CEE Expert Guide on the reimbursement of orphan drugs in Slovakia

Yes. A reference is made to EU legislation.

Yes, either as categorised drugs or on exception.

In general, all medicines, including orphan medicines as well as medicines for serious diseases and innovative medicines, are required to pass a pharmacoeconomic analysis. This means that the medical necessity of the medicine for Slovak patients will be assessed, including its financial efficiency and budgetary impact.

In the case of categorised drugs, total or partial reimbursement is mandatory (categorised orphan drugs are usually fully covered). A drug is categorised at the MAH’s request if the drug fulfils certain criteria. The subsequent assessment is performed by the expert working group on Pharmacoeconomics, clinical outcomes, and health technology assessment at the Ministry of Health. It focuses on cost-effectiveness and budget impact. The final opinion may include clinical outcomes or health technology assessments; medicines indicated for diseases with prevalence less than 1:50,000 do not need to provide a pharmacoeconomic assessment.

In the case of a non-categorised drug, it may be reimbursed for a certain patient or patient group. This decision is a subject of the health insurance company. There are no clear criteria for exceptional reimbursement.

Both. In general, permanent reimbursement of orphan medicinal products exists only in the case of medicinal products included on the list of categorised medicinal products.

Yes, exceptions are possible. The proposal of the doctor concerned must be approved by the Ministry of Health and the relevant health insurance company. It should be added that these exceptions are very rare.

The exact number is unavailable, however the number is usually between 10-20 a year.

In the case of orphan medicinal products which are uncategorised, the reimbursement of the medicinal product is individualised according to the circumstances of the case.

Not at the moment.