ISPOR Europe 2025

Managed Entry Agreements (MEAs) in CEE are often negotiated individually, leading to inconsistent access and varying financial outcomes. This panel will debate whether MEAs can be mutualized across CEE to offer harmonized frameworks and shared learnings, or if national heterogeneity renders mutualization impractical.

Moderator: Izabela Pieniazek, MSc, Certara

Speakers:

• Ron Hren, MSc, PhD, Hren, Slovenia
• Anna Kowalczuk, PhD, MSc, Agency for HTA and Tarriff System, Poland
• Guenka Petrova, ScD, PharmD, PhD, Medical University of Sofia, Bulgaria

Central and Eastern European (CEE) payers face a paradox: single-payer systems give them rich RWD streams yet reimbursement dossiers still require long timelines for both creation and adjudication, driven by capacity limitations. This presentation will cover the benefits of AI integration, such as increased efficiency and quality control, while also addressing potential pitfalls including reproducibility issues, unclear regulatory frameworks, and the risk of data manipulation or falsification.

Moderator: Vladimir Guzvic, Health Insurance Fund of Republic of Srpska, Bosnia and Herzegovinia

Speakers:

• Anna Kowalczuk, PhD, MSc, Agency for HTA and Tariff System, Poland
• Maciej Grys, Certara, Poland
• Kevin Kallmes, BS, MA, JD, Nested Knowledge, USA

This panel will debate whether it is feasible to develop a comprehensive regional roadmap guiding Central and Eastern European (CEE) nations from fragmented capacity-building activities toward fully integrated, sustainable HTA infrastructures. It will identify core components—governance, financing, and shared data platforms—tailored to CEE contexts.

Moderator: Malwina Holownia-Voloskova, MSc, PharmD, Certara

Speakers:

• Oleksandra Oleshchuk, PhD, MD, Horbachevsky Ternopil National Medical University, Ukraine
• Eva Turk, National Institute of Public Health, Slovenia
• Kelly Lenahan, BS, MPH, ISPOR

Authors: Malwina Holownia-Voloskova, Elena Chitan, Oresta Piniazhko, Antoan Rangelov, Grzegorz Obrzut

Authors: Malwina Holownia-Voloskova, Katarzyna Lasota, Marcin Czech

Authors: Noemi Hummel, Agnieszka Kopiec, Emi Naslazi, Ananth Kadambi, Claus C. Becker

Authors: Noemi Hummel, Agnieszka Kopiec, Matthew Crabtree, Alasdair, Charlotte Sharples, Biliana O. Veleva-Rotse, Neil Johnson, Vera Gielen

Sponsor: Amicus Therapeutics

Authors: Elzbieta Soltysiak, Jelena Sostar, Sanja Stanisic

Authors: Ilona Czarny-Ozga, Kamila Wojas-Krawczyk, Jakub Zolnierek, and Izabela Pieniazek

Authors: Aneta Gomulka-Pilat, Magdalena Kaczanowska, Agnieszka Kopiec, Izabela Pieniazek

Authors: Nadia Quignot ,Erika Braithwaite, Isabelle Ragueneau-Majlessi

Authors: Kurt Neeser, Elvira Mueller, Vishwas Agashe

Authors: Kurt Neeser, Elvira Mueller, Andrea Bernardini, Katarzyna Lasota, Sanja Stanisic

Authors: Maciej Grus, Kevin Kallmes, Jeff Johnson, Roman Casciano

Authors: Elvira Mueller, Kurt Neeser, Linnea Koller

Authors: Andrea Bernardini, Jelena Sostar, Vishwas Agashe, April Dominique Ocampo

Authors: Marine Mathias, Katarzyna Lasota, Sanja Stanisic, Jelena Sostar

Authors: Andrea Bernardini, Katarzyna Lasota, Sanja Stanisic