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Ethical use of Off-label disease-modifying therapies used in MS

August 3, 2021 | Education, Treatments, Uncategorised

The MS International Federation’s Atlas of MS showed that off-label disease-modifying therapies are used in at least 89 countries. This highlights the need for  transparent evidence-based guidelines to support clinical decision-making, pharmaceutical policies and reimbursement decisions.  Because there has been much debate about this, MSIF decided one of the first steps had to be a paper setting out the ethical case for considering the use of off-label treatment.

The first scientific article on MSIFs work on off-label disease-modifying therapies –   “Ethical use of off-label disease-modifying therapies for multiple sclerosis” has now been published in the MS Journal  https://journals.sagepub.com/doi/full/10.1177/13524585211030207 . The article is open access and can be accessed for free.

The authors are Joanna Laurson-Doube (who leads MSIFs access work), Brenda Banwell (the chair of the International Medical and Scientific Board, IMSB), Nick Rijke (the former Deputy CEO of MSIF), Anne Helme (Head of Research and Access), Bernard Hemmer (former chair of ECTRIMS), Bassem Yamout (chair of MENACTRIMS), Shanthi Viswanathan (a neurologist from Malaysia) and Peer Baneke (MSIFs current CEO).

In the article they 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.

The principles and process are endorsed by the World Federation of Neurology (WFN), American Academy of Neurology (AAN), European Academy of Neurology (EAN), and the key international organisations in MS.