Essential medicines for MS

We believe MS is a global health concern. That’s why we advocated for the addition of MS treatments to the World Health Organization’s Essential Medicines List.

Unequal access to MS treatments

Very effective treatments, or disease modifying therapies (DMTs), exist to manage MS. DMTs aren’t a cure for MS but they can reduce relapses and future disability. MS is a complex disease, so it’s important to have a range of DMTs available for people with MS to consider the benefits and risks of different approaches.

20 different DMTs have been approved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for MS as of 2023. Yet access to DMTs is not universal. Access to MS treatment is subject to a country’s healthcare system and whether someone can pay for services. The Atlas of MS shows that in 70% of countries people with MS face barriers in accessing DMTs. Accessing the right MS treatment depends on whether:

• people have access to healthcare
• the healthcare system will pay for MS care (e.g. diagnosis and treatment)
• a range of DMTs are available and covered by the healthcare system
• there is a continuous and reliable provision of treatment.

It is vital for people with MS to get the right treatment at the right time. That’s why we wanted MS DMTs to be added to the WHO Essential Medicines List (EML).

Sanae and her daughter outside their home in Fes, Morocco.

Sanae from Morocco faces financial challenges when she tries to access MS healthcare.

“To even get my diagnosis I had to borrow money from others. I did not have enough money to get treatment. I was devastated. I saw my whole career diminishing. The financial resources did not exist to support it.”

The WHO Essential Medicines List

The World Health Organisation’s Essential Medicines List (EML) has a key role in improving access to medicines globally. Essential medicines are those that that are needed as a minimum to satisfy the priority health care needs of a population. The WHO EML is revised every two years by a committee of global experts, and used as a guide by many countries around the world to prioritise medicines.

Until 2023, the WHO EML listed no MS treatments, and very few medicines for neurological conditions. Thanks to our efforts together with many partners around the world, rituximab, cladribine and glatiramer acetate are now listed on the EML for treating MS. MSIF and its members 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. You can read more about this landmark decision here.

Listing MS DMTs on the WHO EML creates a tool for awareness-raising and advocacy regardless of whether a country has an effective national EML or not. It is a WHO-level stamp of approval, moving the conversation from whether MS DMTs should be made available to how to make them available in low-resource settings.

Importantly, the listing of any MS DMTs on the WHO EML shows that the WHO recognises the public health need for effective and affordable treatments for multiple sclerosis. With this decision, WHO underlines the importance of treating MS. This gives a message of hope for people with MS around the world – opening up opportunities for improved access to MS healthcare. Every country now needs to ensure people with MS can access a range of MS treatments at all times.

MSIF has been working to make this happen for many years. This milestone would not have happened without crucial involvement of our Member Organisations, many dedicated individuals, as well as TRIMS and neurological organisations across the world. Together with our collaborators, we are making a real difference in the lives of people with MS.

Our first application to the EML

In 2018 MSIF applied to add three MS DMTs to the WHO EML, but these treatments were not added to the list. The WHO Expert Committee acknowledged the public health burden of MS, the need for effective and affordable MS medications, and the high volume of letters received in support, but requested a revised application. You can read about the 2018 application process here.

2022 application to the EML

MSIF, in collaboration with the WHO Collaborating Centre Bologna, developed a new application with the help of two independent panels: the MSIF Off-Label Treatments panel (MOLT) and MSIF Essential Medicines Panel (MEMP). Both panels were independent, multi-disciplinary and had international representation. Importantly, the panels included people affected by MS from Uruguay, Serbia, Namibia and Morocco. We also partnered with the Cochrane MS group and McMaster GRADE Centre during this process, both groups being internationally regarded as experts in the field of evidence reviews and decision-making. You can find links to the Cochrane reviews underpinning the work on their website.

The panels were tasked with reviewing DMTs for MS: all DMTs that have regulatory approval, as well as some DMTs that are used ‘off-label’. The panels considered DMTs for relapsing and progressive MS, and also took into account the needs of special populations, including adolescents, and pregnant or breast-feeding women.

During the meeting of the EML Expert Committee, our application was highlighted as an example of exceptional quality and rigour. We also delivered a statement to the committee on behalf of a group of global and regional neurological organisations, emphasising that a decision to list neurological medicines would initiate a paradigm shift in access to treatment for neurological disorders, enabling us to work towards improving the lives of millions of people across the world.

The Lancet Neurology highlighted MSIF’s application in their March Editorial

‘Approval by WHO of the MSIF application will be a crucial first step to ensure that people with multiple sclerosis will be able to access appropriate treatment options in LMICs’

Read the editorial here.

Fifteen organisations endorsed the application:

• World Federation of Neurology (WFN)
• African Academy of Neurology (AFAN)
• Indian Academy of Neurology (IAN)
• European Academy of Neurology (EAN)
• American Academy of Neurology (AAN)
• Neurology Society of Ghana (NSG)
• Neurological Association of Zambia (NAZ)
• Nigerian Society of Neurological Sciences (NSNS)
• Neurological Society of Kenya (NSK)
• Neurology Association of South Africa (NASA)
• Middle East and North Africa Committee for Treatment and Research in Multiple Sclerosis (MENACTRIMS)
• Pan-Asian Committee for Treatment and Research in Multiple Sclerosis (PACTRIMS)
• Latin American Committee for Treatment and Research in Multiple Sclerosis (LACTRIMS)
• Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS)
• European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)

Developing our application to the Essential Medicines List

In this ECTRIMS podcast, Nick Rijke International Consultant for MSIF, and Deanna Saylor of Johns Hopkins Hospital, discuss our application to add MS DMTs to the WHO’s Essential Medicines List.

In the video below, Nick Rijke explains the process we went through when developing the WHO EML application.

FAQs

Find answers to the most frequently asked questions about our application to add MS treatments to the WHO EML.

Learn more about MSIF’s work on access to MS healthcare

Applying to add DMTs to the WHO EML is only one route of improving access to MS treatments. MSIF will continue working to gain access to safe, effective and affordable treatment for everyone, especially in low-resource settings. You can learn more about our work here.