Issues for countries considering introducing the "fourth hurdle": the case of Hungary.

OBJECTIVES: This study outlines the needs and current development of the "fourth hurdle" (i.e., requirement of effectiveness and cost-effectiveness data for drug coverage policy decisions) in Hungary, describes the legal background and seeks to address some of the most important questions in this field.
METHODS: The study draws on international experiences and discusses five issues that a given jurisdiction needs to consider before introducing the "fourth hurdle" for pharmaceuticals.
RESULTS: The "fourth hurdle" is very relevant in Hungary because many existing drugs are unevaluated and many new, expensive drugs are becoming available. On the other hand, the existing resources for health technology assessment, including economic evaluation, are quite limited. All the five issues are relevant in the Hungarian setting and were helpful in determining exactly how the "fourth hurdle" should be applied.
CONCLUSIONS: The most important issue seems to be that the implementation of the "fourth hurdle" needs to be achieved in a way consistent with the limited resources for HTA in Hungary. Specifically this means that, in setting priorities for drugs to evaluate, additional criteria need to be applied. In particular, priority should be given to assessing drugs that have been evaluated in other countries, because this affords the opportunity to adapt existing studies or models to the Hungarian situation.