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Observational Study
. 2024 Jan;271(1):340-354.
doi: 10.1007/s00415-023-11955-0. Epub 2023 Sep 16.

Intravenous or subcutaneous natalizumab in patients with relapsing-remitting multiple sclerosis: investigation on efficiency and savings-the EASIER study

Collaborators, Affiliations
Observational Study

Intravenous or subcutaneous natalizumab in patients with relapsing-remitting multiple sclerosis: investigation on efficiency and savings-the EASIER study

Massimo Filippi et al. J Neurol. 2024 Jan.

Abstract

Introduction: EASIER is a multicenter, observational, cross-sectional study investigating the consumption of healthcare resources, including healthcare professional (HCP) active working time, the costs associated with the current natalizumab intravenous (IV) administration, and the potential impact of the adoption of subcutaneous (SC) route.

Methods: The EASIER study has three parts: (1) time and motion study to measure healthcare resources and working time needed for natalizumab IV administration using a digital data collection tool operated directly by HCPs; (2) HCP structured questionnaire-based estimation of the potential impact of natalizumab SC vs. IV administration; and (3) patient survey on the burden of natalizumab administration.

Results: Nine Italian multiple sclerosis (MS) centers measured 404 IV natalizumab administration procedures and administered 26 HCP questionnaires and 297 patient questionnaires. Patients had a mean of 52 (range 1-176) previous IV administrations and spent a mean (median, IQR) of 152 (130, 94-184) minutes in the center per each IV procedure, with IV infusion covering 50% of the total. Including patient travel time, an average of 5 h was dedicated to each IV administration. Active working time by HCP amounted to 29 min per IV administration procedure, 70% of which by nursing staff. With adoption of the SC route, HCPs estimated a 50% reduction in patient procedure time and 55% lower HCP active working time. This translated into a 63% cost reduction for the MS center per natalizumab administration procedure.

Conclusions: SC natalizumab administration will consistently reduce consumption of patient and HCP times per procedure and associated costs.

Keywords: Costs; Intravenous administration; Multiple sclerosis; Natalizumab; Subcutaneous administration; Time.

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Conflict of interest statement

MF: is Editor-in-Chief of the Journal of Neurology, Associate Editor of Human Brain Mapping, Associate Editor of Radiology, and Associate Editor of Neurological Sciences; received compensation for consulting services from Alexion, Almirall, Biogen, Merck, Novartis, Roche, Sanofi; speaking activities from Bayer, Biogen, Celgene, Chiesi Italia SpA, Eli Lilly, Genzyme, Janssen, Merck-Serono, Neopharmed Gentili, Novartis, Novo Nordisk, Roche, Sanofi, Takeda, and Teva; participation in Advisory Boards for Alexion, Biogen, Bristol-Myers Squibb, Merck, Novartis, Roche, Sanofi, Sanofi-Aventis, Sanofi-Genzyme, Takeda; scientific direction of educational events for Biogen, Merck, Roche, Celgene, Bristol-Myers Squibb, Lilly, Novartis, Sanofi-Genzyme; he receives research support from Biogen Idec, Merck-Serono, Novartis, Roche, Italian Ministry of Health, Fondazione Italiana Sclerosi Multipla, and Fondazione Italiana di Ricerca per la SLA; LG: has received funding for travel to attend scientific events or speaker honoraria from Merck, Biogen Idec, Sanofi-Aventis, Teva Pharmaceutical Industries Ltd., Roche, Novartis and Bayer Schering Pharma; and receives institutional research support from Biogen Idec and Serono Foundation; AC: has served on advisory boards and/or received honoraria for speaking or consultation fees from Biogen, Merck-Serono, Novartis, Roche, Sanofi-Genzyme; RT: has served on advisory boards and/or received honoraria for speaking or consultation fees from Biogen, Merck-Serono, Novartis, Roche, Sanofi-Genzyme, and Teva; MRV: Biogen, Sanofi, Teva, Merck, Roche; SM: consultation and speaking fees from Sanofi-Genzyme, Biogen-Idec, Merck Serono, Novartis, Celgene-Bristol-Myers Squibb Company, Teva; FG: received research funding from Roche, fees for advisory boards and speaking honoraria from Biogen, Novartis, Sanofi-Genzyme, Merck Serono and Roche; CC: Personal compensation for advisory board and speaking for Merck Serono, Novartis, Almirall, Biogen, Celgene BMS, and Roche; VBM: has received research grants from the Italian MS Society, and Roche, and honoraria from Bayer, Biogen, Merck, Mylan, Novartis, Roche, Sanofi-Genzyme, and Teva; CZ: nothing to disclose; DP, LS: are employees of and may hold stock/stock options in Biogen.

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