In its 25 years of independence, many changes in political and economic systems have occurred and Slovenia managed to achieve a status of high income and developed country in conjunction with being a member of European Union since 2004 and a member of European Monetary Union since 2007. According to the World Bank (1), Slovenia ranked 48th with a gross national product of PPP$ 29,920 in 2014. The average life expectancy reached 77.2 years for men and 83.1 years for women in 2013 (compared with 77.5 years for men and 84.2 years for women in the EU as a whole) (2). Slovenia has one of the lowest fertility rates in all EU Member States: the total fertility rate was 1.58 births per woman in 2014, far below the replacement level (3). The population aged 65+ represented 17.3% of the total population in 2014; in 2060, they are going to account for almost one-third (29.4%) of total population (2). This raises concerns over the incidence of chronic diseases and their social implications.
Slovenia has a mandatory public health insurance system that is financed through contributions by employers and employees. The coverage of the population is universal, less than 1% of the population is uninsured (mostly due to current changes in status or due to unclear residence situation). Opting out of compulsory coverage is not permitted. Total health expenditure in Slovenia amounted to €3.3 billion or 8.32% of gross domestic product (GDP) in 2016. Public expenditure amounted to 6.02% of GDP (92% of public expenditure is compulsory health insurance) and 2.30% is private expenditure. Private expenditure is composed of voluntary health insurance (VHI) and out of pocket payments, each representing half of private expenditures (4). The VHI consists mainly of complementary health insurance, which covers co-payments levied on healthcare services offered in the basic benefits package
Health Insurance Institute of Slovenia (HIIS) is the only provider of compulsory healthcare insurance in Slovenia. Compulsory health insurance provides full coverage for defined health services, all other services involve cost-sharing through co-payments ranging from 5% to 95% of the price of healthcare services. The processes of introducing and reimbursing new health technologies into the health system are unified neither in process nor in criteria and depend on the type of healthcare technology. Pharmaceuticals are assessed by HIIS and its Advisory body Pharmaceutical Reimbursement Commission, which follows Rules on inclusion of medicines in the list (5). Medical devices are also introduced through HIIS, but based on lowest price criteria only. All other healthcare technologies are introduced through Health Council in Ministry of Health (MoH), following Procedures on handling the applications for new healthcare programs (6).
METHODS
A review of the existing scientific literature and legal documents was used to describe the current status of implementation of health technology assessment (HTA) and for identifying future challenges in the HTA in Slovenia. To assess the current status of HTA implementation in Slovenia, a scorecard developed by Kalo et al. (Reference Kalo, Gheorghe, Huić, Csanadi and Kristensen7) was used. The scorecard was developed as a tool for assessment of HTA implementation phase across countries and is based on the review of scientific literature on HTA implementation practices in CEE as well as on experiences by the authors (Reference Kalo, Gheorghe, Huić, Csanadi and Kristensen7). All eight key elements in the roadmap were used to scrutinize the HTA implementation: capacity building; HTA funding; HTA legislation and organizational structure; the scope of HTA implementation; decision criteria; quality, timelines, and transparency of HTA implementation; use of local data; and international collaboration.
IMPLEMENTATION OF HTA IN SLOVENIA
HTA is not formally or systematically established in Slovenia to aid the introduction of all new healthcare technologies into the publicly financed health insurance system. Health technologies are usually introduced arbitrarily, and quite a large degree of freedom is given to providers in choosing ways of service provision that can be reimbursed by insurance (Reference Albreht, Brinovec and Jošar8). The most regulated field with regard to HTA is pharmaceuticals, which are introduced into public financing through the Pharmaceutical Reimbursement Committee, an advisory body to HIIS. Its recommendations to HIIS are formed following the procedures defined in the Rules on inclusion of medicines in the list (5).
Much less-regulated and vague healthcare technologies regarding HTA are the medical procedures (diagnostic and therapeutic) and other technologies such as organizational change-based technologies (e.g., telemedicine, informatization), vaccinations, screening and other preventive and curative programs. These are assessed by the Health Council, the highest advisory body to MoH, following Procedures on handling the applications for new healthcare programs (6). A specific group of healthcare technologies, assessed on the basis of price competition, is medical devices.
Building on eight key elements from the roadmap for the assessment of current status of HTA implementation, we discuss the current situation of Slovenia regarding HTA.
1. Capacity Building
Although significant efforts have been given already to the establishment of more standardized approaches to HTA by creating guidelines and standard procedures (5;6), much fewer efforts were directed into the capacity building at the national level. There are no specific educational courses in the universities that would tackle HTA. As relevant experts who assess scientific evidence in the HTA processes are often employed at the universities, we can see that there is an unused potential to set up HTA educational courses.
Furthermore, more specialized training and workshops for researchers and HTA doers have been offered in 2016 by the ISPOR regional chapter (9). The interest has been large, mostly among HTA doers. The Slovenian Health Economists Association is active in the educational field of healthcare financing and budget allocating issues, but has not gotten involved in HTA field; nevertheless, it remains as a potential knowledge disseminator in the area (10).
Unfortunately, appraisal bodies do not have sufficient knowledge and practice in the area. The appraisals are performed ad-hoc, either by the Health or Pharmaceutical Reimbursement Commission. The members of both bodies are non-HTA professionals and are involved in appraisals based on the work positions they otherwise hold. This undermines the mutual learning process with the HTA assessors: systematic capacity building, including using the opportunities for HTA training abroad, is needed to achieve a comprehensive HTA system.
2. HTA Funding
No special budget funding for HTA is available in Slovenia. HIIS charges a fee up to 2,000 EUR fee for pharmaceutical submissions to be assessed in the application procedure for reimbursement (5). Sporadic HTA assessments prepared by small private consulting companies are financed by pharmaceutical companies. No prioritizing processes are in place, and no systematic funding by government for HTA research or establishment of an HTA system at the national level has been available.
3. HTA Legislation and Organizational Structure
In Slovenia, there is no national regulatory HTA framework or nationally established HTA mechanism for introducing new health technologies in the system of public financing. In the same context, there is no established mechanism to determine disinvestments. The need to formalize HTA for all health technologies is known and various initiatives have been present in the system for a decade to introduce it. The National Institute of Public Health was tasked with the preparation of the expert groundwork for the assessment of health technologies in the context of the European HTA network foreseen by the Directive 2011/24/EU, but not much progress in the area has been observed. HTAs, except for pharmaceuticals, are currently undertaken in the ad hoc and unsystematic way. The need to establish a national HTA system has been emphasized by Slovenian representatives in EUnetHTA network and also taken up again in the newest National Health Plan, which was adopted by the Parliament in December 2015 (11).
However, the absence of the HTA Act does not mean that sublaws do not tackle the HTA field. HIIS is by far the most progressive in HTA principles implementation. Pharmaceuticals are systematically evaluated once marketing authorization has been granted to be placed on the positive or intermediate list. Rules on inclusion of medicines in the list (5) define the types of the analysis, timelines, and decision criteria, that need to be followed in the assessment of pharmaceuticals. Manufacturers or other applicants need to support their claims for reimbursement by proving the technology to be clinically effective, safe, and cost-effective. The supportive analysis should be adapted to the Slovenian setting and based on Slovenian data as much as possible. In cases when the submissions are not aimed to a new drug or new therapeutic indication (e.g., modification of packaging, generic drugs, Gaelic products), the submission file is simplified.
Other healthcare technologies, as shown in Figure 1, are introduced through Health Council, where the recommendation are based on the criteria defined in Procedures on handling the applications for new healthcare programs (6). The protocol consists of several questions on the technology, its safety, target population, clinical effectiveness, costs, and organizational issues.
The HTA process in Slovenia. The process of HTA shows that the decisions on financing of pharmaceuticals from public funds are taken by the Health Insurance Institute of Slovenia, while decisions for other healthcare technologies (except for medicals devices) are taken by the MoH following recommendations by the Health Council.
4. Scope of HTA Implementation
Although HTA is not defined in the legislation and the decision-making process is carried out through various channels depending on the type of the health technology, most of the new technologies go through some form of scrutiny before their inclusion in the system of public financing (5;6). The introduction of pharmaceuticals into public financing follows a formalized assessment, where the Pharmaceutical Reimbursement Commission is summoned for appraisal by the HIIS (usually on a monthly basis) to provide relevant recommendations, while the final decision for inclusion rests with the HIIS.
The assessments of pharmaceuticals are usually prepared by the pharmaceutical companies and only occasionally the independent assessment is submitted. Medical devices and other healthcare technologies do not get a proper assessment phase. The introduction of medical devices into public financing is based exclusively on price negotiations between manufacturers and HIIS, meaning that cost is the only real criterion of decision making. A special protocol to evaluate proposals for the funding of new diagnostics, treatments, procedures, and therapies was adopted by the Government and is used by Health Council who issues recommendations on these healthcare technologies (6).
5. Decision Criteria
The recommendations of the Pharmaceutical Reimbursement Commission are based on the information in the submission files. Decisions are based on the presented relative therapeutic value and incremental cost-effectiveness ratio of the drug, expressed in marginal costs per quality-adjusted life-year (QALY); the threshold for the acceptance of the cost effectiveness of the pharmaceuticals is set to 25,000 EUR (12). The Pharmaceutical Reimbursement Commission members are physicians and clinical pharmacists as well as other experts with systemic knowledge in the field of drugs. Their recommendations are independent, and they serve as consulting body to HIIS (5).
HTA form for procedures or health programs is less defined and includes the description of the technology, current and expected use, safety, clinical effectiveness, and costs. An HTA form is filled out by manufacturers or other applicants. These health technologies are appraised by Health Council (6).
6. Quality, Timelines, and Transparency
Other than the aforementioned guidelines and forms (5;6), no further methodological guidelines or checklists have been published. Timelines for recommendations by Pharmaceutical Reimbursement Commission are defined to 90 days, but can in certain circumstances be extended to up to 180 days since the submission of complete drug file (5).
Both Committees publish their recommendations on their respective Web pages (in a form of changes in the list of drugs and in a form of the recommendation taken at Health Council). The critical assessments as well as appraisal are strictly confidential and are not published. In the process, there are possibilities for committees to have the consultation with the manufacturer or clinicians; however, consultation with patients are not foreseen. There are no specific guidelines on quality checks in the preparation of HTAs.
7. Local Data
The use of local data in HTA analysis is very limited, especially in submissions for health technologies other than pharmaceuticals. They are limited to the epidemiological data mostly. In HTA analyses for pharmaceuticals, local data on costs are used; however, limited access to patient database and registries delay the HTA research. Estimating the number of patients in certain disease areas may be difficult due to a noncentralized information technology system, which does not connect local data yet to the central level. Often, the average costs (prices estimated by HIIS) are used instead of realistic costs for the budget impact and economic analysis within HTA processes.
8. International Collaboration
Despite the lack of systematic HTA activities in Slovenia, the institutions have been very active in HTA field in the international arena. The National Institute of Public Health and The Institute for Economic Research, which is a public institute active in health economics, have been involved in the European collaboration platform EUnetHTA since 2010 (Institute for Economic Research between 2012 and 2015), and researchers have cooperated in numerous activities at European level. International collaboration has been one of the most important drivers to keep the HTA activities developing in Slovenia. Within EUnetHTA JA3, Slovenia is represented by the MoH.
FUTURE CHALLENGES
A debate on a more systematic approach to HTA on the national level has been ongoing for almost a decade in Slovenia. Numerous scattered HTA activities cannot ensure common methodological background for conducting HTA. Although ad hoc developments in the HTA field have been positive, they still remain scattered, and further steps to ensure higher quality of research, sustainable development of human resources, systematic approach to all technologies, and standard rules cannot grow out of scattered fields of knowledge. To build on them, they need to be linked together, coordinated according to the national guidelines, quality standards, and national priorities.
To expand the knowledge and human resource capacities in the area, it is important to start building on the existing knowledge in the universities and set up more HTA courses for students and afternoon courses and training for policy makers and HTA doers. Other organizations, such as ISPOR and Slovenian Health Economists Association, can be used for further promotion of understanding and meaning of HTA. As a coordinating body to link together all the various bodies in HTA scene in Slovenia, a smart form of HTA network needs to be established in the form of coordination and offering support for existing actors with preparing HTA legislation, guidelines (e.g., on use of local data, on inclusion of stakeholders, on methodology of preparing HTA analysis), international collaboration, and setting of priorities. The transition into formalized and systematic evaluation of health technologies needs to be sensitive and should build on the existing fragmented HTA elements; establishment of a new HTA agency that would need to build its capacities from scratch and find its own new place in the already existing, but a fragmented system is hardly sensible anymore. Any such development toward a systematic approach, transparency, and comprehensiveness will require firm support and commitment of the government.
However, governmental support should not only be visible in the legislative and organizational setup of HTA, but also in the provision of independent HTA funding that needs to be ensured for functioning of the HTA coordinating office as well as for independent work of the bodies involved in the appraisal phase. The decision-making processes need to be transparent, and critical evaluations and conclusions should be publicly available to the interested audience.
CONCLUSION
During the past decade, the development of HTA in Slovenia was sporadic and fragmented. No common methodological guidelines were developed for introducing various healthcare technologies into the system of public financing. The procedures for new applicants were defined but lack the methodological background and common rules for all health technologies. Human capacities and knowledge are not widespread enough, and HTA does lack understanding and support of health policy. HTA legislation has not been passed, and there is a lack of coordination of the activities.
Several challenges lie on the path of HTA development in Slovenia. These include defining a smart approach toward coordination of fragmented HTA activities, systematic capacity building, implementing systematic priority setting and HTA process on defined methodological guidelines for all health technologies, preparation of HTA legislation that will establish its place and use in the health policy, improved understanding of the need for HTA and access to local data for HTA doers, inclusion of various stakeholders in the HTA process as well as a higher transparency in decision making.
CONFLICTS OF INTEREST
The author reports no conflicts of interest.
