List of Highly Innovative Pharmaceutical Technologies (TLI)
On 10 March, work was completed on the latest edition of the list of highly innovative pharmaceutical technologies (TLI). The document was prepared based on the current evaluation criteria and submitted to the Ministry of Health, serving as the basis for further actions related to the reimbursement process.
As part of the preparation of the list, an analysis was conducted of medicines for which marketing authorization decisions were issued under the centralized registration procedure between 1 January and 31 December 2025, and for which the decisions were published by the end of last year. According to data from the European Medicines Agency (EMA), 109 medicinal products were authorized for marketing during this period.
Highly innovative drug technologies pertain to the areas of rare diseases and oncology, and the creation of the TLI list focuses on promising therapies within these disease groups.
After applying the selection criteria, 22 innovative therapies were qualified for evaluation. Separate evaluations were prepared for products with more than one indication, resulting in a total of 23 analyses.
Based on an evaluation conducted according to statutory criteria—i.e., taking into account the strength of the intervention, the quality of scientific data, unmet medical need, the size of the target population, and health priorities—a TLI list was created that includes 9 drug technologies.
The TLI list remains an important tool for supporting systemic processes—it enables the identification of the most promising drug technologies and thereby strengthens efforts aimed at improving patients’ health and quality of life.