The need for a national system to evaluate medical technologies other than pharmaceuticals is being considered. Several proposals advocate establishing a type of “Treatment Benefits Board”. To highlight problems and analyse the conditions for national assessments in this context, the National Board of Health and Welfare, the Medical Products Agency, the Swedish Council on Technology Assessment in Health Care (SBU), and the Dental and Pharmaceutical Benefits Agency (TLV) jointly appointed the Centre for Medical Technology Assessment (CMT) at Linköping University to conduct a preliminary study. The preliminary study should provide a foundation for the agencies to decide whether or not the issue needs to be investigated further.
The preliminary study aims to develop background information concerning how Sweden and other countries currently assess, prioritise, and implement decisions involving new nonpharmaceutical health technologies. The basic questions addressed are:
- How can nonpharmaceutical technologies be defined and categorised for the purpose of setting parameters for an approval process?
- How is the current process of assessment, prioritisation, and approval in Sweden structured, focusing on SBU, the Medical Products Agency, the National Board of Health and Welfare, and TLV?
- How have other countries organised their systems for assessment, prioritisation, and approval of nonpharmaceutical technologies?
Within the framework of the project it was not possible to conduct detailed, onsite studies of the healthcare systems in other countries. Hence, we relied on descriptions of other countries’ systems as reported in scientific articles, reports, and official documents available from various organisations and other sources via the Internet. In some instances the information was complemented by interviewing key individuals. The same applies to the descriptions of Swedish agencies. Information concerning the prevalence of various technologies was collected from official reports/reviews and registry data. We present information from six countries where we found sufficient information to preliminarily answer the questions we formulated in advance. The countries are Australia, New Zealand, England, Spain, Italy, Canada, and the USA.
We draw the following conclusions from the preliminary study: It is relatively complicated to define nonpharmaceutical technologies and delineate the technologies that potentially could be subject to regulation. Our practical attempts to describe the technologies that SBU Alert has assessed show that:
surgical and medical interventions dominate, but a relatively high number of screening programmes have also been assessed;
- medical equipment and pharmaceuticals are the predominant input factors. Active implants and biological products are also relatively common. Assistive devices and dental products are seldom considered to be primary input factors;
- most technologies are used primarily for treatment purposes. Diagnostic technologies are also relatively common.
By removing pharmaceuticals from the equation and combining interventions and input factors, SBU Alert arrived at 18 different categories of health technologies that it assesses. The predominant combination is surgical intervention and biomedical equipment. This is followed by surgical intervention and insertion of active implants. In the report, we propose a way to define and classify technologies that we found to be appropriate for the purpose. This does not exclude pharmaceuticals. Rather, pharmaceuticals are included as one input factor among others.
Another aim was to produce background information describing how Sweden and other countries currently assess, prioritise, and approve new nonpharmaceutical technologies. We identified several key components that we believe are worth considering in designing a national system for assessing, prioritising, and approving new nonpharmaceutical health technologies. These components are:
- Organisational level – At what organisational level should the approval of nonpharmaceutical health technologies take place?
- Scope – Should an all-inclusive or selective approach be taken towards inclusion/selection of health technologies for assessment?
- Base package – Should there be a basic list showing what is financed with public funds, or is it sufficient to present only new decisions on the margin?
- Diversity of actors – Should a single actor, or many actors, be responsible for assessment, prioritisation, and decisions regarding financing?
- Fact producer – Who would be most appropriate to manage the factual information base?
- Transparency – How transparent should one be in presenting the decisionmaking process and its results?
- Political involvement – How politically independent should the decisions be?
- Budgetary responsibility – Should the unit that recommends or decides on approval have a budgetary responsibility?
- New and old – Should the decisions apply both to introducing new technology and phasing out old technology?
- Fundamental values – Should there be an explicit set of fundamental values for prioritisation, and how should it be formulated?
- Appeals – Should there be a mechanism to appeal decisions?
To summarise, we see a trend in other countries towards an increasing level of assessment and prioritisation in decisions regarding the introduction of nonpharmaceutical health technologies. Our preliminary impression is that nearly every system that we studied continues to develop and remains “a work in progress”. For instance, in Australia and New Zealand official inquiries are under way to suggest or present proposals for improvement.
Our studies of systems in different countries, although limited, indicate there is no perfect system to copy directly. The way in which the various systems are organised is somewhat related to how health care is organised in the respective countries and how many resources they have decided to dedicate to this purpose. The results from our preliminary study show, however, that several countries have more experience in “approving” nonpharmaceutical-based technologies than what we have in Sweden. The most interesting countries are England, New Zealand, Canada, and Australia. Spain could also be of interest. Hence, there is good reason to consider what might be the best way to analyse these countries’ systems in detail and complement this information with data from other nations that we were unable to include in the preliminary study, e.g. the Netherlands and Israel.
To more rigorously analyse other systems, if this project is continued, investigators should probably start from one or more models for a Swedish mechanism. To arrive at one or more tentative models in this context, the county councils should be involved in the project. The format could be a workshop that engages representatives from public agencies, county councils, and professional associations, where they jointly outline conceivable models that could then be analysed and discussed in light of the experiences of other nations.