OBJECTIVES: To estimate the clinical impact of the time elapsed between a new drug’s authorization by the EMA, and its reimbursement in Spain.

METHODS: Two molecules were analysed: trastuzumab-deruxtecan in unresectable/metastatic HER2+ and HER2-low breast cancer (BC); and sacituzumab-govitecan in unresectable/metastatic triple-negative BC (mTNBC). The potential years of overall survival lost (YOSL) and years of progression-free survival lost (YPFSL) were estimated, considering the time to drug's reimbursement, the number of patients affected during this time, and the incremental clinical benefit observed in the clinical trials (RCT) that supported their authorization. Time until reimbursement was calculated as days elapsed between published EMA authorization date and its inclusion date in Nomenclátor de Facturación in Spain. For trastuzumab-deruxtecán, which had not been reimbursed for HER2-low when the analysis was conducted, the cut-off date of 12/03/2024 was considered. The estimation of affected patients was obtained from the IQVIA-Oncology Dynamics database. The incremental clinical benefit per patient was calculated as the difference in the median of overall survival and progression-free survival between the assessed drug and its comparator in the RCT. A sensitivity analysis was performed considering only 85% and 70% of potential affected patients and discounting 180 days for administrative tasks.

RESULTS: The time until reimbursement of trastuzumab-deruxtecan in HER2+ BC had an estimated impact of 1,715 potential YOSL in 3L+ (sensitivity analysis range (SA) 1,142-1,458) and 3,446 YPFSL in 2L+ (SA:980-2,929), and an impact to the cut-off date of HER2-low BC of 1,547 potential YOSL (SA:874-1,315) and 1,125 potential YPFSL (SA:636-956). The time until reimbursement of sacituzumab-govitecan in mTNBC had an estimated impact of 883 potential YOSL (SA:458-751) and 559 potential YPFSL (SA:290-475).

CONCLUSIONS: These results provide possible metrics to quantify the benefits that can be obtained if time to availability of medicines for patients is cut short through planned public policies.