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Ethical use of off-label disease-modifying therapies for multiple sclerosis

Laurson-Doube J 1 , Rijke N 1 , Helme A 1 , Baneke P 1 , Banwell B 2 , Viswanathan S 3 Show all authors , Hemmer B 4 , Yamout B 5

Affiliations 

  • 1 Multiple Sclerosis International Federation, London, UK
  • 2 Division of Neurology, Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
  • 3 Department of Neurology, Hospital Kuala Lumpur, Kuala Lumpur, Malaysia
  • 4 Department of Neurology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany/Munich Cluster for Systems Neurology (SyNergy), Munich, Germany
  • 5 Department of Neurology-Nehmeh and Therese Tohmeh Multiple Sclerosis Center, American University of Beirut, Beirut, Lebanon/Neurology Institute, Harley Street Medical Center, Abu Dhabi, United Arab Emirates
Mult Scler, 2021 Aug;27(9):1403-1410.
PMID: 34304636 DOI: 10.1177/13524585211030207

Abstract

BACKGROUND: Off-label disease-modifying therapies (DMTs) for multiple sclerosis (MS) are used in at least 89 countries. There is a need for structured and transparent evidence-based guidelines to support clinical decision-making, pharmaceutical policies and reimbursement decisions for off-label DMTs.

OBJECTIVES/RESULTS: The authors put forward general principles for the ethical use of off-label DMTs for treating MS and a process to assess existing evidence and develop recommendations for their use.

CONCLUSION: The principles and process are endorsed by the World Federation of Neurology (WFN), American Academy of Neurology (AAN), European Academy of Neurology (EAN), Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS), European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), Middle-East North Africa Committee for Treatment and Research in Multiple Sclerosis (MENACTRIMS) and Pan-Asian Committee for Treatment and Research in Multiple Sclerosis (PACTRIMS), and we have regularly consulted with the Brain Health Unit, Mental Health and Substance Use Department at the World Health Organization (WHO).

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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