Urska Janzic1, Lea Knez2,3, Andrej Janzic4, Tanja Cufer1,5. 1. Department of Medical Oncology, University Clinic Golnik, Golnik, Slovenia. 2. Pharmacy Department, University Clinic Golnik, Golnik, Slovenia. 3. Faculty of Pharmacy, University of Ljubljana, Ljubljana, Slovenia. 4. Division of Pharmacoeconomics, Market Monitoring and HTA, Agency for Medicinal Products and Medical Devices of the Republic of Slovenia, Ljubljana, Slovenia. 5. Medical Faculty, University of Ljubljana, Ljubljana, Slovenia.
Abstract
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.
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.
Entities:
Keywords:
Anticancer drugs; ESMO-MCBS; drug access; reimbursement decision; value frameworks
Authors: Sasha Thomson; Louis Everest; Noah Witzke; Tina Jiao; Seanthel Delos Santos; Vivian Nguyen; Matthew C Cheung; Kelvin K W Chan Journal: Cancer Med Date: 2021-12-01 Impact factor: 4.452