Use of follow-on disease-modifying treatments for multiple sclerosis: Consensus recommendations

Wallace J. Brownlee, Christian Wolf, Hans-Peter Hartung, Theo Dingermann, Nadia Anshasi, Richard A. C. Clark, Maria Trojano, Krzysztof Selmaj, Bernard M. J. Uitdehaag, Carmen Tur, Jens Wuerfel, Gabriele Dallmann, Julian Witte, Martina Sintzel, Olga Bobrovnikova, Jeffrey A. Cohen

Research output: Contribution to journalArticleAcademicpeer-review

5 Citations (Scopus)

Abstract

Background: 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. Objectives: To identify best practices for FO-DMT development and use by agreeing on principles and consensus statements through appraisal of published evidence. Methods: 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. Results: 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. Conclusion: 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.
Original languageEnglish
Pages (from-to)2177-2189
Number of pages13
JournalMULTIPLE SCLEROSIS JOURNAL
Volume28
Issue number14
Early online date2022
DOIs
Publication statusPublished - Dec 2022

Keywords

  • Biosimilar
  • consensus
  • disease-modifying treatments
  • expert opinion
  • guidelines
  • interchangeability
  • multiple sclerosis
  • non-biological complex drugs
  • switching

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