Reimbursement Recommendations and Pricing Status of Non-Small Cell Lung Cancer Drugs Authorized in Spain

OBJECTIVES: Non-small cell lung cancer (NSCLC) is a leading cause of cancer-related mortality globally and in Spain. Recent advances have resulted in new therapies authorized by the European Medicines Agency (EMA) and the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Patient access in Spain is governed by pricing and reimbursement decisions made by the Comisión Interministerial de Precios de los Medicamentos (CIPM). These decisions are based on evaluations of information provided by drug manufacturers and internal reimbursement recommendations formalized in Informes de Posicionamiento Terapéutico (IPTs).

METHODS: A list of NSCLC drugs authorized by the EMA since January 2019 was compiled. IPTs were reviewed to extract and categorize information regarding reimbursement recommendations and criteria for decision-making. Then, CIPM pricing decisions for these drugs were collected to understand if the level of recommendation was aligned with the reimbursement status.

RESULTS: Since 2019, the EMA has authorized 39 NSCLC products, including 14 biosimilars/generics. Of the 25 new reference products, 15 received government funding, with 12 evaluated in IPTs and 3 not assessed. Ten drugs were not funded, with 4 assessed in IPTs and 6 not evaluated. Generally, IPT recommendation levels aligned with pricing decisions. Economic evaluations were featured in only one IPT.

CONCLUSIONS: These results highlight the distribution of reimbursement recommendations and the influence of positioning evaluations on funding decisions for NSCLC drugs in Spain. While there was generally an alignment between the existing reimbursement recommendations and pricing decisions, the unjustified absence of evaluations in some cases shows the limited visibility of IPTs in the drug approval process in Spain. Additionally, the absence of economic evaluations shows their limited impact on pricing decisions thus far.