Health economic evaluations
TLV’s evaluation focus on the methods of using medical devices and not on the products themselves. These evaluations include a health economic evaluation, ethical and legal aspects, as well as organisational and economic consequences.
Economic evaluations are used to compare long term consequences between methods of health care treatments. Results of the economic analysis are calculated as cost per quality adjusted life year (QALY) gained which can be used to describe the cost effectiveness of one treatment in comparison to another. The main aspects considered are effects on quality of life, life years gained (mortality, expected life years), and costs (treatment, health care and social care). In keeping with a societal perspective, TLV aims to include relevant effects and costs outside of the health care sector.
Ethical and legal aspects
Ethical aspects considered in the HTA’s of medical devices are based on the ethical platform for prioritizing health care in accordance with the Health and Medical Services Act (1982:763). The ethical platform consists of three principals, the human dignity principle, the needs and solidarity principle and the cost effectiveness principle.
TLV’s assessments of medical devices are designed to aid region councils in making decisions. Region councils have a high level of autonomy in organizing health care services. In keeping with Swedish law, TLV’s assessments are not decisions or in any way binding.
Organisational and economic consequences
The organisational and economic consequences take into consideration the implementation of a treatment method. This includes education of healthcare professionals, effects on healthcare processes, budget effects, as well as the need for follow up and evaluation.
- Last updated
- 28 October 2022