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Accessing MS treatment for all: an update into MSIF’s successful WHO Essential Medicines List bid

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During our recent webinar, an international panel of experts recounted the journey undertaken by the Multiple Sclerosis International Federation (MSIF) to include essential MS medications in the World Health Organization (WHO)’s Essential Medicines List (EML).

Dr. Brenda Banwell, the chief of Neurology at the Children’s Hospital of Philadelphia, a professor at the University of Pennsylvania, and the chair of the Medical and Scientific Board of the MSIF, along with Dr. Anne Helme, the head of Research and Access at the MSIF, moderated the discussion.

In 2020, the MSIF updated the epidemiological data and aspects of healthcare in the Atlas of MS. A survey conducted on this occasion revealed important disparities in access to disease-modifying therapies (DMTs) worldwide, with particularly poor access in Africa and low-income countries. Many people with MS struggle to get the healthcare that they need. Dr. Helme pointed out that data collection – fundamental to advocate for changes in healthcare policies – and access to treatment pose major challenges in many countries across the world.

Dr. Juan Ignacio Rojas, an associate professor at the University Hospital of CEMIC and the director of the MS center of the University Hospital of CEMIC and CEMBA in Buenos Aires, offered a perspective on the current difficulties experienced in Argentina.

Dr. Rojas emphasized the fragmentation of the Argentinian healthcare system, mentioning the existence of 300 different social health insurance funds. This segmentation leads to high heterogeneity in healthcare and treatment – especially related to costs – and difficulties in collecting data. In 2018, the first nationwide registry of patients with MS and neuromyelitis optica spectrum disorders (NMOSD), called RelevarEM, was created. Different groups of stakeholders can now collaborate to gather real-world data.

Dr. Ethel Ciampi, an associate professor at the Pontifical Catholic University of Chile and the director of MS and Neuroimmunology Program UC-Christus at the Hospital Dr. Sótero del Río, provided an overview on the healthcare in Chile.

Dr. Ciampi highlighted the important inequalities between the private and the public health systems, which pose major challenges in personalising treatments. Until 2010, only patients who could afford specialised neurological consultations were diagnosed. In 2010, interferon and glatiramer acetate were introduced as the main treatments for patients with MS. Solely patients with private insurance – about half of the total patients – could have access to the full range of DMTs. At this point, clinicians, researchers, and patients’ organisations started to collaborate with the Ministry of Health. They presented real-world data to advocate for access to a larger range of DMTs for all patients. Finally, in 2016, a law was promulgated to guarantee universal access to different high-efficacy therapies to patients who reported treatment failure or severe adverse events associated with previous treatments. In 2019, all the approved DMTs became accessible to patients without any cost.

Dr. Deanna Saylor, an associate professor at the Johns Hopkins University School of Medicine (US) and the director of Neurology Training at the University Teaching Hospital in Lusaka (Zambia), presented an overview of MS healthcare in Zambia. In the entire country of Zambia, there are only 12 neurologists available for almost 20 million people. As a result, finding a clinic and accessing diagnostics is extremely challenging. Furthermore, only rituximab is available to treat patients with MS and covered by the national insurance. While this represents an important advancement compared to the past, there are still no alternatives to rituximab available.

The WHO’s EML is intended to satisfy the priority health care needs of different countries. Until 2023, the list did not include any treatment for MS. This was clearly an important gap to address, especially considering that globally 2.9 million people live with the burden of MS, and individuals from 75% of countries worldwide report encountering barriers to accessing DMTs. The WHO EML is updated every two years by a global panel of experts, including people with MS from different countries.

Dr. Saylor served as the Clinical Chair for the committee that elaborated the recommendations for the revisions made in 2023. The panel of experts and people with MS closely collaborated with the WHO, the Cochrane MS and Rare Disease of the CNS and the McMaster GRADE Center. The panel reviewed the available evidence for all the approved DMTs and off label treatments for MS and evaluated how well they would function in resource-limited settings. Dr. Saylor pointed out that the WHO EML does not list every possible approved treatment for a condition. Therefore, the panel could only put forward two or maximum three DMTs to be included in the list.

Based on systematic reviews, the panel considered various aspects of all the treatments – e.g. benefits and harms, cost-effectiveness, feasibility, required monitoring, needs of paediatric population and safety during pregnancy and breastfeeding. The selection of proposed essential medicines was then circulated for feedback among various MS and neurological organisations from across the globe to obtain wide community support. On the 26th of July 2023, the proposal was accepted by the WHO.

Rituximab, cladribine, and glatiramer acetate were added to the list of essential medicines. The choice of these three medicines was motivated by various considerations. Both rituximab and cladribine do not imply a daily access to medication. Rituximab can be used to treat the paediatric population with MS and emerging data suggest that it is also safe to use during breastfeeding. Glatiramer acetate requires less monitoring than rituximab and cladribine, and can be used to treat paediatric population and during pregnancy and breastfeeding. Furthermore, it has a very low risk of associated infection.

As Dr. Banwell highlighted, “This finally moved the conversation from whether MS treatments should be made available to how to make them available” particularly in limited-resource settings.

The WHO’s decision was a major global milestone. This achievement testifies the importance of a rigorous, evidence-based process, with clear guidelines and the power of a network of global collaborations. International collaboration should now continue between governments, industries, healthcare providers and patients’ organisations to ensure a more affordable access to DMTs.