Pharmacoeconomic Guidelines: Spain-Hospitals
Country/Region: Spain-Hospitals
Published PE Recommendations
| Guide for Economic Evaluation and Budgetary Impact in Medication Assessment Reports (Guía de evaluación económica e impacto presupuestario en los informes de evaluación de medicamentos) |
Published PE Recommendations Source:
Information current as of Monday, April 1, 2024
Key Features
| Key Features | |
|---|---|
| Type of Guidelines | Published PE Recommendations |
| Title and year of the document | Guide for Economic Evaluation and Budgetary Impact in Medication Assessment Reports - 2016 |
| Affiliation of authors | GENESIS (Grupo de Evaluación de Novedades, Estandarización e Investigación en Selección de Medicamentos) - SEFH (Sociedad Española de Farmacia Hospitalaria) |
| Purpose of the document | The document aims to aid the applicant in the completion of the economic section of the drug evaluation reports submitted to the pharmacy and therapeutics committees. |
| Standard reporting format included | Yes. |
| Disclosure | No. |
| Target audience of funding/ author's interests | Pharmacy and therapeutics committees of hospitals and drug evaluation committees of the autonomous communities. |
| Perspective | Payer's perspective (health system). Costs of primary care and hospital costs should be presented in a separate manner. If societal costs are considered to be substantial, they should be included in a sensitivity analysis. |
| Indication | No reference made. |
| Target population | If relevant sub-groups are identified, sub-group analysis should be carried forward. |
| Subgroup analysis | Relevant sub-groups of patients need to be defined. |
| Choice of comparator | Relevant comparators from published evidence (comparators used in clinical trials) and technologies used in current clinical practice should be included as comparators. In any case, choices must be clearly justified. |
| Time horizon | Long enough to capture all relevant effects for each of the alternatives being compared. Time horizon should be the same for costs and effects. |
| Assumptions required | No clear reference made (only briefly mentioned in sensitivity analysis, suggesting that parameters or assumptions over which there is uncertainty should be varied). |
| Preferred analytical technique | Cost minimization (CMA), cost-effectiveness (C-E) and cost-utility (C-U) analysis mentioned. CMA is suggested when there is therapeutic equivalence between the compared alternatives. C-E/C-U is suggested when one of the comparators demonstrates added therapeutic value. |
| Costs to be included | Direct medical costs included. If non-medical costs are considered relevant, then a separate analysis from societal perspective should be presented including the relevant non-medical costs. |
| Source of costs | Drug prices: http://www.msc.es/profesionales/nomenclator.do, pharmaceutical companies pricing lists and the database from the ""Consejo General de Colegios Oficiales de Farmacéuticos" (General Council of Official Colleges of Pharmacists). Other relevant medical costs: The eHealth database from Oblikue, from the Ministry of Health, Social Services, and Equality or from data published by the autonomous communities. |
| Modeling | No specifics given. |
| Systematic review of evidences | No reference made. |
| Preference for effectiveness over efficacy | Efficacy mentioned throughout the text, albeit no clear preference stated. |
| Preferred outcome measure | QALYs preferred. If unavailable, life years suggested. If life years are also not available, the most relevant outcome measure available should be used. |
| Preferred method to derive utility | EQ-5D from patients with the condition preferred. SF-6D and SF-36 and direct elicitation methods such as standard gamble or time trade-off also mentioned. |
| Equity issues stated | Equity issues only briefly mentioned in relation to orphan drugs. Assessment and financing of orphan drugs at a national level recommended to avoid equity issues. |
| Discounting costs | 3% in the base-case. 0% to 5% in sensitivity analysis. If there is a need to simplify the analysis, no discount rate can be applied in the base case, including discount rates as part of sensitivity analysis. |
| Discounting outcomes | 3% in the base-case. 0% to 5% in sensitivity analysis. If there is a need to simplify the analysis, no discount rate can be applied in the base case, including discount rates as part of sensitivity analysis. |
| Sensitivity analysis-parameters and range | Variables, models or assumptions over which there is uncertainty should be varied in the sensitivity analysis. |
| Sensitivity analysis-methods | Probabilistic sensitivity analysis is preferred. If it is impossible to perform probabilistic analysis, the recommendation is to perform at least univariate analysis. |
| Presenting results | A table should be included with baseline results of the analysis, showing costs and outcomes for each alternative, differences in costs and outcomes between the alternatives and the ICER. |
| Incremental analysis | Yes. |
| Total costs vs effectiveness (cost/effectiveness ratio) | Yes. |
| Portability of results (Generalizability) | If including variables/results from literature in the model, these should come from quality sources and be generalizable to the spanish context. If a published economic model is used for analysis, study results should be presented in a disaggregated manner, clearly indicating whether any of these have been tested in a sensitivity analysis. Clear justification must be provided regarding which parameters or results can be generalized and why. |
| Financial impact analysis | Yes. Recommendations for BIA given. |
| Mandatory or recommended or voluntary | Recommended. |
Acknowledgement: