Innovation in European healthcare – what can Sweden learn? - LIF

The assessment of public subsidy to outpatient medicaments -
The Danish Health and Medicines Authority
(Lægemiddelstyrelsen)
• There are two main criteria that must be full filled in
order for a drug to be granted general reimbursement
That is:
- The product should be a safe and valuable
therapeutic effect on a well-defined indication.
- The price of the medicament must be proportionate
to its therapeutic value
• In making this assessment, what is considered is the
drugs efficacy, side effects and costs - preferably in
comparison with other appropriate treatments, if such
treatments exist.
• In assessing new drugs, the clinical studies as basis
for a marketing authorisation is evaluated.
• The applier can send a health economic analysis to
elucidate whether the treatment is cost-effective. The
analysis should be carried out in accordance with the
lægemiddelstyrelses guidelines for such analysis’. It
is optional whether the applicant company will
enclose such an analysis. If no such is attached, the
board assess whether the price is reasonable
compared to its therapeutic value.
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If a health economic analysis
is attached to the application
of a new drug, the first
consideration deals with the
fact, if it will matter for the
decision of subsidy grant.
If that is the case, the health
economic analysis is
assessed by an external
healthcare economist from
KORA (The national institute
for the municipalities and
regions analysis and
research).
In assessing the subsidy,
there is no economic
framework or budget that
Lægemiddelstyrelsen has to
take into consideration.