Pricing and reimbursement
There is a mandatory health insurance scheme in Slovenia operated by ZZZS. In order for a medicinal product (which has obtained a marketing authorisation) to obtain a reimbursement status under the national scheme, it shall also obtain a highest permitted price in accordance with Article 157 of ZZdr-2. Said price is then the highest permitted wholesale price when marketing the product in Slovenia. The medicinal product shall obtain reimbursement status if ZZZS puts the product on the reimbursement lists (i.e., either the positive or intermediate list (Article 23 and the following of ZZVZZ)). If the medicinal product is so classified, it shall be paid for from mandatory health insurance either in full or in certain percentage of the price, while the rest shall be paid the patient's supplementary health insurance (or by the patient himself or herself if the patient has no supplementary health insurance). ZZZS may set limitations on prescribing or dispensing of medicinal products in the context of reimbursement, for example relating to indications or patient population, etc.
Once a generic product becomes available on the market, JAZMP shall put the original and the generic product on the interchangeable list (Article 19 of ZZdr-2). In the next step, ZZZS shall determine the highest recognised value for the product group on the interchangeable list. This price is set at the level of the cheapest product of the group on the interchangeable list (Article 40(1) of the Rules on Inclusion of Medicines on the List).22
Medicinal products may be prescribed by a physician by using the proprietary or the international non proprietary name (INN) (Article 24(1) of the Rules on the Classification, Prescribing and Dispensing of Medicinal Products for Human Use).23 If the product that is on the interchangeable list was prescribed with its proprietary name, but the price for that product is higher than the highest recognised value for the group of interchangeable products, the patient shall either co-pay for the prescribed product or the pharmacists may, without consulting the doctor, exchange the product for the cheaper one (unless the doctor noted 'Do not exchange!' in the prescription). If the product is prescribed using the INN, the patient choosing a product the price of which exceeds the highest recognised value shall co-pay for the product.
Irrespective of the interchangeable list, the ZZZS may put medicinal products with the same indications (with the same or different active ingredients) on the list of therapeutic groups. A highest recognised value is also set by ZZZS for each therapeutic group. If the prescribed product is on the list of therapeutic groups, the highest recognised value shall be paid from the health insurance and any difference is paid by the patient.
The above applies in general to reimbursement of medicinal products dispensed in pharmacies to patients presenting a prescription. Medicinal products to be provided or administered to patients in hospitals are purchased by hospitals in public tenders under the rules regulating public procurement. Medicinal products are typically paid for by the hospitals from their general budget as agreed with an annual general agreement between ZZZS and other stakeholders in the healthcare sector. Specific rules apply to medicinal products classified by ZZZS as hospital medicinal products (products administered in hospitals, the price of which exceeds €5,000 per patient per year) – called List B; and for products classified as products in ampoules and other medicinal products for outpatient treatment to be charged separately – called List A.
Medical devices may also be paid for from the mandatory and supplementary health insurance in accordance with ZZVZZ and the Rules on Mandatory Health Insurance.24 A standard is set for each type of medical device. The standard provides the price, material and duration of use. Distributors are obligated to make available standard medical devices without any co-payment. If a patient requires a better or a more expensive device, he or she shall co-pay for that device.