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)

PDF in Spanish

Published PE Recommendations Source:
GENESIS (Grupo de Evaluación de Novedades, Estandarización e Investigación en Selección de Medicamentos) - SEFH (Sociedad Española de Farmacia Hospitalaria)

Information current as of Monday, April 1, 2024

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:

E. Abril Seyahian, PhD, MSc, HEHTA, University of Glasgow contributed to this key feature form.
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