. 2011 Aug 30;3:117–186. doi: 10.2147/CEOR.S14407

Table 4.

Comparison of economic evidence requirements

Country	Centralized reimbursement review/decision-making body (role)	Economic analysis						Budget impact analysis		Other economic information
Country		Required	Economic analysis types accepted	Perspective/costs included	Comparator	Sensitivity analysis	Systematic review of economic analysis studies	Required	Costs included	Other economic information
Austria	Association of Austrian Social Security Institutions (decisions)⁵⁵ Pharmaceutical Evaluation Board (recommendations)⁵⁶	Yes for: “innovative products providing substantial therapeutic benefit “where no comparable medical preparation exists”²¹	Any type, but rationale for selection must be provided²¹ Should comply with internationally recognized pharmacoeconomic guidelines²¹	Payer²¹ Costs not specified	Most commonly used alternative²¹	Yes – type not specified²¹	Yes	No information found	N/A	3 year market sales forecast Price in other European Union countries Reimbursement status in other European Union countries⁵⁵
Belgium	Minister of Social Affairs (decisions) Commission on reimbursement of medicines/drug reimbursement committee (recommendations)⁹,⁶⁰	Yes for: Pharmaceuticals with added therapeutic value relative to existing alternatives (Class I)¹¹,¹⁷ Not required for orphan pharmaceuticals⁶²	Cost effectiveness Cost utility Cost benefit not accepted¹¹ Should comply with Belgium pharmacoeconomic guidelines¹⁷	Payer (includes patient copayments and government)¹¹,¹⁷ Direct costs only¹¹,¹⁷	Most commonly used alternative OR Alternative most likely to be replaced If add-on: current treatment without add-on¹⁷ Off-label treatments not acceptable¹¹ Rationale must be provided	Probabilistic¹⁷	Yes¹⁷	Yes¹¹	Direct costs only¹¹,¹⁷	Price Reimbursement status in other European Union countries¹¹,¹⁷
Czech Republic	State Institute for Drug Control (decisions)⁶⁵	Yes⁶⁶	Cost effectiveness¹³⁸	Payer⁶⁶ Direct costs¹³⁸	No information found	Method not specified	No information found	Yes¹³⁸	No information found	No information found
Denmark	Danish Medicines Agency (decisions)⁶⁸,⁶⁹,¹²¹ Reimbursement Committee (recommendations)⁶⁸,¹²¹	No, but often included to justify high price⁶⁸,⁷¹,¹⁶⁰	Cost effectiveness Cost utility⁶⁸ If included, methods should comply with Danish Guidelines for the Socio-economic Analysis of Medicines⁶⁸	Societal (if included) Direct, indirect, and intangible; to be reported separately⁷¹	Most commonly used alternative³⁸	Method not specified, but key parameters associated with uncertainty should be explored³⁸	No information found	Yes³⁸	No information found	Reimbursement status in other European Union countries Estimated consumption (number of patients and utilization)³⁸
Estonia	Ministry of Social Affairs (decisions)⁷² Pharmaceuticals Committee (recommendations)⁷²	Yes⁸⁴,¹³⁹	Cost effectiveness Cost utility Cost minimization rationale for selection must be provided¹³⁹	Payer¹³⁹ May present separate analysis from societal perspective⁸⁴ Direct costs within and outside of the health care system (should be reported separately)¹³⁹	Most commonly used alternative OR Standard care¹³⁹ Rationale must be provided	Method not specified	No information found	No information found	No information found	No information found
Finland	Pharmaceuticals Pricing Board (decisions)⁷³,⁷⁴,⁷⁶ Pharmaceuticals Pricing Board Expert Group (recommendations)⁷⁵	Yes for: Pharmaceuticals considered for reimbursement in one of the special refund categories⁷⁴,⁷⁶	Any type, but rationale for selection must be provided⁷⁶ Methods must comply with Ministry of Social Affairs and Health guidelines⁷⁶	Societal⁷⁶ Direct and indirect costs – presented separately⁷⁶	Alternative most likely to be replaced OR Most commonly used alternative OR Most effective alternative OR Minimum management⁷⁶ Rationale must be provided	Method not specified	Yes⁷⁶	Yes¹⁶¹	No information found	Market sales forecast Reimbursement status in other European Union countries Estimated consumption (number of patients and utilization)¹⁶¹
France	Ministry for Health and Social Security (decisions)²⁰,⁷⁸ French National Authority for Health (recommendations)⁷⁸	Yes for: Multiple technology appraisals of pharmaceuticals²⁰	Any type, but rationale for selection must be provided²² Methods must comply with French economic guidelines²⁰	Varies, but should take the widest possible perspective – rationale for selection must be provided ⁸⁴ Direct costs; may include indirect costs, but must be presented separately²²	Following 3 comparators required: Most commonly used alternative Most recently reimbursed alternative Least expensive alternative¹⁶	Method not specified	Yes for pharmaceuticals²²	Yes²⁰	No information found	Market sales forecast Reimbursement status in other European Union countries Breakdown of costs for manufacturing and distribution²²,¹⁶²
Germany	Federal Joint Committee (decisions)¹⁹ Institute for Quality and Efficiency in Health Care (recommendations)¹⁹,²⁴,¹⁴⁴	Yes for: Technologies where alternative treatment exists⁸,¹⁸	Any one of: Cost effectiveness Cost utility Cost minimization/cost comparison¹⁸ Efficiency frontier analysis¹²	Payer Patient⁸³ Direct and indirect costs⁸	Most commonly used alternative OR Most effective alternative OR Minimum standard care⁸	One-way and multi-way (performed as probabilistic)²⁴	Yes⁸⁴	Yes, except when no alternative exists¹⁸	No information found	No information found
Greece	Transparency Committee in the Reimbursement and Medicinal Products (makes decisions)⁸⁵,¹⁶⁰	Yes for: Pharmaceuticals eligible for reference price system⁸⁵	No information found	No information found	No information found	No information found	No information found	Yes⁸⁵	No information found	Cost of daily treatment Reimbursement status in other European Union countries⁸⁵
Hungary	Ministers of Health and Finance (decisions) National Health Insurance Fund Administration (recommendations)⁸⁶,⁹⁰,¹⁰²	Yes⁸⁴	Preference for: Cost effectiveness Cost utility¹⁶³	Payer Societal (also recommended) Report results from each perspective separately¹⁶³	Standard care¹⁶³	Yes, but type not specified¹⁶³	No information found	Yes⁸⁴	If payer perspective, include direct costs only If societal perspective, include indirect costs (productivity)¹⁶³	No information found
Ireland	Health Service Executive (decisions)⁹¹,⁹²	Yes¹⁴⁶	Preference for: Cost utility¹⁰ Any one of the following may be acceptable if rationale is provided: Cost benefit Cost effectiveness Cost minimization/cost comparison¹⁴⁷,¹⁶⁵ Methods must comply with Irish Healthcare Technology Assessment Guidelines¹⁴⁶	Payer¹⁴⁷ Direct costs only¹⁴⁷	Standard care¹²⁵	Probabilistic and deterministic¹²⁵	No information found	Yes	Direct costs only⁹¹,¹⁴⁷	No information found
Italy	Italian Medicines Agency Technical Scientific Committee (decisions)⁹⁴ Italian Medicines Agency Pricing and Reimbursement Committee (recommendations)⁹⁵	Yes for: Pharmaceuticals with a favorable “risk/benefit profile”⁹⁷,¹⁴⁸	Preference for: Cost utility Cost effectiveness¹⁴⁸ Methods must comply with Italian pharmacoeconomic guidelines¹⁴⁸	Societal AND Payer¹⁴⁸ Direct and indirect costs¹⁴⁸	Most commonly used alternative¹⁴⁸	Methods not specified, but should involve multi-way analysis¹⁴⁸	No information found	Yes¹⁴⁸	No information found	Cost of treatment compared to those in same therapeutic class Market sales forecast Price in other European Union countries Reimbursement status in other European Union countries Estimated consumption (number of patients and utilization) Industrial implications⁹⁷
Norway	Norwegian Medicines Agency (decisions)⁹⁸ Department of Pharmaco economics (recommendations)⁹⁸	Yes for: Pharmaceuticals with added therapeutic value relative to existing alternatives³⁴	Preference for: Cost-value analysis¹⁵⁰ Any one of the following may be acceptable if rationale is provided: Cost benefit Cost effectiveness Cost utility Cost consequence Cost minimization/cost comparison³⁴ Methods must comply with Norwegian pharmacoeconomic guidelines³⁴	Societal AND Payer¹⁵⁰	Most commonly used alternative OR Least expensive alternative¹⁵⁰	Probabilistic preferred¹⁵⁰	No information found	Yes¹⁴⁹ Aggregate added expense to health service for first 5 years¹⁴⁹	No information found	Market sales forecast Price in other European Union countries Reimbursement status in other European Union countries Estimated consumption (number of patients and utilization)¹⁴⁹,¹⁵⁰
Poland	Ministry of Health (decisions)⁹⁹,¹⁶⁶	Yes for: Pharmaceuticals with added therapeutic value relative to existing alternatives⁸⁴	Cost effectiveness Cost utility⁸⁴	Societal AND Payer¹⁶⁷	Alternative most likely to be replaced OR Most commonly used alternative OR Least expensive alternative OR Standard care compliant with clinical practice guidelines¹⁵¹	Methods not specified	No information found	Yes⁸⁴	No information found	No information found
Portugal	Ministry of Health (decisions) INFARMED (recommendations)⁶⁴,¹⁶⁰	Yes⁴⁴,¹⁶⁰	Any one of : Cost benefit Cost effectiveness Cost utility Cost minimization/cost comparison; rationale for selection must be provided¹⁰¹	Societal¹⁰¹ Direct costs Indirect costs: only those related to lost productivity¹⁰¹	Most commonly used alternative Standard care¹⁰¹	Methods not specified	No information found	No¹⁰¹	N/A	No information found
Scotland	National Health Service Scotland (decisions)³⁰ Scottish Medicines Consortium (recommendations)	Yes¹⁶⁸	Any one of : Cost benefit Cost effectiveness Cost utility Cost minimization/cost comparison; rationale for selection must be provided¹⁶⁸ Methods must comply with SMC economic guidelines¹⁶⁸	Payer³⁰	Alternative most likely to be replaced OR Most commonly used alternative³⁰	Probabilistic¹⁶⁸	No information found	Yes³⁰	No information found	National Health Service resource implications³⁰
Slovakia	Ministry of Health (decisions) Reimbursement Committee for Medicinal Products (recommendations)¹⁰⁵,¹⁰⁷	Yes¹⁰⁵,¹⁰⁶	Cost effectiveness Cost utility (if pharmaceutical has impact on quality of life) Cost minimization/cost comparison Cost benefit not accepted¹⁶⁹ Methods should comply with national economic guidelines¹⁷⁰	Payer¹⁶⁹ Direct costs¹⁶⁹	Alternative most likely to be replaced If add-on: current treatment without add-on¹⁵²	Probabilistic¹⁰⁶,¹⁵²	Yes¹⁵²	Yes Estimated over first 5 years⁸⁴	No information found	No information found
Spain	Ministry of Health Directorate General of Pharmacy and Health Products; Inter-Ministerial Pricing Commission (decisions)²¹,¹⁰⁸,¹⁷¹	No²¹	Preference for: Cost effectiveness Cost utility¹⁰,²¹ Any one of the following may be acceptable if rationale is provided: Cost benefit Cost effectiveness Cost utility Cost consequence Cost minimization/cost comparison¹⁰	Societal AND Payer¹⁰ Presented separately	Most commonly used alternative Standard care¹⁰ Rationale must be provided	Multi-way¹⁰	No information found	Yes, comparing “corresponding products”¹⁰	No information found	No information found
Sweden	Dental and Pharmaceutical Benefits Board (decisions)¹⁵,¹⁰⁹	Yes, if requested²¹	Any one of: Cost effectiveness Cost utility Cost minimization/cost comparison; rationale for selection must be provided¹⁵ Methods must comply with Swedish economic guidelines¹⁵	Societal Direct costs Indirect costs: lost productivity and lost time for patients and carers¹⁴,¹⁵	Most commonly used alternative¹⁵	Not specified	No information found			Estimated average duration of use Estimated consumption (number of patients and utilization) Estimated cost of use per day¹⁵
Switzerland	Swiss Federal Office of Public Health (decisions) Federal Drug Commission (recommendations)¹¹³,¹¹⁴	No, but should be included if available¹¹⁵,¹⁷²	No information found	No information found	No information found	No information found	No information found	Yes¹¹⁵,¹⁷²	No information found	Price in other European Union countries Reimbursement status in other European Union countries Estimated cost of use per day¹¹⁵,¹⁷²
The Netherlands	Ministry of Health, Welfare and Sport (decisions) Medicinal Products Reimbursement Committee of the Dutch Healthcare Insurance Board (recommendations)¹¹⁶	Yes for pharmaceuticals with added therapeutic value (Annex 1B), except for orphan pharmaceuticals with small budget impact or absence of active alternative¹⁵⁴	Cost effectiveness Cost utility Methods must comply with Dutch Healthcare Insurance Board economic guidelines³⁶,⁸⁴,¹⁷³	Societal Direct costs¹⁵⁴ Indirect costs may be included but must be reported separately¹⁵⁴	Most commonly used alternative OR Most relevant reimbursed alternative⁸⁴,¹⁷³	One-way, multi-way, and probabilistic³⁵	No information found	Yes¹⁵⁴	No information found	Anticipated substitution effects Price Estimated consumption (number of patients and utilization)¹⁵⁴
United Kingdom	National Institute for Health and Clinical Excellence (decisions) Technology Appraisals Committee (recommendations)⁷	Yes⁷	Cost effectiveness Cost utility Methods must comply with National Institute for Health and Clinical Excellence economic guidelines¹³,¹⁵⁷	Payer¹³,¹⁵⁷ Direct and indirect costs to National Health Service and Personal Social Services	Most commonly used alternative OR Best practice alternative¹³,¹⁵⁷	Probabilistic¹⁵⁷	Yes¹³,¹⁵⁷	Yes¹³,¹⁵⁷	No information found	National Health Service resource implications¹³,¹⁵⁷
Wales	Ministry for Health and Social Services (decisions) All Wales Medicines Strategy Group (recommendations)²⁸	Yes¹⁷⁴	Any one of: Cost effectiveness Cost utility Cost minimization/cost comparison; rationale for selection must be provided²⁸,¹⁷⁴ Methods must comply with economic guidelines²⁸,¹⁷⁴	Societal²⁸	Most commonly used alternative²⁸	Probabilistic²⁸	Yes²⁸	Yes²⁸,¹⁷⁴	No information found	National Health Service resource implications²⁸,¹⁷⁴