On Wednesday, 26 July 2023, the World Health Organisation (WHO) added disease modifying-therapies (DMTs) for multiple sclerosis (MS) onto its Essential Medicines List (EML) for the first time. With this landmark decision, the WHO emphasises the critical need to make MS treatments available in all health systems at all times.
The European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) was one of the organisations that endorsed the application prepared by the Multiple Sclerosis International Federation (MSIF) and the WHO Collaborating Centre Bologna to add MS disease-modifying therapies to the WHO Essential Medicine List.
The three treatments added onto the WHO Essential Medicines List are rituximab, cladribine and glatiramer acetate. MSIF and ECTRIMS stress that the three medicines listed provide a baseline of care, but are not the only ones that are effective and important for the treatment of MS. There is global consensus that a range of MS treatments should be available in all health systems at all times. As this is the first time that MS treatments are included, a new section has been created on the list underlining the importance of treating MS.
Effective treatments are crucial to help people with MS, slowing the accumulation of disability, reducing the number of relapses and maintaining independence. Access to a range of DMTs can help people with MS remain in the workforce and actively contribute to society. MS is a complex disease and it is important that different DMTs are made available to suit the needs of the MS population in a country.
Together with its members, MSIF has been advocating for the inclusion of MS treatments on the Essential Medicines List. The WHO’s Essential Medicines List is an internationally recognised set of selected medicines to help countries choose how to treat their priority health needs. Countries frequently use the list to develop their own national lists of essential medicines.
In December 2022, MSIF in collaboration with the WHO Collaborating Centre Bologna, applied to add MS treatments to the World Health Organisation’s Essential Medicines List (EML). This was the result of many years of effort from MS experts across the globe, who undertook a rigorous review of all DMTs for MS to develop recommendations for the application This work was supported by the Cochrane MS group and McMaster GRADE Centre, both groups being internationally regarded as experts in the field of evidence reviews and decision-making.
The application was made with the help of two independent panels and endorsed by 15 organisations, including all regional MS research and clinical networks (TRIMS), regional and national neurological academies and the World Federation of Neurology.
This is a great moment for the MS community to celebrate this major step forward for all people with and affected by MS around the world and is a testament to the power of international collaboration.
The World Health Organisation’s decision to include disease-modifying therapies (DMTs) for MS in the essential medicines list (EML) is a monumental step in the fight against MS, signalling a new era of accessibility for patients worldwide. By extending the reach of disease-modifying therapies to low- and middle-income countries, this decision promises to transform the lives of countless individuals who have long struggled to obtain adequate MS treatment.
Mar Tintoré; ECTRIMS President
This decision is a major milestone for people affected by MS everywhere. We are delighted that the WHO Expert Committee has recognised the importance of including MS treatments on the Essential Medicines List. It is vital for people with MS to get the right treatment at the right time. MSIF and its member organisations around the world believe that the provision of the types of DMT represented by those on the list is the minimum for adequate MS care. Every country now needs to ensure people with MS can access a range of MS treatments at all times.
Peer Baneke; CEO of Multiple Sclerosis International Federation (MSIF)
DMTs added to the WHO’s Essential Medicines List
The decision about which treatments to include in the application focused on DMTs in low-resource settings and considered the following factors:
- Balance of benefits and harms
- Certainty of the evidence
- Cost and cost-effectiveness in low-resource settings
- Values, equity, acceptability, feasibility and availability (particularly in low-resource settings)
- The needs of special populations – pregnancy, breastfeeding and paediatric MS
It was not feasible to propose all DMTs suitable for treating MS, and the panel had to recommend only a very restricted number of prioritised DMTs. Countries are free to consider which DMTs should be listed on their national list, depending on the local context, barriers and opportunities. The WHO’s Essential Medicines List is a model list that can be adapted to the local situation.
The treatments included on the WHO’s Essential Medicines List are:
- Rituximab: this is an anti-CD20 medication, administered by infusion, that has been used off-label in the treatment of MS for more than two decades. In low-resourced settings, rituximab offers several advantages. It is highly efficacious and suitable across a broad range of disease presentations, including paediatric MS. While currently contraindicated during pregnancy, women’s MS experts around the world have used rituximab to provide effective disease management in relation to family planning. Emerging data also suggests safety during breastfeeding. Rituximab is already listed on the WHO EML, is widely available and listed on many national EMLs, and has a lower price across different income settings.
- Cladribine: is an oral medication for the treatment of RRMS and active SPMS in adults. Cladribine offers several advantages in low-resourced settings, as it requires only 16-20 days of total treatment distributed over 2 years, and further treatment is not needed for at least another two years. This significantly reduces the likelihood of treatment disruptions in settings where medication supplies can be erratic. While it is contraindicated to use cladribine during pregnancy and breastfeeding, it may be used to plan around pregnancies given its infrequent dosing. Limitations in low-resourced settings include that people with HIV and TB, as well as pregnant and breastfeeding women and men and women of childbearing age who do not have access to reliable contraception, cannot use this therapy.
- Glatiramer acetate: is a treatment for RRMS administered by subcutaneous injection. It has been used off-label in clinical practice in paediatric MS for over twenty-five years. Glatiramer acetate offers several advantages in low-resourced settings, including its lack of monitoring requirements, good safety profile without risk of opportunistic infections, and safety in women of childbearing age, pregnant and breastfeeding women, and paediatric populations. The major drawbacks to its use in these settings are its non-preferred administration route (i.e. injections) and its refrigeration requirement.
Find answers to the most frequently asked questions about the application to add MS treatments to the WHO EML.
An important milestone for neurological disease
Treatments for neurological conditions have been underrepresented on the WHO’s Essential Medicine List. In the recent intersectoral global action plan on epilepsy and other neurological disorders, developed by the WHO and adopted by its member states, the WHO calls for the updating of the Essential Medicines List to ensure it is appropriate for neurological conditions. The addition of MS treatments in 2023 sends a strong signal that the treatment needs of people living with neurological conditions must be prioritised by countries across the world.
The European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) is the leading European organisation dedicated to the understanding and treatment of multiple sclerosis (MS). ECTRIMS promotes and fosters multidisciplinary research and education in MS and provides a platform for communication, collaboration, and dissemination of knowledge among healthcare professionals.
The Multiple Sclerosis International Federation (MSIF) is a unique movement made up of 47 MS organisations with links to many others around the world. MSIF and its members campaign for increased awareness of MS, support scientific research and improve access to treatments and healthcare. Through organisational development, campaigning and information resources, MSIF supports and collaborates with organisations in countries where there is limited provision for people with MS.
For media inquiries, please contact:
Naomi Smith; Communications and Marketing Manager | ECTRIMS