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

90 Special Solidarity Fund KCE Reports 133
These budgets are complemented if the hospitals treat patients that need expensive (or
orphan) drugs. Drugs for outpatients are reimbursed at 100% by Sickness Insurance on
the basis of their transfer price (prix de cession). This price comprises the purchase
price (based on price convention between the hospital and the pharmaceutical
laboratory) + lump sum margin for the costs of administration and distribution by the
hospital + VAT.
Belgium does not have a specific “early access to new drugs” system for patient groups
paid by public means. Early access to drugs for individual patients is possible via the SSF
(patient initiative). Early access to drugs for groups of patients is solely possible in within
the scope of compassionate use (for drugs which do not yet have obtained a MA in
Belgium) and medical need programs (which concerns medicinal products which have a
MA in Belgium for a given indication, but are used for another indication). These
programs are set-up and paid by the pharmaceutical company, and the medicines are
provided for free.
In France, however, the access to drugs without MA in France for groups of patients
can be financed with public means via the ATU procedure.
8.4.2 Centralisation of the treatment of rare diseases in reference centres
Rare diseases are complex and demand high expertise. In France as well as in Spain and
the Netherlands, knowledge and patient treatment is clustered in reference centres (or
specific hospitals). Costs of treatments and drugs are included in the reference centers’
budgets. The results from the SSF sample reveal that a small number of hospitals
present a large number of applications, which implies that “de facto” there is a kind of
reference centre system for rare diseases in Belgium. There is however no regulation
with regard to the systematic financing of the treatment in those particular hospitals.
At the European level, the High Level Group on Health Services and Medical Care
developed some principles regarding European reference networks for rare diseases,
including their role in tackling rare diseases and other conditions requiring specialized
care, patient volumes and some criteria that such centers should fulfill. European
reference networks should also serve as research and knowledge centers, updating and
contributing to the latest scientific findings, treating patients from other Member States
and ensuring the availability of subsequent treatment facilities where necessary.
8.5 OPTIONS FOR OPTIMISATION
When making the round up of the elements allowing an overall evaluation of the
functioning of the SSF, one cannot pass up on the theoretical reflection on the unmet
needs in a broader scope than the current legal framework. Starting from the actual
structure and operation of the SSF, possible alternatives and options to optimize the
management of high-cost, yet medically necessary care that is not reimbursed by the
compulsory health insurance are discussed. The focus of this chapter however is not the
implementation of possible alternatives, as these will mostly need further research.
Consequently we will not zoom into any feasibility constraints. Although this section is a
rather theoretical reflection and to this extent does not necessarily build on the results
presented in previous chapters, it has to be noted that some of the alternatives were
spontaneously mentioned by the stakeholders during the interviews.