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

92 Special Solidarity Fund KCE Reports 133
8.5.2.3 Innovative medical implants and techniques: interaction with the category 5 of
art. 35 § 3
The SSF procedure for this category has some points in common with category 5 of art.
35 § 3 of the Nomenclature which provides a conditional reimbursement of implants
and invasive devices with no proven clinical effectiveness and safety. The major
difference with the category 5 regulation is that the SFF procedure provides a limited
timeframe of reimbursement of 2 years and that reimbursement concerns individual
cases. It is unclear however what research design is used to evaluate the respective
implants. It has to be noted that the current application of the category 5 regulation
also rarely involves a research design needed to prove the added value of the emerging
technology. This approach can lead to budgetary failure or inappropriate use of
resources. Another possible negative effect is the diffusion of unevaluated medical
technologies and risk of safety problems. An elaborated description of a transparent and
scientifically valid procedure to evaluate medical devices early, ideally before being
introduced into the market, can be found in report nr. 44A. 44 Although category 5 of
art. 35 only deals with implantable devices, the procedure (or a similar one) can also be
applied to other medical devices.
8.5.2.4 From rare disease or rare indication to expensive medical care due to justified
medical treatment?
The category “rare disease and rare indications” limits the action field of the SSF
considerably. Given the SSF’s role as a subsidiary safety net, the focus of the SSF could
be broadened to expensive medical costs due to a medical treatment that is judged as
appropriate, regardless of the question whether the disease or the indication is rare or
not.
It should be noted however that some reflection on the notion of “justified medical
treatment” is necessary in case of implementation. It is obvious that misuse of the SSF
by pharmaceutical firms derogating from the regular circuit has to be avoided. If there is
no MA and/or reimbursement by the obligatory health care insurance for interventions,
drugs or implants for frequently occurring diseases or indications, this will often be due
to a weak evidence base or a disbelieve in the effectiveness by the respective firm
(Indeed, for more frequently occurring diseases, it is -relatively- easier to obtain
evidence in a shorter timeframe). One should avoid that patients are exposed to
insufficiently evaluated technologies
8.5.3 Alternative system: a franchise system for high medical expenses due to a
justified medical condition or treatment
Although falling outside the initial scope of this study, it is worthwhile to consider the
SSF from the perspective of the health insurance system as a whole in its societal
context. It is clear that the SSF is a residual system, aimed at avoiding people to incur
catastrophic expenses due to medically justified healthcare. Whether or not the level of
expense beyond which it is to be considered as catastrophic should be modulated by
the income of the patient or his household, remains debatable. If the SSF is indeed
considered as a residual safety net for justified healthcare expenses currently not
covered, for one reason or another, by the compulsory health insurance, it can be
questioned why it should be limited to people with e.g. a rare disease or indication. An
alternative system could be a franchise system for high medical expenses due to a
justified medical condition or treatment. To be sustainable, a deductible (franchise)
could be set. It could be envisaged to lower the deductible whenever high expenses are
still occurring during several consecutive year, so as to avoid impoverishment through a
chronic condition.
Besides the limitations set by the eligibility criteria, the following costs should continue
to be excluded from the system: