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

68 Special Solidarity Fund KCE Reports 133
When drugs are administered to a hospitalised patient, the cost of any cohort or
nominative ATU drugs is met by the health establishment treating the patient. This
expenditure is covered by the establishment’s financial allowance for missions of general
interest and by assistance for contracting. This allowance can be increased to cover
exceptional or unanticipated expenditure related to the purchase of ATU drugs.
7.1.2 Rare and chronic diseases in France
The French government elaborated an ambitious National Plan for Rare Diseases 2005-
2008 (Plan National Maladies Rares 2005-2008) 33 . The Plan has the general aim to
improve the equal access to healthcare services for rare disease patients (from the
diagnosis phase to the reimbursement of costs) and puts forward following 10 priorities,
amongst others:
• A deeper knowledge of the epidemiology of rare diseases;
• Recognition of the specificity of rare diseases;
• Dispersion of information to the general public and healthcare providers;
• Education of healthcare providers on the diagnosis of rare diseases;
• Improvement of the quality of care;
• Investments in research on orphan drugs;
• Etc.
One of the priorities is the establishment of about centres of reference who were
awarded the label by the Minister of Health for five years. The centres have a double
role: they intervene as expert centre for one or more rare diseases and they are the
resource centre for patients coming from outside the region. The French government
budget €100 millions (spread over 5 years) to realize the plan.
In France, the level of reimbursement of patients suffering from a rare disease is
strongly linked to the recognition of their disease as a chronic disease.
Recognition of chronic diseases (Affectation de longue durée - ALD) is defined by the
Social Security Code (Article L 324 du Code de la Sécurité Sociale). The patient’s
referent GP (médecin référent) diagnoses the chronic disease and elaborates a so-called
‘treatment protocol’, describing the pathology and prescribing the required treatment.
Finally, the medical committee of the public health insurance fund (Caisse d’Assurance
Maladie) takes a decision, based on the request for recognition that was submitted by
the referent GP.
People that suffer from a chronic disease are exempted from cost-sharing and thus fully
reimbursed by the public health insurance fund (called exoneration du ticket
modérateur). However, this is only true for healthcare expenses that are linked to the
treatment of their chronic disease and not for any other disease. The exemption period
from cost-sharing is mentioned by the decision of the Medical Council of the Health
Insurance Fund (Caisse d’Assurance Maladie) and can be extended.
In France, three categories of chronic diseases can be distinguished:
• Chronic diseases that are listed as ‘ALD 30’, or diseases that require an
extend period of treatment and an expensive treatment. The list of these
30 chronic diseases are defined and adapted by the Minister of Health
(e.g. article L. 322-3-3° et article D. 322.1 du Code de La Sécurité
Sociale/décret n° 2004 - 1049 du 4 Octobre 2004 34 ). The majority of
‘orphan diseases’ (maladies orphelines) are considered as ‘ALD 30’ and
appear directly or indirectly on this list (see annex 9.14.4).
• Chronic diseases that are not listed as ‘ALD 30’, but that are recognised
as a chronic disease (Affections ‘Hors liste, article L. 322-3-4° du Code de
la Sécurité Sociale). It concerns diseases that require a period of
treatment that is exceeding 6 months as well as an expensive treatment.
Examples of affections ‘hors liste’ are :
o malformation congénitale des membres ;