Publications:
Real-word evidence utilization in CEE

As part of the European Commission-funded H2020 project HTx Project – Next Generation Health Technology Assessment, members of the ISPOR Bulgarian Chapter/ BAPh collaborated with international team of experts to identify the main barriers for application of real world evidence (RWE) derived in the Western European countries for the purposes of CEE decision making in healthcare.

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The importance of RWD and RWE is increasing not only in Western European countries but also in CEE due to the necessity of improving regulatory processes and optimizing decision-making. Differences in databases, issues with the regulatory framework, different methodological approaches and a lack of effective collaboration are one of the most common barriers regarding the process of transferring RWE from Western to CEE countries. At present, there are few clear solutions to these challenges. In this respect identifying the barriers will help the experts to provide possible approaches for their overcoming.

Using real-world evidence in health (care from Western to Central and Eastern Europe: a review of existing barriers Kamusheva M, Nemeth B, Zemplenyi A, Kalo Z, Elvidge J, Dimitrova M, Ponten J, Tachkov K, Mitkova Z. Journal of Comparative Effectiveness Research 2022; 11(12). Doi:

AI in HTA in CEE

As part of the European Commission-funded H2020 project HTx Project – Next Generation Health Technology
Assessment, members of the ISPOR Bulgarian Chapter/ BAPh collaborated with international team of experts to identify the main barriers for implementing good practices to use artificial intelligence in HTA derived in the Western European countries for the purposes of CEE decision-making in healthcare.

Studies focusing on the AI usage for HTA decision making are scarce. AI and augmented decision making tools are a novel science, and we are in the process of adapting it to existing needs. HTA as a process requires multiple steps, multiple evaluations which rely on heterogenous data. The potential barriers could be classified as data related, methodological, technological, regulatory and policy related, and human factor related. Some of the barriers are quite similar, especially concerning the technologies.

Barriers to Use Artificial Intelligence Methodologies in Health Technology Assessment in Central and
East European Countries

Tachkov K, Zempleny A, Kamusheva M, Dimitrova M, Siitrola P, Ponten J, Nemeth B, Kalo Z, Petrova G.
Barriers to Use Artificial Intelligence Methodologies in Health Technology Assessment in Central and East
European Countries. Front Public Health 2022; 10:921226. doi: 10.3389/fpubh.2022.921226.

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Patient engagement in HTA in CEE

As part of the European Commission-funded H2020 project HTx Project – Next Generation Health Technology Assessment, members of the ISPOR Bulgarian Chapter/ BAPh collaborated with international team of experts to identify the main barriers for implementing good practices engage patients in HTA drived in the Western European countries for the purposes of CEE decision-making in healthcare.

Patients’ perspectives are important to identify preferences, estimate values and appreciate unmet medical needs in the process of research and development and subsequent assessment of new health technologies. Patient and public involvement in health technology assessment (HTA) is essential in understanding and assessing wider implications of coverage and reimbursement decisions for patients, their relatives, caregivers, and the general population. atient involvement practices, however, are limited in Central and Eastern European (CEE) countries without clear methodology or regulatory mechanisms to guide patient involvement in the HTA process. This poses the question of transferability of practices used in other countries, and might call for the development of new CEE-specific guidelines and methods.

Patient Engagement - Ispor Bulgaria Publications

Potential Barriers of Patient Involvement in Health Technology Assessment in Central and Eastern European Countries
Dimitrova M., Jakab I, Mitkova Z, Kamusheva M, Tachkov K, Nemeth B, Zempenyi A, Dawoud D, Delnoj D, Houyez F, Kalo Z. Potential Barriers of Patient Involvement in Health Technology Assessment in Central and Eastern European Countries. Front Public Health 2022; https://doi.org/10.3389/fpubh.2022.922708

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