Role of health technology assessment in the process of implementation of the EU Transparency Directive: relevant experience from Central Eastern European countries

Abstract

A total of 7 years after the addition of Poland, the Czech Republic and Hungary to the EU, the pricing and reimbursement regulations introduced in these countries are still considered to be not fully compliant with Directive 89/105/EEC, commonly referred to as the 'Transparency Directive' (TD). The TD aims to ensure the transparency of the pricing and reimbursement processes for medicinal products established by the member states. Among the most difficult barriers on the way to successful implementation of the TD discussed are meeting the timelines indicated by the TD, the implementation of objective and verifiable criteria for decisions, and the availability of remedies for negative decisions. Health technology assessment (HTA) has been introduced in to the reimbursement systems in Poland, the Czech Republic and Hungary almost simultaneously to their accession to the EU. Even though Central Eastern European (CEE) countries faced similar challenges during the transformation to a democratic system, certain differences in the extent to which HTA principles have been implemented in these countries could be distinguished. Hence, it is thought-provoking to consider the different views of HTA experts on the role of HTA in the adaptation of the TD in the CEE region. The key objective of this article will be to discuss whether the adaptation of HTA principles has supported or only triggered additional challenges in the process of successful implementation of the TD in the CEE region. In particular, the article will discuss whether the introduction of mandatory HTA recommendations or explicit willingness-to-pay threshold would encourage or discourage implementation of the TD. The importance of the independent HTA agency as a condition for successful introduction of the TD will also be debated.

HTA Implementation Roadmap in Central and Eastern European Countries

“…Several CEE countries, however, established and published thresholds for the cost‐effectiveness criterion. Cost‐effectiveness thresholds can be soft or hard depending on how much deviation is allowed in policy decisions compared with conclusions of the economic evaluation (Kolasa et al ., ). In Poland and Hungary, cost‐effectiveness thresholds are soft, that is, new technologies with incremental cost‐effectiveness ratio (ICER) above the published threshold still can be reimbursed, especially if they provide solutions to high unmet medical needs or inequities and their budget impact is relatively small, such as orphan drugs in rare diseases (Grzywacz et al ., ; Szegedi et al ., ).…”

When health technology assessment is confidential and experts have no power: the case of Hungary

“…Hungary established its own HTA Department, an organisation tasked with reviewing proposals for reimbursement of health technologies, in 2004. It had just acceded to the European Union (EU) and this was means of complying with the EU's Transparency Directive (Gulácsi et al 2009;Kolasa et al 2012). Since its inception the HTA Department has moved among various organisational structures and currently lies within the National Institute of Pharmacy and Nutrition (NIPN), a licensing authority for pharmaceutical and public administrational matters.…”

Criteria for Drug Reimbursement Decision-Making: An Emerging Public Health Challenge in Bulgaria

“…So have the Eastern European countries (7)(8)(9)(10)(11). Nevertheless, challenges remain when it comes to the role of HTA in public health decision-making as well as to human resource capacities of these countries (11).…”

“…Lack of technical expertise and poor governance can limit the use of HTA (10). Implementation of objective and verifiable criteria for decisions, and the availability of remedies for negative decisions are often stated among the most difficult barriers on the way to successfully address HTA issues in Eastern Europe (7). Moreover, there is a globally growing interest in the systematic setting of priorities in public health reimbursement decisionmaking (1).…”