Do HTA Process in Central and Eastern Europe Countries Improve the Availability and Accessibility of Advanced Therapies: A 3-Year Analysis for Bulgaria, Romania, and Poland

Speaker(s)

Ivanova B1, Turcu-Stiolica A2, Manova M3, Gierczyński J4, Naidin MS2, Savova A5, Czech M6, Petrova G7, Kamusheva M8
1Medical University of Sofia, Sofia, 23, Bulgaria, 2University of Medicine and Pharmacy of Craiova, Craiova, Romania, 3Medical University of Sofia, Sofia, Sofia, Bulgaria, 4Researcher Institute of Healthcare Management, Lazarski University, Warsaw, Poland, Warsaw, Poland, 5Medical University of Sofia, Sofia, Bulgaria, 6Ministry of Health, Warsaw, Poland, 7Medical University-Sofia, Faculty of Pharmacy, Sofia, Bulgaria, 8Faculty of Pharmacy, Medical University of Sofia, Sofia, 22, Bulgaria

OBJECTIVES: The aim is to analyze health technology assessment (HTA) process and its specificities concerning advanced therapy medicinal products (ATMPs), and to review the progress in their market access over a 3-year period in three Central and Eastern European (CEE) countries: Bulgaria, Romania and Poland.

METHODS: A specifically designed questionnaire containing a section on the HTA process related to ATMPs and their availability and accessibility, was sent to HTA experts from the countries of interest. The responses were collected at two different points of time, 2021 and 2023.

RESULTS: In all three countries, the HTA process is obligatory for ATMPs, but no specific guidelines are available. The duration of HTA assessment and appraisal for ATMPs is the same as for other medicinal products. Additionally, none of the three countries have established a specific willingness to pay threshold for ATMPs.

Regarding the availability and accessibility of ATMPs over a 3-year period in Romania three ATMPs, one cell-based gene therapy and two gene therapies, were reimbursed each with specific requirements for prescribing and administration. In Bulgaria only one application of a gene therapy was submitted, and the process is still ongoing. In Poland three cell-based gene therapies and one gene therapy were reimbursed.

CONCLUSIONS: The main challenges such as high treatment costs, uncertainty in clinical effectiveness, and inadequate HTA methodological approaches for ATMPs, are also present in CEE countries. Reliable, nationally oriented programs for HTA and adequate financial coverage of ATMPs are not yet implemented. No prioritization conditions for the HTA of ATMPs have been identified in the selected countries. Over the 3-year period, the HTA process for ATMPs has not changed significantly. The number of ATMPs assessed and available in Romania and Poland has increased. However, CEE countries lag behind Western European countries in terms of the ATMPs availability for the patients.

Code

HTA342

Topic

Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes, Pricing Policy & Schemes, Reimbursement & Access Policy, Systems & Structure

Disease

Genetic, Regenerative & Curative Therapies, Oncology, Personalized & Precision Medicine, Rare & Orphan Diseases