Time to access to novel anticancer drugs and the correlation with ESMO-Magnitude of Clinical Benefit Scale in Slovenia.

Objectives: Timely access to novel anticancer drugs is challenging and value frameworks such as the European Society of Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) could assist in drug prioritization. We assessed the overall time to access to novel anticancer drugs in Slovenia and its correlation with ESMO-MCBS scores.Methods: Anticancer drugs with European Medicines Agency marketing authorization (EMA MA), applying for national reimbursement approval (NRA) in the period 2008-2018 with assigned ESMO-MCBS score, were included. Publically available data from EMA and the Slovenian National Health Insurance Institute were used for time calculations.Results: Among 53 studied drugs; a majority (47) of them obtained reimbursement approval within the observed time. The median time to EMA MA was 397 (range 98-615) days with the NRA requiring additional 422 (range 154-892) days. Neither time to EMA MA nor NRA correlated with ESMO-MCBS substantial clinical benefit (p = 0.332 and p = 0.965, respectively).Conclusions: In Slovenia, time to access to novel anticancer drugs exceeds two years and, more importantly, is equally long for drugs with or without substantial clinical benefit. Integration of the ESMO-MCBS into reimbursement deliberations could improve access to drugs with substantial clinical benefit.