HTA in Slovenia - new developments

• Abstract
• Purpose of health policy or idea
• Characteristics of this policy
• Political and economic background
• Purpose and process analysis
• Expected outcome
• References

Featured in half-yearly report: Health Policy Developments 11

Abstract

Throughout its transition process Slovenia has had systems for delivering healthcare at the forefront of its attention, so health technology assessment, is at an embryonic level in Slovenia. However, medical and pharmaceutical science and technology is constantly developing, and with growing needs in the population particularly in the fields of medical diagnostics, rehabilitation and therapy, there is a rising demand for assessment of introduction of new techologies in health care.

Purpose of health policy or idea

New challenges require not only skilled human resources, better premises and modern equipment, but also additional financial resources, which are limited in the public sector by the gross domestic product and the share for healthcare and health programmes. The discrepancy between the need for new developments in medicine and their funding is constantly growing, so a continuous critical assessment of new methods of medical treatment as they are introduced is very important in Slovenia.

Main points

Main objectives

The main short term objective is the preparation of pharmacoeconomic guidelines for Slovenia as this is the most burning issue. Previous experience with the introduction of replaceable medication and the preparations for full generic drugs availability put a lot of stress on the communication with the broader public community. While there is a lot of work done at different levels and environments on HTA with pharmaceuticals, there are still serious shortcomings in the field of equipment, facilities and, especially, diagnostic and therapeutic procedures. The establishment of a HTA agency at the national level should provide the necessary base for evaluation of these processes which have so far been in the domain of several stakeholders, both public and private.

Type of incentives

The intention of building a national HTA agency stems from the idea that it should be based on non-financial interests and provide scientific and professional evidence of the highest level. So far, a lot of HTA performed was driven by private interests of proposers, mostly pharmaceutical industry, commissioning HTA from private providers. While this is completely legitimate, there is no independent body to assess the findings of such work and to evaluate it against the internationally accepted standards.

Groups affected

Stakeholders, Payers, Providers

Degree of Innovation	traditional		innovative
Degree of Controversy	consensual		highly controversial
Structural or Systemic Impact	marginal		fundamental
Public Visibility	very low		very high
Transferability	strongly system-dependent		system-neutral

The discrepancy between the needs and demands of new tecnologies and possibilities of their funding is constantly growing. Therefore, a critical and continuous assessment of the introduction of new methods of medical treatment is required. The assessment for the suggested changes shall show impacts on the health status of the population, and, among other, efficiency and effectiveness of the utilization of the current and future investments in health care.

Political and economic background

Complies with

EU regulations

In spite of the declarative positions and positive developments in the EU, Slovenia still needs to decide to step in the process.

Change based on an overall national health policy statement

Agencies and programs have been established across the EU in the past decades and Slovenia is lagging behind. The proposal to the MoH of establishing a commission for HTA was successful and the first session of a commission for HTA was called in April.

Purpose and process analysis

Current Process Stages

	Idea	Pilot	Policy Paper	Legislation	Implementation	Evaluation	Change
Implemented in this survey?

Origins of health policy idea

MoH is aware of the necessity of health technology assessment and coordination, so in the near future Slovenia is going to implement the European standards for health technology and it is taking steps towards a standardization and coordination of health technology.

Recently, a much more concrete and decided step was taken by adopting the protocol for proposals of new diagnostics, treatments, procedures and therapies. This protocol is used to standardize proposals submitted to the Health Council, which is the main advisory body to the MoH and which decides on granting consents to programs to be financed through public financing sources (either compulsory health insurance or national budget). The protocol has passed the initial phase of its use and has now been implemented fully for all procedures.

Moreover, a commission for preparation of pharmacoeconomic guidelines was established with a purpose to prepare the guidelines in accordance with the european standards.

Initiators of idea/main actors

• Government

• Providers

• Payers

• Scientific Community

• Private Sector or Industry

Approach of idea

The approach of the idea is described as:
new: Only in 2008, MoH started to take into consideration the standardized guidelines for pharmacoeconomic studies and HTA in general. The commission will prepare the guidelines and discuss the future development and implementation of HTA in Slovenia.

Stakeholder positions

The commission at the MoH consists of main stakeholders, i.e. Health Insurance Institute of Slovenia, Institute of Public Health, Public Agency for Pharmaceuticals, Institute for Economic Analysis in Healthcare, Pharmaceutical Faculty and  a representative of the pharmaceutical industry. The first guidelines will be prepared by end of May 2008.

Actors and positions

Government
Ministry of Health	very supportive		strongly opposed
Providers
National Inst. of Public Health	very supportive		strongly opposed
Public Agency for Medicines and Medical Aids	very supportive		strongly opposed
Payers
Health Insurance Institute of Slovenia	very supportive		strongly opposed
Scientific Community
Faculty of Pharmacy Ljubljana	very supportive		strongly opposed
Private Sector or Industry
Inst. for econ. analyses in health care	very supportive		strongly opposed
Pharmaceutical industry	very supportive		strongly opposed

Influences in policy making and legislation

The commission will suggest an extended mandate to the MoH in order to reach a consensus on preparation of a policy paper.

Legislative outcome

pending

Actors and influence

Government
Ministry of Health	very strong		none
Providers
National Inst. of Public Health	very strong		none
Public Agency for Medicines and Medical Aids	very strong		none
Payers
Health Insurance Institute of Slovenia	very strong		none
Scientific Community
Faculty of Pharmacy Ljubljana	very strong		none
Private Sector or Industry
Inst. for econ. analyses in health care	very strong		none
Pharmaceutical industry	very strong		none

Positions and Influences at a glance

Adoption and implementation

Health Insurance Institute of Slovenia, Institute of Public Health, Public Agency for Pharmaceuticals, Institute for Economic analysis in healthcare, Pharmaceutic Faculty and  a representative of the Pharmaceutic industry are represented in the Commission, which is led by the MoH.

Expected outcome

At this time it is too early to give a statement about the expected outcomes as the commission was only founded at the beginning of April. However, the pharmacoeconomic guidelines under preparation will form the basis for further work in the field of health technology assessment.

Impact of this policy

Quality of Health Care Services	marginal		fundamental
Level of Equity	system less equitable		system more equitable
Cost Efficiency	very low		very high

A structured HTA enables a more cost efficient public spending due to better transparency in the introducition of new thechnologies. Slovenia is working on the possibility to transfer European HTA reports and adapt them to the Slovene health care system.

References

Sources of Information

1. The EU network of HTA agencies: www.eunethta.net
2. WHO meeting report, "Institutionalization of Health Technology Assessment", WHO, 2001
3. Discussion papers at the MoH of Slovenia and with the Health Council 2007-2008.

Author/s and/or contributors to this survey

Eva Turk, Tit Albreht

Eva Turk is a young researcher in health economics and a PhD candidate, interested in health accounts, long-term care costs and planning and health technology assessment.

Suggested citation for this online article

Eva Turk, Tit Albreht. "HTA in Slovenia - new developments". Health Policy Monitor, April 2008. Available at http://www.hpm.org/survey/si/a11/4