adequate, an internal procedure has to be foreseen. 6.5 THE PHARMACEUTICAL INDUSTRY To have the opinion of the pharmaceutical industry on the functioning of the SSF, we contacted the umbrella Belgian organisation Pharma.be. The perceptions of Pharma.be can be found in annex 9.13. Furthermore, representatives of four pharmaceutical companies, indicated by Pharma.be as the most familiar with the SSF expressed their opinion. The overall results can be found in annex 9.13. 6.5.1 Positive elements on the functioning of the SSF • The SSF is seen as a system that provides solutions to patients for high medical expenses that are not covered by the compulsory health care insurance system. 6.5.2 Negative elements on the functioning of the SSF / suggestions for improvement • According to Pharma.be, there is a need to have a specific system for “early access” to new drugs that have already obtained the EMEA market authorisation but where there is no decision yet at Belgian level for reimbursement of the drug. If market authorisation has been obtained, the pharmaceutical industry finds it is the responsibility of the compulsory health care insurance system to cover the costs. • According to the interrogated pharmaceutical companies, the time that is needed for acceptance of new drugs (after EMEA registration) into the Belgian compulsory health care insurance system has to be shortened.
KCE Reports 133 Special Solidarity Fund 63 • Compassionate use and medical need programs are not seen as a structural solution for access to medication that is not accepted yet in Belgium but that (in the case of medical need programs) obtained the EMEA market authorisation. For smaller pharmaceutical companies it is not obvious to bear the cost of compassionate use. Compassionate use is not seen as a structural solution for off label use of medication. • The interviewed pharmaceutical companies state that for drugs that are used for rare indications, it is not obvious to ask for EMEA market authorisation. The cost for the studies is too high in perspective of the number of cases concerned. In some cases scientific studies just cannot be performed since the patient groups are too small. • Two alternative systems are suggested by the pharmaceutical companies. On the one hand, a risk sharing system where the public health care insurance system will only fund the costs of the medication if the patient reacts favourably to the treatment can be envisaged. On the other hand stopping rules where reimbursement stops when a patient does not respond to the treatment could be an alternative. • Transparency of the criteria used by the SSF is perceived as poor. • On the procedural level, the time to get a decision from the SSF is judged as unacceptably long, The internal procedures of the SSF as well as the preliminary steps at sickness fund level are perceived as not clear. • The administrative burden for the prescribing medical doctor is judged as too high leading to cases where no application is introduced although theoretically the SSF could intervene. • According to the pharmaceutical companies, decisions at the SSF are taken without having the expertise that is needed to do it adequately. The advice of the NIHDI Drug Reimbursement Commission is no alternative. • The pharmaceutical companies are not at all involved in the SSF procedures. They have no knowledge or control at all on the introduction of an SSF application. • The administrative follow up of the invoices for the medication by the hospitals is judged as very time consuming. In some cases the total amount of these invoices that are waiting for payment can be very important. • The pharmaceutical companies ask to have a more transparent procedure where the SSF would keep them informed on the decision and the payment procedure. Such notification can be installed in full respect of the patients’ privacy by making it completely anonymous.
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Optimalisatie van de werkingsprocessen van het Bijzonder ... - KCE

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