Improving global access to an effective MS treatment

Oumaima Benaiche receiving her infusion treatment in hospital Fes, Morocco.

A new publication led by MSIF and its collaborators outlines evidence-based recommendations for the off-label use of rituximab for treating MS in low-resource settings. This offers practical guidance for healthcare professionals and policy makers to improve treatment options for people with MS, where licensed disease-modifying therapies (DMTs) are unavailable or unaffordable.

Read the publication: Recommendations for the use of off-label rituximab for the treatment of multiple sclerosis in low-resource settings.

From data collected through the Atlas of MS – and from what people with MS around the world tell us – we know that many thousands of people with MS lack access to highly effective DMTs. This is for a variety of reasons – certain MS treatments may not be available in a country, or they can be too expensive.

Rituximab is a similar type of drug to other DMTs which are approved for MS. It is already used in many countries as an ‘off-label’ treatment, and is often available at lower cost than some approved therapies. ‘Off-label’ DMTs have regulatory approval for another disease but are used to treat MS, often when ‘on-label’ treatment options are limited. The Atlas of MS found that 87% of countries use off-label DMTs , with rituximab being the most commonly used.

Evidence-based recommendations can help healthcare professionals decide whether to offer rituximab as a treatment for MS. An international panel comprising people with MS, representatives from MSIF member organisations, as well as healthcare professionals, MS researchers and policy experts, was brought together by MSIF in 2021. The panel was supported by the Cochrane MS group who led the research work, and the complex methodology was led by members of the McMaster GRADE Centre. After a thorough review of all the evidence from clinical trials and other studies on rituximab as a treatment for MS, the panel developed recommendations on its use.

What are the recommendations?

Rituximab is recommended as a treatment for MS, whether as a first treatment that someone with MS receives, or when switching from another treatment. The panel concluded that rituximab compares favourably to other MS treatments, for relapsing and some progressive forms of MS.

The recommendations also provided some practical guidance for clinicians, and emphasised the importance of shared decision-making between the clinician and person with MS when deciding whether to use rituximab.

Why is this important for low-resource settings?

Panel members were particularly interested in considering whether there are benefits of using rituximab in low resource settings. Because rituximab is used to treat other conditions (such as some blood cancers and rheumatoid arthritis) it is often already available in countries.  It is relatively low cost compared with some other MS treatments, and there are biosimilar versions, which can lower the cost even further. Treatment is only every 6 months which can ease the burden on the health system and the individual who has to travel to a treatment centre. Overall, rituximab is acceptable to people with MS, and its increased use may improve global health equity.

These recommendations relate to the addition of MS treatments to the WHO’s Essential Medicines List (EML). The evidence underpinning the recommendations also helped ensure that rituximab (along with cladribine and glatiramer acetate) were listed on the EML for treating MS. This decision is already leading to improved access to MS treatment for people with MS in some countries, including Nepal and the UAE.

Call for further research

One of the challenges is that the available research evidence is not very strong or high quality, meaning that the recommendations are described as having ‘low certainty’. There is a need for larger, high quality randomised controlled trials comparing rituximab with other available treatments for MS. There are a few clinical trials currently taking place, with results due in the next couple of years.

How can you use these recommendations?

This publication can be used by policymakers, patient advocacy groups, healthcare workers, and people with MS. These recommendations aim to help more people with MS get access to an effective treatment.

• The recommendations could contribute to the development of standards of MS care, being adapted as needed when creating local or national treatment guidelines.
• The recommendations can provide the evidence underpinning advocacy activity aimed at making rituximab more accessible, funded and reimbursed, by demonstrating that rituximab is an effective and safe treatment for MS.
• Together with the related publication on recommendations for essential medicines in low-resource settings, this publication can be used to prioritise MS in health systems by drawing attention to the global expert agreement that MS should be treated in all settings.

Visit this webpage for a helpful starting point to explore different advocacy approaches and get inspired by the examples within the MS movement.