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Slovenia has engaged with Health Technology Assessment (HTA) for over two decades, but its system remains fragmented and underdeveloped. Until recently, responsibilities for evaluating health technologies were dispersed across multiple institutions without a central coordinating body or standardized methodology. Medicinal products have been subject to structured evaluation through the Health Insurance Institute of Slovenia, while other health technologies, including medical devices, diagnostics, and preventive interventions, have followed less consistent pathways under the Ministry of Health. The adoption of the European Union Health Technology Assessment Regulation), entering into force in January 2025, has provided new impetus for reform, requiring Slovenia to designate a national HTA body to participate in joint clinical assessments and align national processes with EU standards.
Methods
A mixed-methods analysis combining a narrative overview of HTA in Slovenia with findings from two multi-stakeholder workshops held in 2025. These workshops, which convened Slovenian and international experts, policymakers, clinicians, and patient representatives, explored opportunities and challenges for developing a robust HTA framework.
Results
Key findings highlight the need to strengthen methodological capacity, introduce systematic stakeholder engagement, ensure transparency, and integrate real-world evidence into decision-making. Particular emphasis was placed on expanding HTA to medical devices, diagnostics, and digital health technologies, and on anticipating future innovations such as artificial intelligence.
Conclusions
Slovenia now stands at a pivotal juncture. Establishing a central HTA body with a clear legal mandate, building national expertise, and leveraging regional and European collaboration is essential to creating a transparent, evidence-based, and patient-centred HTA system.
The EUnetHTA Core Model® is well-established in the HTA community. Some recommendations of corresponding guidance documents leave room for alternative methodological choices. Considering the new HTA regulation (HTAR), we aimed to identify needs for concretization (NCs) in EUnetHTA guidance and provide indicative methodological options.
Methods
We carried out a qualitative document analysis and structured group discussion. Twenty-two EUnetHTA documents were screened using transparent criteria. Identified NCs were classified into topics according to the PRISMA statement and presented to Austrian HTA practitioners (n = 11) during a structured group discussion. Participants rated NC’s importance. To identify potential solutions, selected key handbooks for generic (Cochrane) and HTA-specific (IQWIG/NICE) evidence synthesis were systematically reviewed and matching content was charted against the NCs.
Results
Thirty-two topics with varying numbers of NCs were identified, twenty-six during the screening process, and six from the group discussion. Most of the topics related to evidence synthesis methods (nine topics), evidence eligibility criteria (nine topics), risk of bias (three topics), and certainty assessment (three topics). Other topics related to information sources, search strategy, data collection process, data items, effect measures, and reporting bias. One or more methodological approaches and recommendations could be identified for each identified topic from the included methodological handbooks.
Conclusions
Our analysis identified a need for concretization in some EUnetHTA guidelines. The structured overview of methodological options may support HTA doers in adapting and applying the guidelines to the national and local practical context.
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