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

KCE Reports 133 Special Solidarity Fund 93
• Supplements. A point of discussion however are the supplements linked
to treatment of chronically ill children that are currently eligible for
reimbursement by the SSF;
• Costs already borne by other insurances or reimbursement systems.
Switching to a franchise system does not imply that the currently existing case by case
handling discontinues to exist or would be radically changed, since a proper assessment
of the eligibility criteria remains necessary. Transitional measures for patients passing
from one system to another should be provided.
8.5.4 Coherent Drug reimbursement policy
Diseases, indications or medical situations that are currently not (yet) covered by the
compulsory health care insurance, risk to fall as a residual under the SSF umbrella.
Hence, the SSF is often considered as a temporary solution (‘waiting room’) for specific
or complex situations for which a framework for reimbursement has not been
established yet. This is especially the case for drugs, as they have been responsible for
the major part of the SSF expenses during the last years. As of today, drugs are often
reimbursed by the SSF during several years, with no real assessment nor a formal price
setting occurring in the meantime. Pharmaceutical companies are indeed not always
eager to introduce a request for reimbursement by the compulsory insurance system at
the Drug Reimbursement Commission (DRC; Commissie Tegemoetkomingen
Geneesmiddelen/Commission Remboursement des medicaments), because such a
request is a costly procedure. Commercial or financial arguments – in particular when
dealing with drugs for rare diseases with a small potential market - often seem to
restrain pharmaceutical companies from starting up this process. Moreover, in such
cases effectiveness is difficult to prove since the number of patients is inevitably small.
Entering an application for reimbursement of a drug (or expanding its indications) in the
compulsory health system also implies a discussion on price setting. The fact that
pharmaceuticals are reimbursed by the SSF for a very long period can have as an effect
that this discussion is postponed indefinitely. This may result in a discrimination against
patients with a disease or indication currently falling outside the scope of the SSF,
whereas patients with a rare disease or indication are to a large extent reimbursed by
the SSF.
Such a misuse results in the unjustified use of public means. One way to counter the
misuse of the SSF as a waiting room and/or the “bypass” of the regular system, would
be to request that the pharmaceutical firm submits an MA application (if not yet the
case) and commit itself to introduce a demand at the DRC.
On the other hand the SSF is regularly ‘misused’ or bypassed if the price the
pharmaceutical firm proposes for the drug was not accepted (for instance if the DRC
judged a priori that the proposed price is too high and does not assess the evidence). In
that case, the sole solution for the patient to get reimbursement of the product at stake
is the SSF. Systematic collaboration between the SSF and the different interfering bodies
regarding reimbursement policy and marketing authorization of drugs and implants, such
as for instance the DRC, the College van geneesheren voor weesgeneesmiddelen
(CMDOD) and the Federal Agency for Medicines and Health Products is therefore
necessary to avoid contradictory decisions and to centralize expertise.