Reimbursability of medicines
Once the pharmaceutical company has obtained the marketing authorisation,
it can introduce the medicine for patient use. Often, the sales do not start until the authorities have made the decision to include the medicine in the reimbursement system.
The reimbursability status of medicine means that society participates in paying the medicines expenses and reimburses the medicine user, through Kela, for part of the medicine price. The reimbursement can be given to the patient directly by the pharmacy.
The medicines in the reimbursement system are mainly prescription-only products, with the exception of self-care medicines prescribed by the doctor and basic creams prescribed for skin diseases. About 90% of the prescription-only medicines and about 60% of all medicines available in the pharmacies are reimbursable.
The patient can have the Kela reimbursement for the medicine only when the Pharmaceuticals Pricing Board (PPB) operating under the Ministry of Social Affairs and Health has made a decision on its reimbursement status.
In its application, the pharmaceutical company gives reasons on the need for the medicine and provides study results, for example, on the medicine benefits and adverse effects as well as on its expected sales volumes. The cost-effectiveness of a medicinal product containing a new pharmaceutical substance and of a new significant indication must be shown through a health economic report.
The medicine can have a basic reimbursement status, 40% of the price, or a special reimbursement status which is either 65% or 100% of the price. If the share paid by the patient on all reimbursable medicines used in a year is in excess of the patient deductible (so-called ceiling of medicines costs), the patient only pays a 2.5 euro deductible on each reimbursable medicine.