Pharmacoeconomic Guidelines: Spain
Country/Region: Spain
Published PE Recommendations
Spanish Recommendations on Economic Evaluation of Health Technologies (2010) (Spanish Version 2009)
PDF in English; PDF in Spanish
PDF in English; PDF in Spanish
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."
Information current as of Friday, July 29, 2022
Key Features
| Key Features | |
|---|---|
| Type of Guidelines | Published PE Recommendations |
| Title and year of the document | Spanish Recommendations on Economic Evaluation of Health Technologies (2010) (Spanish Version 2009) |
| Affiliation of authors | Canary 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 document | Provide methodological and reporting guidelines for PE evaluations and evaluation of health technologies |
| Standard reporting format included | No |
| Disclosure | Yes |
| Target audience of funding/ author's interests | All, form regulators to patients and citicents |
| Perspective | A 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. |
| Indication | No references are made |
| Target population | Relevant groups or sub-groups need to be defined. |
| Subgroup analysis | Yes |
| Choice of comparator | Compare 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 horizon | The 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 required | Yes |
| Preferred analytical technique | Any 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 included | Here 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 costs | It is recommended to rely on official publications, accounts of health care centers, and the fees applied to NHS service provision contracts |
| Modeling | Modelling 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 evidences | Yes |
| Preference for effectiveness over efficacy | Outcomes 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 measure | In 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 utility | Preferences 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 stated | The 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 costs | An 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 outcomes | An 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 range | A sensitivity analysis to account for uncertainty should be performed justifing modifications made to the sensitivity analysis with respect to the reference case |
| Sensitivity analysis-methods | One-way sensitivity analyses should be applied. If they turn out to be insufficient, multiway analyses should be applied |
| Presenting results | Results 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 analysis | Yes |
| 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 analysis | N/A |
| Mandatory or recommended or voluntary | Voluntary |
Acknowledgement: