Some Central European EU member states were relatively early adopters of health technology assessment (HTA) in the mid-2000’s. Poland, Czech Republic, Slovakia and Hungary all implemented HTA systems inspired by economic evaluation and especially the UK’s NICE—although with varying degrees of complexity, and a shared focus on budget impact besides cost-effectiveness. Romania and Bulgaria have been late followers. When Romania faced international lender pressure to increase efficiency and transparency in health care, it went for a checklist-based light HTA approach in 2014/15. Whereas Bulgaria implemented a system based on economic evaluation in 2016. Croatia, Slovenia and the Baltic states apply some assessment for new medicines, but no formalized HTA systems.
Ineffective HTA Systems?
Early adoption however, did not necessarily mean a fully successful implementation. HTA systems in the region kept working. They have become formally embedded into P&R decision making systems, but they have not been able to effectively support decision-makers. HTA and P&R decisions seem to have remained partly or fully detached from each other. In countries where HTA has reached a development stage that it is able to provide critical appraisal (e.g. Poland), HTA provides material input to manufacturer negotiations, but appraisals or negotiation results can be ignored or overruled in the last (political) stages of decision-making. In other countries (e.g. Bulgaria, or earlier Hungary), HTA retains a largely descriptive character by structuring information but missing out on providing prescriptive recommendations. And, in all countries, HTA systems have been widely criticized by non-governmental stakeholders as restrictive, budget impact focussed, and leading to excessive delays in P&R decisions.
Evolution of HTA Systems
On the other hand, after a decade of relative inertia, HTA systems in the region are seeming now to be opening towards broader policy considerations, more flexible assessment frameworks and generally more value-added to end users (policymakers and payers). The international trend in HTA of expanding scientific analysis and dialogue from methodologies to policy issues and stakeholder requirements appears to be strongly reflected in Central Europe, where exactly these factors need to be considered more strongly for HTA systems to work more efficiently. Whether this opening up will lead to positive, lasting transformations in systems is still unclear, but some interesting changes are underway:
- In Poland, there is ongoing policy discussion about modifying the allowable cost-effectiveness threshold (willingness-to-pay) for a new medicine based on the contribution the developing pharma company makes to the national economy. It is up to debate whether this approach has more benefits or risks, but the fact that there is a relatively strong current in policy which accepts the possibility of using more flexible cost-effectiveness thresholds is clearly indicative of changing thinking about HTA in Poland.
- In Slovakia, a partly similar process has been taking place: the previous extremely rigid cost-effectiveness (cost/QALY) threshold has recently been complemented by a multi-criteria decision analysis (MCDA) approach in which five modifiers are used to push the acceptable cost-effectiveness threshold—not only upwards but also downwards from the base value of 35 times the average monthly wage (down to 28x and up to 41x, respectively). The next major step in Slovakia is likely to be the implementation of managed entry agreements (MEAs) which have been missing from the Slovakian P&R system up to now— a quite unique situation for the Central European region.
- In Hungary, the health economics guidelines were updated in 2017 to allow for broader or alternative forms of economic analysis (e.g. cost consequence analysis), the inclusion of the societal perspective and, under specific conditions, the use of non-reimbursed comparators.
- In Romania, the current rudimentary (and quite rickety) checklist-based system cannot be expected to survive in the long run, however it is a question when and which type of system could best replace it.
All these developments suggest that HTA continues to evolve dynamically in the Central European region and although the exact outcomes of recent and ongoing changes are hard to predict, there seems to be a tendency towards broader and more flexible value assessment frameworks and methodologies.
More information on the course and registration can be found here: https://vscr.at/en/public-health/
Dávid Dankó, PhD, is speaker at the VSCR/SFU Diploma Programme in November 2018. He is working as Managing Director at Ideas & Solutions (I&S), an independent research and consultancy firm which provides health policy and market access advisory services to health insurance organizations and pharma and medical device companies. He is also Research Leader at Corvinus University of Budapest, where he lectures pharmaceutical policy and funding. He has 15 years of experience in health care management & the funding of pharmaceuticals and medical devices.
The Vienna School of Clinical Research (VSCR) and the Sigmund Freud University Wien (SFU) are holding international Diploma Programmes on Health Economy, Health Technology Assesement (HTA) and Decision Making for Pricing and Reimbursement. The first module takes place in Vienna from November 15th to 18th. Head lecturers are Keith Tolley, BA, MPhil, Director of Tolley Health Economics, University of York, UK and Lieven Annemans, MSc, PhD Senior Professor of Health Economy, University Ghent, Belgium, past president ISPOR