Presentation (CTI)

OBJECTIVES: Slovenia uses external reference price system for determining the Maximum Allowed Price (MAP) of MPs for human use. Marketing Authorization Holders (MAHs) have the option to apply for EHAP, in case of rejection they are allowed to decline the publication of MAP (iMAP). The objective was to analyze the trends within regulated prices and their impact on expenditure.
METHODS: Publicly available information on regulated prices of MPs from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) from January 1st, 2021 to June 1st, 2026 and on volume and value consumption of reimbursed MPs from the Health Insurance Institute of Slovenia (ZZZS) from January 1st, 2021 to December 31st, 2025 were analyzed using Excel.
RESULTS: The number of MPs with regulated price has slightly increased (4,583 to 4,774; +4.2%). Within, the amount of EHAPs has decreased significantly (873 to 602; -31%), while the number of iMAPs has almost quadrupled (103 to 393; +381%), with the biggest increase observed in the second half of 2025, coinciding with the introduction of Most Favored Nation (MFN) announcement in the United States. The sales value of EHAPs has dropped considerably (92.7M to 73.2 EUR; 21%) with top 10 best-selling MPs making 16.3M EUR in 2025. The average mark-up over relevant MAPs, estimated by the top 10 best-selling MPs, is 60%. The sales value of iMAPs has tripled (73.8M to 221.7M EUR; +200%).
CONCLUSIONS: In the observed period, the amount of EHAPs has decreased, while the amount of iMAPs has increased considerably. These trends could be explained by competing influence of increased expenditure restrictions from ZZZS and the increased pressure of other reference pricing systems, including MFN. MAHs are fully exploiting the iMAP clause to minimize the impact on other countries. The main limitation of the analysis is inability to include confidential prices.