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Table 1 Decision-making criteria domains used in the guided discussion with the expert panel

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
  1. Legend: † EUnetHTA - European network for Health Technology Assessment [20]; EVIDEM framework - framework Evidence in Decision-Making [21]; Slovenian criteria set for reimbursement decision-making of medicines [3]; Slovenian criteria set for the assessment of other health technologies [4]; Guindo et al. 2012 [22]