Presentation (CTI)

OBJECTIVES: Central and Eastern European (CEE) countries face persistent challenges in ensuring timely and equitable access to innovative medicines. This study updated a previously published comparative analysis of medicine access in CEE by expanding the evidence base beyond orphan medicinal products to all European Medicines Agency (EMA)-approved medicines including oncology.
METHODS: An updated comparative assessment was conducted across seven CEE countries: Bulgaria, Czechia, Hungary, Poland, Romania, Slovakia, and Slovenia. The analysis built on a previously published mixed-methods framework incorporating literature review, expert validation, stakeholder interviews, and advisory board consensus. Updated access estimates were extracted for two outcomes: overall access as a percentage of all EMA approvals and oncology access as a percentage of EMA-approved oncology medicines, both excluding Named Patient Programs. These results were interpreted in relation to national HTA criteria, pricing and reimbursement timelines, early access mechanisms, managed entry agreements, and patient involvement in decision-making.
RESULTS: Access varied substantially across the region. Overall access to EMA-approved medicines ranged from 22% in Romania to 62% in Slovenia, with Bulgaria at 39%, Czechia 45%, Hungary 27%, Poland 40%, and Slovakia 27%. Oncology access was higher in most countries but remained heterogeneous, ranging from 23% in Romania to 60% in Slovenia; corresponding estimates were 57% in Bulgaria, 50% in Czechia, 32% in Hungary, 48% in Poland, and 25% in Slovakia. Countries with more flexible or multi-criteria HTA approaches and shorter reimbursement timelines generally achieved higher access. Slovenia showed the highest overall and oncology access, while Czechia and Poland demonstrated relatively stronger performance associated with more structured assessment pathways; in Czechia, formal patient involvement is an established component of the decision-making process as well.
CONCLUSIONS: Updated evidence confirms substantial access inequalities for EMA-approved and oncology medicines across CEE. Flexible HTA criteria, predictable reimbursement timelines, and broader value assessment appear critical to improving patient access.