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Country/Region: Spain

Published PE Recommendations
Spanish Recommendations on Economic Evaluation of Health Technologies (2010) (Spanish Version 2009)
PDF in English; PDF in Spanish

Published PE Recommendations Source:

Additional Information:
1. Julio Lo´pez-Bastida, Juan Oliva, Fernando Anton˜anzas, Anna Garci´a-Alte´s, Ramo´n Gisbert, Javier Mar, Jaume Puig-Junoy. Spanish Recommendations on Economic Evaluation of Health Technologies. European Journal of Health Economics. 2010 Oct;11(5):513-20. Epub 2010 Apr 20.
2. Rovira J, Antoñanzas F. Economic Analysis of Health Technologies and Programmes: A Spanish Proposal for Methodological Standardization. Pharmacoeconomics. 1995 Sep;8(3):245-52."

Last Webpage Update: Thursday, April 12, 2018

Published PE Recommendations Key Features:

Key Features:  
Title and year of the documentSpanish Recommendations on Economic Evaluation of Health Technologies (2010) (Spanish Version 2009) 
Affiliation of authorsCanary Islands Health Services, Castilla La Mancha University, La Rioja University, Public Health Agency of Barcelona, Vic University, Alto Deba Hospital & Pompeu Fabra University 
Purpose of the documentProvide methodological and reporting guidelines for PE evaluations and evaluation of health technologies 
Standard reporting format includedNo 
DisclosureYes 
Target audience of funding/ author's interestsAll, form regulators to patients and citicents 
PerspectiveA societal perspective is recommended. It is also recomended to include the perspective of the third-party National Health System (NHS) in the analysis. The societal and NHS perspectives should be presented separately. 
IndicationNo references are made 
Target populationRelevant groups or sub-groups need to be defined. 
Subgroup analysisYes 
Choice of comparatorCompare the technology under study with the standard technology used in current health care practices. The choice of alternative technologies for comparison should be justified. 
Time horizonThe time horizon should capture all relevant differences in costs and in the effects of health treatments and resources. In some cases, the time horizon will have to be extended to the individual’s entire life. 
Assumptions requiredYes 
Preferred analytical techniqueAny of the four analysis methods (cost minimization, cost effectiveness, cost utility, and cost benefit) may be used for economic evaluations of health technologies. 
Costs to be includedHere are the recommendations for the allocation of resources and costs: (a) A full description of the chosen perspective should be provided, as this may affect the decision to include or exclude certain costs;… 
Source of costsIt is recommended to rely on official publications, accounts of health care centers, and the fees applied to NHS service provision contracts 
ModelingModelling techniques should be developed in different situations to: (a) extrapolate progression of the clinical outcome (i.e., survival) beyond that observed in a trial (e.g., model the progression of AIDS in asymptomatic patients);… 
Systematic review of evidencesYes 
Preference for effectiveness over efficacyOutcomes may be obtained under conditions that are ideal (efficacy) or reflect real practice (effectiveness). Both types of sources should be used whenever possible, as the information they provide is often complementary 
Preferred outcome measureIn a cost-effectiveness analysis, outcomes are related to the primary endpoint of the underlying clinical trial. The outcomes should be expressed in clinically relevant terms, and where intermediate outcomes are used, the connection to final outcomes must be clear and scientifically proven. In a cost-utility analysis, health benefits or outcomes are measured in QALY gained. 
Preferred method to derive utilityPreferences scores can be measured direct or indirectly. Direct measurements are obtained by surveying people who suffer from the health problem under study to ascertain their preferences or utilities for different states or changes in health. Indirect measures are obtained through previously validated HRQOL patient surveys. Although patients are scored or grouped according to their answers, the numerical values given to individual answers are not obtained directly from the patients but depend rather on the social values previously estimated for the questionnaire. Indirect methods to measure utilities are preferable, as they are easier to obtain, compare, and interpret. However, these considerations do not rule out direct measurements when their use and scientific validity is justified for the study in question. 
Equity issues statedThe criterion underlying equity in economic evaluation is equality of the valuation of outcomes; apart from this, it is not obligatory to include any other criterion a priori in the economic evaluation. 
Discounting costsAn annual discount rate of 3% should be used for the reference case, and 0% and 5% can be applied to the sensitivity analysis for comparison with other studies. 
Discounting outcomesAn annual discount rate of 3% should be used for the reference case, and 0% and 5% can be applied to the sensitivity analysis for comparison with other studies. 
Sensitivity analysis-parameters and rangeA sensitivity analysis to account for uncertainty should be performed justifing modifications made to the sensitivity analysis with respect to the reference case 
Sensitivity analysis-methodsOne-way sensitivity analyses should be applied. If they turn out to be insufficient, multiway analyses should be applied 
Presenting resultsResults should be presented as an incremental analysis (incremental cost per incremental health outcome unit obtained), comparing relevant alternatives, and separating the perspectives (if analyzed from the perspective of society and that of a third-party payer) and subgroups. (a) Present the main outcomes (cost and health outcomes) both separately and together; (b) When a probabilistic analysis is carried out, include a cost-effectiveness/cost-utility plane and the acceptability curve in the findings; (c) Present data and assumptions considered in the analysis as transparently as possible so that any analyst can reproduce the study. 
Incremental analysisYes 
Total costs vs effectiveness (cost/effectiveness ratio)Yes 
Portability of results (Generalizability)Transparency in methods, data, and results is essential to assess the validity of the analysis. It can also help health-care agents generalize or transfer the elements of an economic evaluation to new contexts 
Financial impact analysisN/A 
Mandatory or recommended or voluntaryVoluntary 

Acknowledgement: Carme Pinyol, MD, PhD, MSc, Founder and Director, INNOVA - Strategic Consulting and the ISPOR Spain Chapter (http://www.ispor.org/RegionalChapters/Chapter/Spain)

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