Evaluation of new medicines in Spain and comparison with other European countries

Abstract

Objective: To compare the use of health technology assessment (HTA) as a tool to support pricing and reimbursement (P&R) of new medicines in Spain with England, Sweden, France and Germany.

Method: For each country, the literature is used to identify the purpose and timing of the P&R decision, the HTA and decision-making procedures used to generate evidence, and the criteria used to make decisions.

Results: Results are presented as a summary of the HTA landscape for P&R of new medicines in each country. Comparisons are made between Spain and other countries regarding the procedure and implementation of HTA.

Conclusions: Based on these assessments, we made recommendations for how HTA might develop in Spain with the aim of improving governance and efficiency. Spain has made considerable progress in recent years, but still falls short of international standards in terms of independence of the HTA agencies and decision-making committees from political influence and industrial policy, the setting of prices of medicines in relation to health gain, improve the transparency of the process and results of the evaluation, and promote the participation of stakeholders. In common with other countries, Spain needs to clarify the role of cost-effectiveness criteria. Further progress needs to be made to coordinate effort across the various agencies, strengthen technical staff, and ensure equitable access to medicines between regions.

Keywords: España; Evaluación de la tecnología sanitaria; Evaluación de tecnología sanitaria; Financiación; Health policy; Health technology appraisal; Health technology assessment; Precio y reembolso; Pricing and reimbursement; Spain.