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The white paper available only in Spanish language

By Bordoy Coma-Cros Clara, Cruz Arrioja Jessica, Manau Vilalta Marc, Castillo Gutiérrez Chus, Vázquez Roso Manuel

Pricing & reimbursement (P&R) decisions for new drugs in Spain are based on the criteria set in the Law on Guarantees and Rational Use of Medicinal Products (LGURM) (RD 1/2015), and the clinical evidence, economic value, and positioning of each new drug in relation to the Therapeutic Positioning Report (TPR). Despite this clear framework, the weight of each criterion on P&R decisions is not transparent.

For oncology therapies in particular, timeline of the P&R decision is critical, however, the gap between the approval of new medicines by EMA and their reimbursement in Spain can be noticeable. As of January 2022, more than 100 TPRs had a delay of 400 days. Both clinicians and patients regret these delays in access and want to streamline evaluation processes with new TPRs.

This white paper explores how companies’ target prices are impacted by the different variables leveraged during the P&R process for oncology and oncohematology’s first indication.

White Paper Summary: Methodology, results, and recommendations

Based on LGURM and TPRs, hypotheses around the relationship between different variables and expected price were developed. Then, using the Wilcoxon or Kruskal-Wallis tests, those hypotheses were statistically analyzed.

Although the process is complex and heterogeneous, the additional clinical benefit is a statistically significant criterion in the decision-making process. While there is no statistically significant relationship between other factors when predicting P&R results, there are interesting trends.

A more structured, transparent, and predictable methodology that considers LGURM priorities would help set expectations and communication among stakeholders. Despite the limited sample, the results can serve as a starting point to increase transparency and improve process structure to encourage a more fluid dialogue in evaluating and financing drugs in Spain.

Have questions or comments about the white paper “Relative Weight of the Variables Evaluated Through the Therapeutic Positioning Reports in the Pricing and Reimbursement of Oncological and Oncohematology Medicines in Spain”? Contact us.