About the White Paper
White paper available in Spanish only
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.
Available in Spanish, 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. Download “Peso relativo de las variables evaluadas mediante los informes de posicionamiento terapéutico en la decisión de financiación y precio de medicamentos oncológicos y oncohematológicos en España (Relative Weight of the Variables Evaluated Through the Therapeutic Positioning Reports in the Pricing and Reimbursement of Oncological and Oncohematology Medicines in Spain)”.
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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.
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.
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