From: Decision-making criteria for medicine reimbursement in Slovenia: an expert panel discussion
Domain | Domain content and attributes | Sources† |
---|---|---|
1 Disease impact, Health problem | Disease severity; disease determinants; disease burden; current management of the condition; quality of care; public health interest | EUnetHTA, EVIDEM framework, Guindo et al. 2012, Slovenian criteria medicines and other health technologies |
2 Population and healthcare priorities | Target population; population effect; individual effect; size of population affected by disease; vulnerable and needy populations; public health interest; mission and mandate of the healthcare system | EUnetHTA, EVIDEM framework, Guindo et al. 2012, Slovenian criteria medicines and other health technologies |
3 Ethical aspect and social aspect | Priorities, respect for persons, justice, ethics, equity, solidarity; patient autonomy; legislation; access to medicines; ethical consequences of health technology assessment; patient and social group perspectives; population priorities; communicational aspects; need for the treatment; patient initiatives | EUnetHTA, Guindo et al. 2012, Slovenian criteria for medicines |
4 Medicine description, characteristics and therapeutic context | Type of medical service; features of the medicine and its regulatory status; investments, tools, training and information required to use the technology; treatment alternatives; need for the treatment; clinical guidelines and practices; pre-existing use of the medicine | EUnetHTA, EVIDEM framework, Guindo et al. 2012, Slovenian criteria medicines and other health technologies |
5 Efficacy and Health Benefit | Clinical effectiveness; mortality and morbidity; health-related quality of life; benefit-harm balance; patient-reported outcomes; improvement of patient reported outcomes, convenience and adherence | EUnetHTA, EVIDEM framework, Guindo et al. 2012, Slovenian criteria medicines and other health technologies |
6 Safety | patient safety; occupational safety; improvement of safety and tolerability; safety risk management | EUnetHTA, EVIDEM framework, Guindo et al. 2012, Slovenian criteria medicines and other health technologies |
7 Relevance of evidence | Quality of evidence (research ethics, completeness and consistency of reporting, validity); evidence uncertainty (available evidence and the power of evidence) | EVIDEM framework, Guindo et al. 2012, Slovenian criteria medicines and other health technologies |
8 Economic aspect | Costs and economic evaluation of the medicine (CEA, CUA, BIA); characterizing data uncertainty and heterogeneity; validity of economic models; opportunity costs; value of a medicine | EUnetHTA, EVIDEM framework, Guindo et al. 2012, Slovenian criteria medicines and other health technologies |
9 Organizational and legal aspects, medicine implementation | Organizational requirements and capacity to implement; healthcare system structure; management; barriers and acceptability; medicine flexibility, integration and system efficiency; patient autonomy and privacy; equity in healthcare; authorization and safety; ownership and liability; market regulation | EUnetHTA, Guindo et al. 2012, Slovenian criteria medicines and other health technologies |