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KCE Reports 133 Special Solidarity Fund 67
• and to collect information relative to the actual use of the medicinal
product during the ATU and pharmacovigilance with the view of drawing
up a periodic ATU report which is intended to be regularly transmitted to
AFSSAPS.
Each cohort ATU application is assessed by the Marketing Authorisation Committee of
AFSSAPS 19 . In particular, assessment deals with the pharmaceutical quality, safety and
efficacy of the medicinal product for the indication claimed, the draft protocol for
therapeutic use and information collection, the draft summary of product
characteristics, the draft patient information leaflet and labelling, the prescribing and
supplying conditions as well as the absence of therapeutic alternative available on the
French market.
A cohort ATU is granted for a fixed indication which must be respected. To the
authorisation are attached the summary of product characteristics, the patient
information leaflet, the labelling as well as the protocol for therapeutic use and
information collection. AFSSAPS also notifies the frequency of periodic ATU. Cohort
ATU is mostly granted for a duration of one year and can possibly be renewed.
The response times for ATU applications depends, first of all, on the therapeutic
emergency and, secondly, on the level of knowledge about the drug at the AFSSAPS.
When the medicinal product has already been evaluated by the AFSSAPS, the decision is
generally being made within 24-48 hours. When the medicinal product has never been
evaluated, the response time depends on the duration to compile the dossier and to
complete the assessment.
Periodic ATU reports are sent to AFSSAPS and, if applicable, to the regional
pharmacovigilance centers in charge of the national monitoring, according to a
periodicity set by AFSSAPS. They include a descriptive analysis of all the data collected
during the ATU validity period (data collected since the previous report and cumulated
data) in the context of the protocol for therapeutic use and information collection, as
well as any new relevant information on the medicinal product since the cohort ATU
was granted, particularly as regards actual conditions of use and safety.
Reimbursement of ATU-granted medicines
For ATUs that are followed by a MA, different reimbursement conditions apply
according to 3 periods (period between ATU and notification of MA, period between
notification of MA and entering into force of MA, period between entering into force of
MA and publication of the MA) 20 .
The following conditions solely concern the period between ATU and notification of
MA (for all cohort ATUs and possible for nominative ATUs) or ATU that is not
followed by a MA (most nominative ATUs).
In order to buy and supply ATU drugs, the drug needs to be registered on a list of
products ‘agréés à l’usage des collectivités”. ATU drugs are solely available in hospital
pharmacies or other diverse public health institutions but can be provided to
hospitalised as well as outpatients (retrocession).
Drugs with a cohort or nominative ATU not classified for hospital use only and for
outpatients are included in the reassigned list (articles R. 5126-103 et R. 5126-104 of
the public health Code - rétrocession). These reassigned ATU drugs are reimbursed at
100% by the health care 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. 21
19 for the composition of this Committee see: http://www.afssaps.fr/Activites/Autorisations-de-mise-sur-lemarche/Commission-nationale-d-autorisation-de-mise-sur-le-marche/(offset)/7
20 for more details see http://www.sante.gouv.fr/adm/dagpb/bo/2007/07-05/a0050112.htm
21 http://www.sante-sports.gouv.fr/IMG/pdf/medicaments-2.pdf