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KCE Reports 133 Special Solidarity Fund 77
• Regarding treatment outside the hospital (extra muros), medicines that are
listed under the Drug Reimbursement System are compulsory reimbursed
by the health insurance providers under the standard benefits package. The
Drug Reimbursement System distinguishes between different categories of
medicines, regarding their reimbursement: Schedule 1A: medicines for
which an alternative exist that is 100 % reimbursable. Maximum limit of
reimbursement/patients has to pay an absolute amount; Schedule 1B:
medicines that are 100% reimbursable; Schedule 2: medicines which require
an authorization, in order to be (partially of fully) reimbursable
7.3 SPAIN
An introduction to the Spanish healthcare system and the organization of healthcare
provision can be found in annex 9.16.
7.3.1 Rare diseases in Spain – coverage of costs of treatment and medication
In Spain there is at this moment no specific framework for the treatment of patients
with rare diseases. The medical and pharmaceutical treatment is part of the global NHS
system and medical care as well as drug prescription and the use of medical devices is
regulated by in the overall ‘cartera de servicios’. If a treatment or medication needed
for the treatment of patients with rare diseases is not included in this ‘cartera’, normally
the costs are not financed by the NHS.
The last decade different initiatives have been taken to improve the care to patients
with rare diseases. Till now a global plan for rare diseases does not yet exist at national
level. At regional level, several Autonomous Communities developed their own
regional plans but these are not integrated. Even if some of these plans provide
additional coverage of treatments and medication for patients with rare diseases, these
are only accessible for the citizens living in these specific regions. 37-39 As such these
regional plans lead to unequal care provision. In some regions certain types of
medication, devices or products will be included in the regional ‘cartera de servicios’
and be provided free of charges at hospital level or with (limited) co-payment if
delivered at local pharmacies whereas in other regions patients will have to pay for
them. Such plans or approaches at this moment have been introduced in the regions of
Andalucia, Extremadura, Cataluña and País Vasco (Plan de Genética). In other regions
rare diseases are not even mentioned as an issue in the regional health plans.
In 2007, the Spanish Senate adopted a resolution to set up a study to analyze the
specific situation of patients with rare diseases and to examine gaps in the NHS. Very
recently, during the last month of June, the Spanish Ministry of Health launched a
‘strategy on rare diseases’. 40 The aim is to improve knowledge on rare diseases,
improve accessibility of care and coverage of costs of treatments and medication in the
NHS.
7.3.1.1 Reference centers
One of the measures that were taken to improve the provision of medical care and
assistance for the treatment of rare diseases or special (exceptional) care is the creation
of ‘Reference centers’ (CSUR – Centros, Servicios o Unidades de referencia). Till now
more than 80 such reference centers have been recognized and integrated into the
NHS. In principle access to these centers has to be guaranteed to all Spanish citizens.
These reference centers sometime can be very distant from the home location of the
patient. To overcome this obstacle, special provisions for travel costs have been
introduced. Since the reference centers are part of the NHS, treatment as well as
medication is to be provided at no cost for the patients. 41