%0 Systematic Review
%T Use of follow-on disease-modifying treatments for multiple sclerosis: Consensus recommendations.
%A Brownlee WJ
%A Wolf C
%A Hartung HP
%A Dingermann T
%A Anshasi N
%A Clark RA
%A Trojano M
%A Selmaj K
%A Uitdehaag BM
%A Tur C
%A Wuerfel J
%A Dallmann G
%A Witte J
%A Sintzel M
%A Bobrovnikova O
%A Cohen JA
%J Mult Scler
%V 28
%N 14
%D 12 2022
%M 36000489
%F 5.855
%R 10.1177/13524585221116269
%X As patents for multiple sclerosis (MS) therapies expire, follow-on disease-modifying treatments (FO-DMTs) become available at reduced cost. Concerns exist that cheaper FO-DMTs are used simply to reduce healthcare costs. However, the well-being of people with MS should take priority.<BR>To identify best practices for FO-DMT development and use by agreeing on principles and consensus statements through appraisal of published evidence.<BR>Following a systematic review, we formulated five overarching principles and 13 consensus statements. Principles and statements were voted on by a multidisciplinary panel from 17 European countries, Argentina, Canada and the United States.<BR>All principles and statements were endorsed by >80% of panellists. In brief, FO-DMTs approved within highly regulated areas can be considered effective and safe as their reference products; FO-DMTs can be evaluated case by case and do not always require Phase III trials; long-term pharmacovigilance and transparency are needed; there is lack of evidence for multiple- and cross-switching among FO-DMTs; and education is needed to address remaining concerns.<BR>Published data support the use of FO-DMTs in MS. The consensus may aid shared decision-making. While our consensus focused on Europe, the results may contribute to enhanced quality standards for FO-DMTs use elsewhere.