Economic Evaluation for Pricing and Reimbursement of New Drugs in Spain: Fable or Desideratum?

Abstract

Background: The economic evaluation of healthcare technologies has become in many countries a basic tool for reimbursement, pricing and purchasing decisions. Objective: The objective of this article is to examine the institutional, legal, and political factors that have impeded the application of economic evaluation and the criterion of efficiency in the process of pricing and reimbursement of new medicines in Spain. Methods: Narrative description of the current institutional framework for the use of economic evaluation in pricing and reimbursement in Spain, legal and policy framework in the field of evaluation of new medicines, and stakeholder initiatives and policies related to the use of economic evaluation outside of the pricing and reimbursement process. Results: Spain has an institutional framework created and established over the last years that could have facilitated a formal use of economic evaluation in the process of pricing and reimbursement. Nevertheless, the real use of economic evaluation at the central or regional level is still unknown, although application of the efficiency criterion, linking to cost-effectiveness, has been clearly required by Spanish laws and regulations at the national level. We highlight a certain degree of moral hazard from the central government that is not directly responsible for the budget impact of reimbursement and pricing decisions. There are currently a number of ongoing initiatives in the field of 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. A profound political change, supported by transparency and accountability, is required before the criterion of efficiency can be fully considered in the process of pricing and reimbursement of new medicines in Spain.

Reimbursement of innovative pharmaceuticals in English and Spanish hospitals—The example of isavuconazole

“…Therefore, the Comisión Interministerial de Precios de Medicamentos y Productos Sanitarios (CIPM)—consisting inter alia of members of four different ministries and three members from different Autonomous Communities (AC)—decides on public reimbursement by considering the IPT and the drug's budget impact 34 . Findings of the value dossier are relevant for the negotiation about the reimbursement pricing process (for patented drugs) which takes place at a national level between the Ministry of Health and the respective pharmaceutical company 34 . Having reached an agreement (less mandatory rebate of, that is 4% for orphan drugs), 36–38 decision‐making power is forwarded to the AC.…”

“…34 Findings of the value dossier are relevant for the negotiation about the reimbursement pricing process (for patented drugs) which takes place at a national level between the Ministry of Health and the respective pharmaceutical company. 34 Having reached an agreement (less mandatory rebate of, that is 4% for orphan drugs), [36][37][38] decision-making power is forwarded to the AC. On regional level, further discounts can be negotiated between the AC and the pharmaceutical company.…”

“…Depending on regional regulations, different committees, such as in hospitals the Comisión de Farmacia y Terapéutica, may then additionally decide whether the drug is included in the hospital portfolio. 34,39 Considering patients who underwent an allogeneic HSCT, four AP-GRD codes (007-1, 007-2, 007-2, and 007-4) were identified.…”

HTA Around the World: Broadening Our Understanding of Cross-Country Differences

“…Oliva et al examine the factors that have influenced the limited use of economic evaluation in pricing and reimbursement of innovative drugs in Spain. 5 Based on the findings from a thorough narrative review of the current institutional, legal, and policy framework in Spain (along with stakeholders' initiatives), they argue that poor governance at the highest level of decision making is the main reason for the restricted use of economic evaluation in reimbursement decisions. Although the regulatory framework encourages the use of these tools, cultural and political barriers have impeded their wider application in healthcare decision making.…”

“…Although the regulatory framework encourages the use of these tools, cultural and political barriers have impeded their wider application in healthcare decision making. 5 The article by Bijlmakers et al sheds light on the role of culture and social values in healthcare decision making by investigating the impact of an innovative policy initiative called the "Citizen Forum" in The Netherlands. 6 The Citizen Forum was established to provide insights into citizens' values and the criteria for decisions pertaining to the health benefits package.…”