Health policy decision makers and public funders are faced with the challenge of making choices for health investments to improve the healthy life expectancy of Europeans within the context of constrained resources. Health investments relate to any new technology for the diagnosis, prevention or treatment of disease.
It is not clear to which extent recent decisions on such health investments have been optimal. Public funders sometimes, but increasingly, evaluate the impact of health investments, but there is a lack of standardised procedures and criteria. This is even more the case for investments related to screening and diagnosis of disease, and in particular gene technologies.
The objectives of this study were:
Literature reviews identified existing methods for evaluating health investments and described existing procedures and criteria within MS for making and evaluating decisions on HISD. In parallel, experts and stakeholders were invited to participate in three surveys allowing a better understanding of the commonalities and differences between MS. Based on this, a draft tool, comprising procedures and criteria for evaluating HISD was proposed. The draft tool was assessed by a panel of experts guiding its iterative development. Finally, ways for implementing the tool and for the evaluation of HISD in MS were proposed together with recommendations and political implications at EU level.
Over recent decades, the possibilities for the prevention, diagnosis and treatment of disease have expanded throughout the EU. Medical care is changing dramatically becoming more ambitious and possibly more effective but it is also becoming more expensive. This has stimulated most European countries to increase the emphasis on containing the costs of their health care systems.
However cost-containment is not synonymous with providing cost-effective care. Ideally, the effectiveness and quality of care provided must be carefully evaluated in relation to their costs with the aim of maximising health gains within the available healthcare budget.
In a world with scarce resources, the cost-effectiveness of health investments and their impact on the population should receive increased importance as criteria for decision-makers. The European Parliament and the European Commission have stressed that the promotion of population health is a key factor for long-term economic growth and social welfare. New health technologies offer the potential to improve health by targeting effective and safe treatments and to provide health care in a cost-effective manner.
Society is now in a period of transition moving into genomic-based clinical decision-making paradigms that will require substantial health investments over the next decade. Because of this evolution, it is possible that there is an even stronger need to review health investments to assess their effectiveness and impact and develop a set of procedures and criteria that aim to evaluate how well such investments meet the needs of the population by maximising health gain and using resources in a cost-effective way.
Given all of the above, it is disappointing to observe that there is still so little information about quality, cost-effectiveness and accessibility of healthcare services among MS. Moreover, it is not clear to which extent recent decisions on health investments have been optimal. Public funders sometimes evaluate the impact of their health investments, but anecdotal evidence suggests there is a lack of standardised procedures and criteria. This seems even to be more the case for investments related to screening and diagnosis of disease, which is a cumbersome observation, especially given the surge of genomic-based technology in this specific field.
The purpose of this scoping study was to set up, together with a panel of experts, a common set of procedures and criteria (the ‘tool’) for the evaluation of health investments related to screening and diagnosis of disease across Europe, with a special focus on gene technologies.
The tool was to be formed by a set of recommended procedures and criteria for the assessment of such health investments.
It was also to contain guidance for obtaining an easy overview of health investments in this field. Within the context of the proposed project, the applicability of the tool was to be tested by evaluating selected recent health investments related to screening and diagnosis in EU member states.
This tool was to:
The project was completed in 2012. A database of evidence papers related to emerging genetic testing was established. We found that currently in the EU, the decision making process on reimbursement of such tests shows enormous differences in terms of:
Coverage decisions about genetic tests frequently appear to be made outside of the scope of national decision making bodies, presumably on a local decision making level.
The consortium therefore created a toolkit to be applied for the assessment of those screening/diagnostic technologies that claim to have an added value. The tool shows several similarities with existing tools that aim at better applying health technology assessments (HTA) in general (see for instance http://www.eunethta.eu), but includes many particular aspects that specifically relate to diagnosis and screening.
A clear distinction was made between procedures on the one hand and criteria on the other hand. Procedures relate to the necessary steps and actions to be taken in the frame of assessing health investments. Criteria refer to those parameters that allow assessing to which extent the health investments meet the societal needs in terms of improving health with a focus on effectiveness, cost-effectiveness (=efficiency), and equity. The exact application of criteria and the way the criteria are interpreted and weighed may be subject to cultural and other differences and hence may differ from country to country.
The specific challenge of conducting HTA of diagnostics compared with pharmaceuticals was well recognized by international stakeholders. Three potential types of benefits of the new tool for patients and populations were suggested:
In addition, potential benefits in terms of improvement of current decision-making processes were identified.
The tool could be used as an example /pilot case-study by EUNEHTA and/or the Public Health Genomics European Network PHGEN. Future research is needed to find out to which extent the toolkit could be implemented at any national level and which specific competence/resources are needed for local HTA agencies / decision makers to apply the toolkit.