WHO’s Landmark Decision for Multiple Sclerosis Treatments
Overview of the Meeting
During its 24th meeting in Geneva from April 24 to 28, 2023, the World Health Organization (WHO) Expert Committee made a significant advancement for patients with multiple sclerosis (MS). For the first time, treatments for MS were included in the Model Lists of Essential Medicines (EML).
What is the EML?
The EML is a compilation of the most effective and safe medications for various illnesses. It serves as a crucial reference for government agencies worldwide when making decisions about drug procurement, health budgeting, and prescribing practices. More than 150 countries utilize the WHO’s EML to shape their national lists of essential medicines.
Implications for MS Patients
With the WHO’s endorsement, there is growing optimism among MS patients and healthcare providers for improved access to effective treatments. MS Canada, a Canadian non-profit organization that connects individuals living with MS to resources and research, remarked, “The WHO decision formally acknowledges multiple sclerosis as a global healthcare priority. The WHO EML provides countries with an evidence-based advocacy tool to achieve, increase, and improve access to disease-modifying therapies (DMTs) in low-middle-resource countries.” MS Canada, as part of the Multiple Sclerosis International Federation, contributed to the application that led to this pivotal milestone for the MS community.
WHO-Recommended MS Treatments
Understanding Multiple Sclerosis
Multiple sclerosis is an incurable autoimmune disease characterized by the immune system attacking neurons. Current treatments focus on alleviating symptoms and slowing disease progression. The WHO has recommended three treatments in the EML: cladribine, glatiramer acetate, and rituximab, all classified as disease-modifying therapies (DMTs). These therapies work by suppressing the immune cells that harm the central nervous system.
Cladribine
Cladribine is approved for treating highly active relapsing-remitting multiple sclerosis. It selectively targets two types of lymphocytes (T and B) that attack the myelin in the brain, unlike some other MS medications that suppress the entire immune system. Cladribine has been shown to reduce relapses by 58% and decrease the risk of worsening disability by 33%.
Glatiramer Acetate
As one of the oldest MS drugs, glatiramer acetate is typically the first medication prescribed to patients with active relapsing multiple sclerosis. Its mechanism is similar to that of cladribine, but it poses a higher risk of infections due to its broader immune system effects. Glatiramer acetate decreases relapse rates by 34% and reduces the likelihood of clinically isolated syndrome progressing to MS by 40%.
Rituximab
Rituximab’s inclusion in the EML is particularly noteworthy, as it is not officially approved by regulatory authorities for MS treatment. However, it has shown good efficacy and safety in clinical trials and is often used off-label in many countries. Dr. Benedikt Huttner, Secretariat of the WHO EML, stated, “Given the evidence base and the increased affordability of rituximab, including the availability of prequalified biosimilars, it has been prioritized over on-label alternatives as an essential medicine to treat relapsing-remitting and progressive MS.”
Response from MS Societies
Recognition of the WHO’s Decision
The American National Multiple Sclerosis Society commended the WHO for this decision while emphasizing the need for further expansion of the list. Their official statement noted, “While there are far more DMTs available in some parts of the world, including these DMTs on the EML list is a significant action towards equitable access around the world.” They also highlighted the importance of rituximab’s inclusion, stating that “off-label DMTs can also be an important intervention for disease modification and may be more readily available and affordable in other health systems, especially in low-resource settings.”
References
1. World Health Organisation. WHO endorses landmark public health decisions on Essential Medicines for Multiple Sclerosis. Accessed September 20, 2023. https://www.who.int/news/item/26-07-2023-who-endorses-landmark-public-health-decisions-on-essential-medicines-for-multiple-sclerosis
2. Cladribine (Mavenclad) | MS Society. www.mssociety.org.uk. Accessed September 20, 2023. https://www.mssociety.org.uk/about-ms/treatments-and-therapies/disease-modifying-therapies/cladribine
3. Glatiramer acetate Copaxone | Multiple Sclerosis Society UK. www.mssociety.org.uk. Accessed September 20, 2023. https://www.mssociety.org.uk/care-and-support/resources-and-publications/publications-search/glatiramer-acetate-copaxone
4. National MS Society. Multiple Sclerosis Coalition Applauds World Health Organization Decision. National Multiple Sclerosis Society. Published July 26, 2023. Accessed September 21, 2023. https://www.nationalmssociety.org/About-the-Society/News/Multiple-Sclerosis-Coalition-Applauds-World-Health