Pharmacoeconomic Guidelines: Spain
Country/Region: Spain
Published PE Recommendations
Guidelines for Economic Evaluation of Pharmaceuticals, Ministry of Health, Spain, 2024
Published PE Recommendations Source:
Additional Information:
Information current as of Tuesday, March 19, 2024
Key Features
| Key Features | |
|---|---|
| Type of Guidelines | Published PE Recommendations |
| Title and year of the document | Guidelines for Economic Evaluation of Pharmaceuticals, Ministry of Health, Spain, 2024 |
| Affiliation of authors | Comité Asesor para la Financiación de la Prestación Farmacéutica del Sistema Nacional de Salud (Advisory Committee for the Financing of Pharmaceutical Provision of the National Health System). |
| Purpose of the document | To provide a standardized framework for conducting economic evaluations of pharmaceuticals seeking public funding or pricing determination. |
| Standard reporting format included | Yes. |
| Disclosure | Funding sources and conflicts of interest are required to be disclosed for all participants in the economic evaluation process. |
| Target audience of funding/ author's interests | Primarily intended for policymakers, healthcare professionals, and researchers involved in the evaluation and decision-making processes related to pharmaceutical funding and pricing. |
| Perspective | Public healthcare perspective (National Health System). |
| Indication | Evaluation of pharmaceuticals for specific medical indications. |
| Target population | Individuals eligible to receive the medication for the evaluated indication, ensuring clarity and identification without confusion. |
| Subgroup analysis | Yes, exploration of relevant heterogeneity among different subpopulations and justification for subgroup analyses. |
| Choice of comparator | The comparator of first choice should be the standard of care, although other comparators may be considered when different alternatives exist in different subpopulations. In complementary analysis, comparisons will also be made with the most efficacious/effective, most efficient and lowest-priced alternative. The inclusion/exclusion of comparators must be justified. |
| Time horizon | Time horizon capturing all differential effects of interventions on health and resource use compared to alternatives. |
| Assumptions required | Assumptions regarding efficacy, resource use, and costs are required, with explicit justification for their inclusion in the analysis. |
| Preferred analytical technique | Modeling techniques are recommended, ensuring transparency and avoidance of overestimation or underestimation of long-term results. |
| Costs to be included | All relevant resources for the analysis--identified, measured, and valued consistently with the chosen perspective(s) and time horizon. |
| Source of costs | Detailed information on resources used, measured (in physical units), and valued (with unit costs or prices) presented transparently. |
| Modeling | It will be essential to justify the suitability of the model and describe the assumptions adopted in it. In addition, it is necessary to deliver the files where the model has been developed, taking into account that it can be replicable. |
| Systematic review of evidences | Yes, reliance on randomized clinical trials and systematic reviews with meta-analyses for comparative clinical benefit evaluation. |
| Preference for effectiveness over efficacy | Yes, preference for clinically relevant outcome measures such as overall survival or Life Years Gained (LYG), alongside safety measures. |
| Preferred outcome measure | Quality-Adjusted Life Years (QALYs) for cost-utility analysis, alongside clinically relevant measures for cost-effectiveness analysis. |
| Preferred method to derive utility | EQ-5D and SF-6D instruments recommended for measuring and valuing preferences. |
| Equity issues stated | Yes, critical analysis of applicability to the Spanish context and within-country transferability of results, including considerations of ethical and equity concerns. |
| Discounting costs | Costs occurring beyond the first year will be updated to the base year or reference year by applying an annual discount rate. In the base case, an annual discount rate of 3% will be applied to both costs and health outcomes. This parameter will be varied in sensitivity analyses, using values of 5% for costs. |
| Discounting outcomes | Outcomes occurring beyond the first year will also be discounted to the base year or reference year at a rate of 3% annually. This parameter will be varied in sensitivity analyses, using values of 0% and 5% for outcomes. |
| Sensitivity analysis-parameters and range | The main sources of uncertainty will be explicitly identified, and a sensitivity analysis will be conducted to assess the robustness of the results obtained in the base case. Both univariate and multivariate deterministic sensitivity analyses of the parameters with uncertainty will be performed, and the results will be presented using a tornado diagram. Additionally, a probabilistic sensitivity analysis will be conducted, detailing the methodology used and presenting the results using confidence ellipses, scatter plots, and a cost-effectiveness/utility acceptability curve. The range of values within which the true estimation of the incremental cost-effectiveness/utility ratio of the proposed medication is likely to fall will be described and justified. |
| Sensitivity analysis-methods | Sensitivity analysis will be conducted to systematically explore the uncertainty associated with the chosen parameters for the economic evaluation. This will include univariate and multivariate deterministic sensitivity analyses to identify parameters (or combinations of parameters) that have the greatest influence on the evaluation results. Probabilistic sensitivity analysis, based on Monte Carlo simulations or similar analytical alternatives, will also be performed. Sensitivity analyses will be used to derive a list of priorities for future evidence needs and guide the pricing and funding model, including flexible models. Future evidence needs will aim to substantiate formal requests for additional evidence collection for a subsequent reassessment stage. The values chosen for distribution parameters must be justified and based on existing guidelines. |
| Presenting results | Costs and health outcomes should be presented separately, indicating standard deviation or 95% confidence interval. Presentation of data and assumptions used should be transparent. Results should be presented through incremental analysis of costs and health outcomes, and incremental cost-effectiveness/utility ratio, and uncertainties and sensitivity analyses results should be clearly presented. The main components of cost and health benefit should be disaggregated before combining. Discounted and undiscounted values should both be presented, as should sensitivity analyses highlighting sensitive parameters with probabilistic sensitivity analysis presented for the reference case and scenarios. Present scenario analysis on the price of new technology for target population and subgroups. Short and long-term effects results should be presented separately if they are from clinical trials and modeled outcomes. Model structure, data, probabilities, assumptions, and validation should be detailed if, applicable. A discussion should assess the robustness of results and identify conditions altering conclusions. |
| Incremental analysis | Yes, incremental analysis presented for cost-utility and cost-effectiveness comparisons. |
| Total costs vs effectiveness (cost/effectiveness ratio) | Total costs and effectiveness compared to derive cost-effectiveness ratios. |
| Portability of results (Generalizability) | Examination of the generalizability of results within the Spanish context and transferability of results to other settings, considering factors such as local data availability and applicability. |
| Financial impact analysis | The financial impact of evaluated pharmaceuticals on the healthcare system considered, though specific methods may vary. |
| Mandatory or recommended or voluntary | Guidelines are recommended for conducting economic evaluations of pharmaceuticals seeking public funding or pricing determination. |
Acknowledgement: