Health Technology Assessment (HTA) is gaining importance in systemic activities that assure access to important medicines to the citizens of the Republic of Slovenia and European Union. Its mainstream is dedicated to the assessment of relative effectiveness of medicines or relative performance of medical devices and in vitro diagnostic medical devices as well as other technologies. Applying scientific methodology, the presence of added value of health-related products and services related to the current standard of care or other comparators is assessed. HTA deliverables can serve as basis for further economic evaluations of the products and services and can support downstream pricing and reimbursement decisions.
In the Republic of Slovenia, HTA is currently not performed in a dedicated HTA institution. JAZMP is currently not an HTA competent authority, but is in the position to perform HTA-related tasks in pricing procedures as defined in Article 182 of the Medicinal Products Act (Uradni list RS [Official Gazette of the Republic of Slovenia], No. 17/14 and 66/19).
Administrative and professional tasks of JAZMP pertaining to the evaluation of medical technologies include the cooperation with other institutions of the national health reseau with the aim to prepare HTA reports, as well as the use of regulatory/professional expertise and JAZMP’s official databases to support HTA processes on the national and international level.
In addition, JAZMP was also involved in the ongoing EU-level HTA activities of the EUnetHTA Joint Action 3 project (2016 – 2021). In general, the main objective of EUnetHTA JA3 was to increase the use, quality and efficiency of joint HTA work at European level to efficiently support policy- and decision-making in the health systems. JAZMP participated in the project as one of the two affiliated entities (the other was the National Institute of Public Health) to the Ministry of Health, the national partner of the project. In the project, JAZMP was actively involved in the implementation stream of the project at the level of three (out of seven) work packages. In this frame, we participated in the preparation of the joint clinical assessment reports of the priority health technologies (EUnetHTA REA reports), using existing and in EUnetHTA JA3 developed methodologies and recommendations. Joint HTA assessments are intended for implementation on a national level, taking into account additional evidence and specific national health care needs in the decision making process.
JAZMP also participated in preparation of national position on the Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on Health Technology Assessment and Amending Directive 2011/24/EU, providing expert support to the Ministry of Health. The Regulation will establish a permanent HTA collaboration model at the EU level in 2025.
All the questions, suggestions and comments you may have regarding HTA should be sent by e-mail to:Â .