Collaboration on HTA within the EU - What does it Mean for CEE Countries?

Published Aug 16, 2022

The European Union (EU) has made significant steps recently towards a strong collaboration on Health Technology Assessment (HTA). The ultimate goal is a permanent framework for joint work, that includes joint scientific consultations, and joint clinical assessments among other potential areas of collaboration. This can potentially bring significant changes to the everyday practice of HTA institutions in EU member states and beyond. Members of the ISPOR Central and Eastern Europe (CEE) Consortium agreed that this timely topic is definitely worth discussing at a forum hosted by the Consortium at the ISPOR 2022 Conference.

Bertalan Németh, PhD, Chair of ISPOR CEE Consortium Executive Committee and Principal Health Economist of Syreon Research Institute, Budapest, Hungary, opened the session with a few key definitions, and highlighting the importance of the latest EU regulations on HTA.

Gergő Merész, MSc Head, Department of Health Technology Assessment, National Institute of Pharmacy and Nutrition (OGYÉI) Budapest, Hungary, explained that critical appraisal reports on manufacturer submissions are covering clinical and economic domains and their conclusion are legally non-binding to the payer in Hungary. The National Institute of Pharmacy and Nutrition hosts the local HTA expertise to prepare such critical appraisal reports in the public administration. The most recent change to the legal framework of HTA is a national-level change (the revision of the local guidelines of health economic evaluation) and most importantly, a significant union-level change, that is, the publishing of the European HTA Regulation.

On top of delivering joint clinical evaluations, the Regulation expects Member States to exchange information or data between each other that was not part of the joint clinical assessment. This inflow of data implies research needs to incorporate the additional information to the critical appraisal reports in an efficient and meaningful manner. The Department of Health Technology Assessment made significant research efforts to be able to derive conclusions on relative effectiveness based on the submitted clinical evidence, by developing a procedure for treatments of solid tumors similar to the ones used by other Member States. Moreover, as an improvement to the critical appraisal procedure, a framework for identifying, quantifying and interpreting the sources of uncertainty in economic evaluations has been implemented.

The revised guidelines for health economic evaluations and the investments to local methods will deliver tangible benefits for all stakeholders, both in the form of more clear expectations towards submission dossiers, as well as more predictable critical appraisal reports. Overall, this is hoped to create a synergy that increases the added value of HTA in Hungary to achieve better informed reimbursement decisions.

Oresta Piniazhko, PhD, Director of HTA Department, SEC of Ministry of Health, Kyiv, Ukraine

provided a review for the results of HTA implementation in Ukraine and first time of managed entry agreement (MEA) implementation based on HTA development and roadmap in Ukraine.

According to a recent qualitative study on the progress of HTA development in Ukraine, the overall level of satisfaction with the implementation of HTA in Ukraine by stakeholders was 100% with some suggestions for improvement.

Up until the date of forum (May 17 2022), the authorized HTA Department has published 30 HTA reports with recommendations for the Ministry of Health (MOH), and 8 medicines of which contain a recommendation to consider the possibility of negotiating MEAs. The recommendations are publicly available on the website of the department (

Additionally, experts of the HTA Department participated in the international cooperation and joint assessments with EUnetHTA in 5 projects as dedicated reviewers and observers. This experience developed credibility, supported with learning and education of experts for future cooperation and perspective collaboration as the HTA Department is a member of EUnetHTA since 2019.

The HTA implementation in Ukraine is aimed at improving patient access to medicines at the expense of the state budget that meets best international practice and showed prospective implementation of use of these tools in practice despite the time of war in Ukraine since 24th of February 2022.

Maciej Niewada, MD, PhD, Professor of Department of Clinical & Experimental Pharmacology Medical University of Warsaw and CEO of HealthQuest, Warsaw, Poland, explained that regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 specified that harmonized approach to clinical assessment across EU Member States should improve the availability of innovative health technologies for EU patients; ensure efficient use of resources and strengthen the quality of HTA across the EU; and improve business predictability. Among beneficiaries of that approach, one can identify patients, decision-makers (due to the availability of tools to capture the added clinical value and appropriate pricing as well as less political pressure), representatives of the pharmaceutical industry and HTA consultancies, as well as organizations of medical professionals and generally countries of less potential/capacity in the field of health technology assessment. Doubts may also arise from issues such as the duration of the assessment and the timeliness.

Collaboration in the field of HTA on the European Union scale poses a challenge in terms of differences at the local level in the areas such as: submission scoping and related target populations and comparators, approach to treatment outcomes and different assessment methods (e.g. MCDA, indirect comparisons). In addition, potential discrepancies may arise from locally specific arrangements on rare diseases, advanced therapy medicinal products (ATMPs) or digital technologies. Finally, health priorities remain local in specificity and responsibility.

Zoltán Kaló, PhD, Professor of Health Economics, Center for Health Technology Assessment, Semmelweis University, Budapest, Hungary, was the on-site moderator of the session, which led to a lively discussion with some generalizable conclusions. Although the HTA capacity building has been quite successful in the region since the establishment of ISPOR CEE Consortium, the need for international collaboration both within CEE and the entire Europe has become stronger than ever due to the expected influx of high-cost technologies. This is especially true for lower income European countries, who need to reserve their limited HTA resources on the local economic value assessment by avoiding duplication of efforts in relative effectiveness assessment.

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