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

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.