Transparency in Health Technology Appraisal Processes in Central and Eastern Europe Countries

OBJECTIVES: To review the practices regarding transparency in health technology assessment (HTA) processes in Central and Eastern European (CEE) countries.

METHODS: Data were collected through a structured, web-based survey administered to HTA experts in CEE countries.

RESULTS: Based on the analysis of answers from 8 countries: Bosnia and Hercegovina, Bulgaria, Estonia, Hungary, Latvia, Poland, Slovakia and Ukraine in all countries except Bosnia and Herzegovina, HTA is legally required with publicly available HTA methodology guidelines. Guidelines on disclosure are available in 5 countries, as well as the list of ongoing HTA assessments/appraisals. The assessment reports submitted to HTA agencies are published in 3 countries. The appraisal reports are prepared by the HTA body and published in the majority of countries. The final recommendation is published in 6 countries, with a summary in English in only one. The recommendations are preceded by a discussion between involved stakeholders in 5 countries, with relevant opinions publicly reported in 3 countries. Minutes of appraisal body meetings are published only in 2 countries. Answers on the parties deciding what data is undisclosed are diverse. The highest consistency is seen in disclosing information on target limit group, safety, experts’ details and concealing economic data on ICER/ICUR and its components (QALY gain and costs) as well as budget impact population size and related expenditures.

CONCLUSIONS: While HTA processes in CEE countries generally mandate transparency and provide publicly available guidelines, significant variability exists in the publication of assessment and appraisal reports. The reported data are inconsistently disclosed. Most countries do not report the list of authors and conflicts of interest. Standardization of sensitive information both reported and undisclosed is justified.