OBJECTIVES

Examine the institutional, legal, and political factors that have impeded the use of economic evaluation for pricing and reimbursement (P&R) of new medicines in Spain.

METHODS

Literature review and narrative description of the current institutional, legal and political framework.

RESULTS

The application of the efficiency criterion has been clearly required by Spanish laws at the national level for several years now. However, the real use of cost-effectiveness analysis in the process of P&R of new medicines is still unknown. The national Spanish Agency for Pharmaceuticals and Health Products (AEMPS) carries out clinical appraisal of new medicines but not does not estimate costs or evaluate cost-effectiveness. Spain also has an established network of national and regional Health Technology Assessment (HTA) agencies which undertake clinical and economic evaluation of other health technologies but, so far, these institutions have not been used in P&R of new medicines. There are currently several ongoing initiatives in economic evaluation by various agents but they remain uncoordinated.

CONCLUSIONS

Poor governance at the highest-level of decision making is the main reason for the lack of interest in economic evaluation. There is some moral hazard from the central government which is not directly responsible for the budget impact on regional payers of P&R decisions. To increase transparency and governance, it is recommended to:

• Strengthen the competences and resources of the recently created Advisory Committee for the financing of pharmaceutical benefit of the NHS
• Establish an integrated network of AEMPS with the national and regional HTA agencies to appraise and evaluate all types of health technologies, independent of political influence
• Increase the participation of regional payers and patient groups in national P&R decision-making and consultation
• Provide clarity about the efficiency criteria and methodology in P&R
• Publish evidence and reasons for P&R decisions