RESUMO
OBJECTIVES: Middle-income countries often have no clear roadmap for implementation of health technology assessment (HTA) in policy decisions. Examples from high-income countries may not be relevant, as lower income countries cannot allocate so much financial and human resources for substantiating policy decisions with evidence. Therefore, HTA implementation roadmaps from other smaller-size, lower-income countries can be more relevant examples for countries with similar cultural environment and economic status. METHODS: We reviewed the capacity building process for HTA implementation in Hungary with special focus on the role of ISPOR Hungary Chapter. RESULTS: HTA implementation in Hungary started with capacity building at universities with the support of the World Bank in the mid 90's, followed by the publication of methodological guidelines for conducting health economic evaluations in 2002. The Hungarian Health Economics Association (META) - established in 2003 - has been recognized as a driving force of HTA implementation. META became the official regional ISPOR Chapter of Hungary in 2007. In 2004 the National Health Insurance Fund Administration made the cost-effectiveness and budget impact criteria compulsory prior to granting reimbursement to new pharmaceuticals. An Office of Health Technology Assessment was established for the critical appraisal of economic evaluations submitted by pharmaceutical manufacturers. In 2010 multicriteria decision analysis was introduced for new hospital technologies. CONCLUSION: The economic crisis may create an opportunity to further strengthen the evidence base of health care decision-making in Hungary. In the forthcoming period ISPOR Hungary Chapter may play an even more crucial role in improving the standards of HTA implementation and facilitating international collaboration with other CEE countries.
RESUMO
BACKGROUND: In middle income countries the number of trained health technology assessment specialists is limited and the public budget for health technology assessment is considerably lower compared to developed countries. These countries therefore must develop their own solutions to improve the quality and efficiency of health technology assessment implementation in reimbursement decisions. Our study aimed to develop a scientifically rigorous and detailed appraisal checklist for economic evaluations of pharmaceuticals in the single health technology assessment process. METHODS: The research design entailed a review of economic evaluations, submitted for reimbursement of pharmaceuticals, by two independent academic reviewers to identify the most common methodological problems. Fifty economic evaluations submitted in 2007-2008, randomly selected by the Health Technology Assessment Office served as data sources. The new checklist was developed by an iterative working process: first by assessing ten economic evaluations, then improving the checklist by generating new question items, then employing the improved checklist to assess the next ten economic evaluations. After appraising 25 documents, the reviewers reconciled their opinions and improved the checklist with the researchers of the Health Technology Assessment Office during an expert panel discussion. The reviewers scrutinized the second 25 economic evaluations, after which the expert panel finalized the checklist with consensus. RESULTS: The final checklist consists of 91 yes or no questions in 11 main topics concerning comparator selection, efficacy, effectiveness, costs, sensitivity analysis, methodological approach, transparency, and interpretation of results. The new checklist is based on current Hungarian evaluation practice. As the published checklist will be part of the official single health technology assessment process of pharmaceuticals, submitters will be able to assure the quality of their economic evaluation. CONCLUSIONS: The transparent critical appraisal method should improve the consistency of pharmaceutical reimbursement decisions and facilitate the utilization of economic evaluations in other fields of health care decision-making in other Central-Eastern European countries.
