Table 6.

Comparison of key factors considered during committee deliberations

Country	Centralized reimbursement review/decision-making body (role)	Clinical need			Clinical benefit/value*				Cost-benefit ratio (cost-effectiveness; efficiency; “value for money”)†	Impact on health resources/affordability (budget impact)	Innovativeness	Other
		Disease burden (severity and number of patients)	Availability of alternatives	Place of technology in care pathway/strategy	Safety (risk–benefit ratio; harm–benefit ratio)	Efficacy/effectiveness	Side effects	Acceptability (tolerance, convenience)
Austria	Association of Austrian Social Security Institutions (decisions)55 Pharmaceutical Evaluation Board (recommendations)56	Yes55	Yes58	Not specified	Not specified	Yes55	Not specified	Not specified	Yes (“pharmacoeconomic evidence”)58	Yes55	Yes50	Price in other European Union countries58
Belgium	Ministry of Health and Social Affairs (decisions) Drug Reimbursement Committee (recommendations)9,60	Yes11,17	Yes21	Not specified	Yes9	Yes (across patient subgroups)9	Yes9	Yes11,17	Yes11,17	Yes11,17	Yes35	Feasibility of implementation11,17 Market price11,17 Social needs11,17,21
Czech Republic	State Institute for Drug Control (decisions)65,176	Yes84	Yes84	Not specified	Yes84	Yes84	Not specified	Yes66	Yes84	Yes84	Not specified	Clinical practice guidelines138 Public interest35
Denmark	Danish Medicines Agency (decisions)68,69,121 Reimbursement Committee (recommendations)68,121	Not specified	Not specified	Not specified	Yes21,68	Yes (across patient subgroups)21,68	Yes21,68	Not specified	Yes21,68	Not specified	Not specified	Reasonableness of price relative to therapeutic value21,68
Estonia	Ministry of Social Affairs (decisions)72 Pharmaceuticals Committee (recommendations)72	Yes84	Yes84	Not specified	Not specified	Yes84	Not specified	Not specified	Yes84	Yes84	Not specified	“Cost efficiency”§140
Finland	Pharmaceuticals Pricing Board (decisions)74,76,77 Pharmaceuticals Pricing Board Expert Group (recommendations)75	Yes181	Yes181	Not specified	Not specified	Yes (across patient subgroups)181	Not specified	Not specified	Yes181	Yes181	Not specified	Research and development35 Level of uncertainty in supporting evidence181 Price in other European Union countries181 Market forecast and share75 Daily cost of treatment per day75
France	Ministry for Health and Social Security (decisions)20,78 French National Authority for Health (recommendations)78	Yes35	Yes35	Yes35	Yes80	Yes35	Yes80	Yes80	Not specified	Yes80	Yes35	Public health impact16,35 Costs relative to current treatment199
Germany	Federal Joint Committee (decisions)24 Institute for Quality and Efficiency in Health Care (recommendations)19,24	Yes19	Yes19	Not specified	Yes19	Yes19	Not specified	Not specified	Yes‡19	Yes113	Yes19
Greece	Transparency Committee in the Reimbursement and Medicinal Products (makes decisions)85	Yes186	Yes186	Not specified	Yes186	Yes186	Not specified	Not specified	Yes (“pharmacoeconomic effectiveness”)186	Not specified	Not specified	Daily cost of treatment186 Reimbursement status in other European Union countries186
Hungary	Ministers of Health and Finance National Health Insurance Fund Administration (recommendations)88	Yes186	Yes84	Not specified	Not specified	Yes84	Not specified	Not specified	Yes186	Yes84	Not specified	Equity26
Ireland	Health Service Executive (decisions)91,92,147	Yes125,165	Yes125,165	Not specified	Not specified	Yes125,165	Not specified	Not specified	Yes125,165	Yes125,165	Yes125,165	Level of uncertainty in supporting evidence125 Wider societal costs and benefits165
Italy	Italian Medicines Agency Technical Scientific Committee (decisions)94 Italian Medicines Agency Pricing and Reimbursement Committee (recommendations)95	Yes27	Yes27	Not specified	Yes96	Yes (across patient subgroups)27	Not specified	Yes27	Yes27	Yes27	Yes20	Daily cost of treatment27 “Special medical needs”96 Price in other European Union countries200 Market forecast and share96
Norway	Norwegian Medicines Agency (decisions)98 Department of Pharmacoeconomics (recommendations)98	Yes34	Not specified	Not specified	Yes149	Yes (across patient subgroups)34	Not specified	Not specified	Yes34	Yes34	Not specified	Equity35 “Solidarity”34 “Rationality”34
Poland	Ministry of Health (decisions)99	Yes84	Not specified	Not specified	Yes84	Yes84	Not specified	Not specified	Yes84	Yes84	Not specified
Portugal	Ministry of Health (decisions) INFARMED (recommendations)36,44	Yes36	Yes36	Not specified	Yes36	Yes36	Not specified	Not specified	Yes36	Not specified	Not specified	Equity36 “Universality”36 “Accessibility”36
Scotland	National Health Service Scotland (decisions)30 Scottish Medicines Consortium (recommendations)	Yes104	Yes30	Not specified	Yes104	Yes104	Not specified	Not specified	Yes104	Yes104	Yes30	Whether pharmaceutical reverses rather than stabilizes condition or bridges a gap to curative therapy104 Level of uncertainty in supporting evidence30 Wider societal costs and benefits30
Slovakia	Ministry of Health (decisions) Reimbursement Committee for Medicinal Products (recommendations)105,107,169	Yes106	Yes84	Not specified	Yes106	Yes106	Yes106	Yes106	Yes84,105	Yes84,106	Not specified	Price of other pharmaceuticals within reference category106
Spain	Ministry of Health Directorate General of Pharmacy and Health Products; Inter-Ministerial Pricing Commission (decisions)21,108	Yes132	Yes132	Not specified	Yes10	Yes (across patient subgroups)132	Not specified	Not specified	Not specified	Yes132	Yes108	“Social utility”132 Rationalization of public expenditures on pharmaceuticals132 Specific needs of certain groups of people132 Research and development132 Price in other European Union countries132 Market forecast132
Sweden	Dental and Pharmaceutical Benefits Board Expert Board (decisions)15,109,110	Yes21	Yes109	Not specified	Yes21	Yes (across patient subgroups)15,21	Not specified	Not specified	Yes21	No21	Not specified	Equity35 “Reasonableness of cost from medical, humanitarian, and socio-economic perspective”33 Solidarity21
Switzerland	Swiss Federal Office of Public Health (decisions) Federal Drug Commission (recommendations)113,114	Not specified	Not specified	Not specified	Not specified	Yes108	Not specified	Not specified	Yes (“value for money”)109	Not specified	Yes108	Research and development109
The Netherlands	Ministry of Health, Welfare and Sport (decisions) Dutch Healthcare Insurance Board Committee of the Dutch Healthcare Insurance Board (recommendations)31	Yes35	Yes21	Not specified	Yes35	Yes35,117	Yes35	Yes35	Yes35,117	Yes¥21,201	Yes35	Rarity Feasibility of implementation117 Accessibility Level of uncertainty in supporting evidence115 Individual versus collective responsibility201 Public health impact35
United Kingdom	National Institute for Health and Clinical Excellence (decisions) Technology Appraisals Committee (recommendations)7	Yes202	Yes202	Yes202	Yes202	Yes (across patient subgroups)202	Not specified	Not specified	Yes202	Not specified	Yes35,197	Level of uncertainty in supporting evidence196 Whether technology represents life-extending, end of life treatment37 Wider societal costs and benefits196 Public health impact35,197 Alignment with broad government priorities202 ICERs of already funded programmes13,157
Wales	Ministry for Health and Social Services (decisions) All Wales Medicines Strategy Group (recommendations)120	Yes28	Not specified	Not specified	Not specified	Yes (across patient subgroups)28	Not specified	Not specified	Yes28	Yes174	Yes28	Level of uncertainty in supporting evidence174 Wider societal costs and benefits28 Alignment with broad government priorities28 ICERs of funded programmes28

Notes:

^*In a well-defined population;

^†price proportionate to effect;

^§cost efficiency takes into account costs of treatment per patient, as well as costs of compensatory allowance due to lost income and costs of restoring patients’ capacity to work;

^‡efficiency of resource use within a single therapeutic area relative to existing interventions;

^¥not a formal criterion.