Pharmacoeconomic Guidelines: Spain - Catalonia
Country/Region: Spain - Catalonia
Submission Guidelines
"GUIDE AND RECOMMENDATIONS FOR THE CONDUCT AND PRESENTATION OF ECONOMIC EVALUATIONS AND BUDGET IMPACT ANALYSIS OF MEDICINES WITHIN THE SCOPE OF CATSALUT"
Submission Guidelines Source:
Additional Information:
GAEIP version 1.0
Information current as of Friday, March 1, 2024
Key Features
| Key Features | |
|---|---|
| Type of Guidelines | Submission Guidelines |
| Title and year of the document | "Guide and recommendations for the conduct and presentation of economic evaluations and budget impact analysis of medicines within the scope of CATSALUT" - 2014 (Guía y recomendaciones para la realización y presentación de evaluaciones económicas y análisis de impacto presupuestario de medicamentos en el ámbito del CatSalut.) |
| Affiliation of authors | Jaume Puig Junoy Centre d’Investigació en Economia i Salut (CRES). Universitat Pompeu Fabra, Barcelona. Juan Oliva Moreno Departamento de Análisis Económico. Facultad de Ciencias Jurídicas y Sociales. Universidad de Castilla la Mancha, Toledo. Marta Trapero Bertran Centre d’Investigació en Economia i Salut (CRES). Universitat Pompeu Fabra, Barcelona. Facultad de Terapia Ocupacional, Logopedia y Enfermería. Universidad de Castilla la Mancha, Talavera de la Reina. José María Abellán Perpiñán Facultad de Economía y Empresa. Universidad de Murcia. Max Brosa Riestra Oblikue Consulting, Barcelona. |
| Purpose of the document | The document aims to provide a set of recommendations on how to conduct economic evaluations (EE) and budget impact analysis (BIA) for submission to the Catalan Health Service (CatSalut). The document also provides a reference case and a checklist for authors of EEs and BIAs. |
| Standard reporting format included | Yes. |
| Disclosure | No. |
| Target audience of funding/ author's interests | Pharmaceutical Industry |
| Perspective | Payer's perspective (CatSalut) should be adopted. In a complementary analysis, a social perspective can be adopted. |
| Indication | Indication for which the drug under evaluation is approved. |
| Target population | Target population must be clearly defined, including information on clinical and demographic characteristics, risk factors and comorbidities, healthcare setting and geographic location, usual adherence rates to treatment usual treatment patterns, as well as risk levels within the same clinical condition. |
| Subgroup analysis | Yes, if there is evidence supporting differential treatment effects among subgroups. |
| Choice of comparator | Comparator should be (at least) the most used and most effective/safe clinical alternative. The guidance also mentions that ideally, analysis should include every comparator available in the market. It is also suggested that a separate analysis using the least costly alternative can be useful for decision-making. In any case, choice of comparator should be clearly justified. |
| Time horizon | Long enough to capture differences in costs and effects between treatments. If the analysis is based on a clinical trial with short term follow-up data, modelling is recommended to extrapolate results. The guideline also recommends to undertake a complementary analysis with a shorter time horizon (3-5 years). |
| Assumptions required | Yes. They should be clearly stated and justified. |
| Preferred analytical technique | The preferred analytical technique is the cost-utility analysis (CUA). Cost-effectiveness analysis (CEA) are allowed (using life years gained as outcome measure whenever possible) if it is impossible to carry out a CUA. Cost-minimization analysis (CMA) is allowed if there is enough evidence to support that the interventions under comparison have identical clinical effects. Other types of evaluations can be presented as part of complementary analysis. |
| Costs to be included | Healthcare costs. Non-health costs such as job losses, social services and non-professional-informal caregivers, when included, should be presented separately. |
| Source of costs | Unit costs should preferably come from public prices, publications, tariffs applied to contracts for provision of services to CatSalut or accounting costs from centers. If the analysis also includes services that are not provided by CatSalut, market prices should be used. Sources should be clearly justified and the year for which the costs were calculated stated. |
| Modeling | The use of modelling techniques is recommended to: extrapolate results beyond clinical trial observations; derive final results from intermediate measures; model data from multiple sources to compile essential parameters for a decision analysis; and model observed results from trials or systematic reviews to reflect potential circumstances in a different clinical setting or studied population. If modelling is used, the choice of model, structural assumptions and key parameters used, should be clearly justified. |
| Systematic review of evidences | Yes. To obtain the best available clinical evidence, a systematic review should be carried forward. |
| Preference for effectiveness over efficacy | Both are accepted and if possible both should be used since they provide complementary information. |
| Preferred outcome measure | If CUA, Quality Adjusted Life Years (QALY). Instruments to valuation of recommended preferences are the EQ-5D and SF-6D. If CEA, life years gained (LYG). |
| Preferred method to derive utility | EQ-5D and SF-6D. If neither EQ-5D nor SF-6D are used, and a different instrument is chosen, this must be appropriately justified. In this case the validity, reliability and practicality of the method used must be informed and the procedure used to obtain utility values must be clearly described. |
| Equity issues stated | The guideline states that "the underlying equity criterion will be the equal valuation health outcomes (a QALY is a QALY)". If considered relevant, any other arguments of social justice should be presented in a narrative form or in a separate analysis. |
| Discounting costs | 3% annual discount rate in the base case. 0% and 5% annual discount rates recommended in sensitivity analysis. |
| Discounting outcomes | 3% annual discount rate in the base case. 0% and 5% annual discount rates recommended in sensitivity analysis. |
| Sensitivity analysis-parameters and range | Uncertainty should be analyzed by a sensitivity analysis covering the parameters, structure and methodological choices or the model. |
| Sensitivity analysis-methods | At least one deterministic sensitivity analysis, univariate type and extreme values (best and worst scenarios) must be carried out, justifying the choice of variables and parameters for sensitivity analysis and the interval at which vary. Whenever possible, performing a probabilistic sensitivity analysis with the plane of cost-utility (or cost-effectiveness) and acceptability curve is recommended. |
| Presenting results | Findings should be presented using an incremental analysis of both health costs and benefits separately, along with the incremental cost-effectiveness ratio. Standard deviation and a 95% confidence intervals should be included for costs and outcomes. |
| Incremental analysis | Yes. |
| Total costs vs effectiveness (cost/effectiveness ratio) | Yes. |
| Portability of results (Generalizability) | Data sources for costs and outcomes should closely align with their intended application. Transparency in detailing data and model assumptions is a key characteristic for evaluating the analysis's validity and assessing the potential for generalizing or applying its results and conclusions to diverse contexts beyond the original one. |
| Financial impact analysis | This Guideline also includes the recommendations for BIA to be submitted to the Catsalut. |
| Mandatory or recommended or voluntary | Recommended |
Acknowledgement: