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

184 Special Solidarity Fund KCE Reports 133
adds more unnecessary paperwork to the process. It only makes the time
for a final decision longer. The only added value of the local sickness fund
is the accessibility for the patient but since knowledge at local sickness
fund level is low and the real initiator is the treating physician, there is no
real need for this.
• Entering applications directly to the SSF would avoid duplication of work.
Now an application is screened a first time at the local sickness fund level,
a second time at the sickness fund at national level and a third time at SSF
level (administrative services). There is no added value from the advice of
the medical advisor of the local sickness fund. Respondents see no need
to have the files transit at federal sickness fund level. Shortening the
administrative pathway can shorten the period towards a decision.
• The appeal procedure for SFF decisions is not appropriate. There should
be an internal appeal procedure avoiding having to refer to the courts of
law. Such an external procedure should be limited to very exceptional
situations (last resort).
9.13 RESULTS FOR THE INTERVIEWS WITH PHARMA.BE AND
REPRESENTATIVES OF FOUR PHARMACEUTICAL
COMPANIES
9.13.1 General remarks Pharma.be
The Belgian pharmaceutical sector sees a major problem in the fact that Belgium does
not have a specific system for “early access” to new drugs. For medication that already
has EMEA registration but where there is no reimbursement decision at Belgian level,
the only possible solution for having the costs reimbursed is to introduce an individual
application, at individual patient level, at the SSF.
In other countries as France an “early access system” exists as well at individual patient
level, as at patient group level (ATU - Authorisation temporaire d’utilisation). A
pharmaceutical company can introduce such a demand for early access in which case the
use of the new drug can be authorised for specific patient groups and/or indications
linked to a therapeutical protocol. In such a case, the pharmaceutical company has to
engage itself to introduce a demand for reimbursement at a later stage. The use of the
drug and reimbursement of costs however is already temporarily regulated. The
pharmaceutical industry proposes to have such an early access system introduced in
Belgium too. They do not think the SSF is the adequate instrument to provide such an
early access since the SSF is limited to only case by case decisions.
Most pharmaceutical companies understand that when a drug has not yet obtained the
EMEA marketing authorisation, and the drug is needed for the treatment of an individual
patient, the costs cannot be charged to the national health system. But if market
authorisation has been obtained, they find it’s the responsibility of the public health care
insurance system to cover the costs. They also ask to shorten the time that is needed
for acceptance of new drugs (after EMEA registration) into the Belgian health care
insurance system.
Compassionate use and medical need programs:
Compassionate use and medical need programs are not seen as a structural solution for
these situations. Both result in the fact that only the pharmaceutical company bears the
cost of these drugs. For some smaller Belgian companies this is not obvious. One
company mentioned compassionate use counts for about 1/12th of their gross sales in
Belgium. The difference between compassionate use and medical need program for the
company is, the compassionate use is completely at charge of the Belgian company as
for the medical need program the costs are at charge of the “mother company”.
• Compassionate use occurs when a drug has not obtained the EMEA
market authorisation yet (for the drug itself or for the very specific
indication for which it will be used for the treatment of the patient). The
pharmaceutical companies say that for rare indications it is not obvious to