On 26 July 2023, the World Health Organization (WHO) added three disease modifying-therapies (DMTs) for multiple sclerosis (MS) onto its Essential Medicines List for the first time: rituximab, cladribine and glatiramer acetate. With this decision, the WHO acknowledged the critical importance of making MS treatments available in all health systems at all times. It is a crucial step towards improving access to MS treatments for people living with MS, particularly those in low- and middle-income countries or low-resource settings, who face significant barriers to accessing MS treatments.
The road to the WHO Essential Medicines List
July 2023 was not the first time the MS International Federation and our collaborators from around the world were waiting anxiously for news from the WHO. Four years ago, we had applied to add three MS treatments to the WHO’s Essential Medicines List (EML), but on that occasion, we were not successful. Yet, the WHO encouraged us to reapply in the future.
Knowing the benefits that listing DMTs for MS on the WHO EML could bring, we had to try again. Until now, there have been no treatments for MS listed on the WHO EML, and very few for any neurological condition. Despite the existence of over 30 different licensed and off-label treatments for MS, around 70% of countries across the world report that people with MS face barriers accessing DMTs.
For our second application, we invited additional partners to collaborate with us. The WHO Collaborating Centre Bologna was our co-applicant, and we were also 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. We set up two new independent, multidisciplinary panels, and started a very comprehensive and rigorous review process.
A global, multi-disciplinary effort
The MS International Federation is a global network of MS organizations, people affected by MS, volunteers and staff from around the world. To give the application the best chance of success, we also needed to know that what we were proposing had the support from the global clinical community. We therefore reached out to healthcare professionals with experience of caring for people with MS in low-resource settings, as well as several neurological academies, and the regional Committees for Treatment and Research in MS (TRIMS).
"The WHO decision to include, for the first time, MS medications in their Essential Medicines List (EML) is the culmination of two years of relentless efforts by the MSIF and its partner organizations. Although most approved MS therapies are widely available, people with MS living in certain regions of the world, especially in resource-limited settings, do not have access to much needed therapies that are either unavailable or unaffordable. Inclusion of any medication in the WHO EML is usually associated with increased availability and reimbursement by governmental agencies. The WHO decision to include three MS therapies with different routes of administration, efficacy and tolerability in their updated list will undoubtedly help increase access of people with MS to high quality, cost-effective and evidence-based treatments.”
A message of hope for people with MS around the world
The WHO EML Committee decided to add rituximab, cladribine and glatiramer acetate in a new section of the EML. Although rituximab is not licensed for MS, it has been used to treat MS off-label for over two decades. It is important to note 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.
We know that there are many people living with MS across the world that do not have access to any DMTs, or don’t have the right DMT for their clinical needs, or don’t get the option of high-efficacy DMTs as a first-line treatment. Listing MS treatments on the WHO EML is an important first step, and can support advocacy efforts to tackle these challenges.
“People with MS in lower-resourced settings, including most low- and middle-income countries, often face numerous challenges in their MS journeys. This starts with accessing the specialists and diagnostic tests, including MRIs, required to obtain their diagnosis and continues with accessing effective treatments for their MS. As a result, people with MS in low- and middle-income countries often are untreated, under-treated or have to expend significant personal resources in order to obtain treatment. Based on my own experience taking care of people with MS in Zambia, I am confident that, if DMTs are available, treatment of MS is feasible, safe and likely to be highly effective and result in good outcomes among people with MS in low- and middle-income countries.”
What happens next?
Every country now needs to ensure people with MS can access a range of MS treatments at all times.
First, countries need a good understanding of which treatments are currently used by people with MS, and where the gaps and barriers to access are. Data and evidence are essential in underpinning any advocacy work and making the case for change.
Once the challenges have been identified, local clinicians and patient groups can work together to advocate for the DMTs that are needed and for them to be made available at a cost that is affordable to the health system and the individual.
“There has long been challenges for access to much needed treatments for multiple sclerosis in many regions globally. The recent inclusion in the Essential Medicines List of Medications such as rituximab as off-label options for multiple sclerosis by the WHO is an important step in the recognition of how important it is to provide affordable, accessible and sustainable treatments for patients with MS especially from low- and middle-income countries where resources need to be prioritized carefully. This result, with careful follow-on actions at global, regional and national levels, will definitely have a tremendous impact for people with MS, clinicians and communities within these regions. As a clinician, I look forward to working with my patients nationally and regionally to improve their care with careful monitoring in the future.”
On the MSIF website, you can find more information and resources to support advocacy around access to MS healthcare. We have case studies from different countries that have successfully improved availability and affordability of MS treatments, and guides to getting started in advocacy.
We are also very interested in hearing from anyone who is interested in working to improve access to MS treatments in their country. Our team is available to listen, learn from and support you in relation to advocacy around healthcare challenges. Please get in touch with us at firstname.lastname@example.org.
Anne Helme, PhD is Head of Research and Access at the Multiple Sclerosis International Federation (MSIF), based in London, UK. In this role, she has oversight of MSIF’s participation in global research collaborations, such as the Progressive MS Alliance and the global Patient Reported Outcomes for MS Initiative. In terms of access to healthcare, she works closely with colleagues leading global projects addressing challenges in access to disease-modifying therapies. She believes that globally accessible, comparative data on MS is crucial for advocacy efforts to improve MS healthcare, and is interested in how the development of national registries and MSIF’s Atlas of MS can support this. Anne has a PhD in Zoology, and has previously held research, communications and education roles at scientific and medical charities in the UK.
Joanna Laurson-Doube, PhD, MBA is International Consultant – Access to Healthcare for the Multiple Sclerosis International Federation (MSIF). She is originally from Finland, but grew up in Belgium and studied and worked in the UK for twenty years before moving to Hong Kong. She has a PhD in Cell Biology from University College London and has recently completed an Executive MBA at Kellogg-HKUST. Her work as a consultant for MSIF aims to improve access to treatment for people MS, especially in resource-limited settings. Her role at MSIF is to bring together diverse groups of international experts to shape a global strategy to improve access to disease-modifying therapies. She is engaged in solving systematic issues in global health and feels passionate about enabling international collaborations for broad impact.