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WHO has endorsed groundbreaking public health measures concerning novel Essential Medicines for the treatment of multiple sclerosis.
In a momentous development, the World Health Organization (WHO) has unveiled the latest editions of Essential Medicines List (EML) and Essential Medicines for Children (EMLc), featuring crucial innovative drugs to relieve multiple sclerosis (MS). The newly updated model lists have been expanded to include revolutionary medicines for MS. This expansion aims to enhance worldwide access to innovative medicines that offer clear clinical benefits. These additions to the list have the potential to remarkably improve public health globally, all while preserving the financial resources of low- and middle-income countries.
Dr. Tedros Adhanom Ghebreyesus (WHO Director-General) focused on the significance of these lists. For more than forty years, nations worldwide have depended on the WHO Essential Medicines List as an authoritative and evidence-backed reference for the most critical medications that can have the most significant influence on public health. Escalating prices and disruptions in the supply chain have created mounting challenges for all nations in ascertaining consistent and equitable access to quality-assured Essential medicines. WHO is fully committed to aiding all nations in overcoming these obstacles to expand access with fairness.
To arrive at the 2023 update, the WHO Expert Committee on Selection and Use of Essential Medicines examined 85 applications, encompassing over 100 drugs and formulations. The suggested alterations have expanded the number of agents on the EMLc and EML to 361 and 502, respectively. One of the standout additions to the Essential Medicines List is the inclusion of medicines for MS. It is a chronic and debilitating nervous system disorder that worldwide impacts approximately 2.8 million people.
Remarkably, this is the first time that agents for MS have been incorporated in EML. In the year 2023, three medicines, namely Cladribine, Glatiramer acetate, and Rituximab, have been annexed to the list. These agents can retard or slow MS advancement, addressing a significant gap in the treatment options available for this widespread condition. The inclusion of these medicines, each with different routes of administration, varied pricing (including generics and biosimilars), and diverse recommended uses, aims to enhance global access to MS management. The choice to endorse the off-label utilization of Rituximab is rooted in robust evidence confirming its safety and effectiveness in managing MS, consistent with prior recommendations made by the Expert Committee.
This recommendation has the potential to bring substantial health benefits to individuals worldwide. Dr. Benedikt Huttner (Secretariat of WHO EML) highlighted the significance of the Essential Medicines List as a tool to attain universal health coverage, yielding guidance to governments, health facilities, and procurers on the best-value therapeutic agents for individuals and communities. The EML encompasses agents exclusively based on substantial evidence of their safety and effectiveness, without taking into account approved uses specific to national regulations or the availability of on-label substitutes.
Therefore, Rituximab has been given precedence over officially indicated alternatives as an Essential Medicine for the management of relapsing-remitting and progressive MS, owing to its solid foundation of evidence and improved affordability, which includes the presence of prequalified biosimilars. The inclusion of these Essential Medicines for MS marks a groundbreaking advancement in the fight against this debilitating disease, offering hope and improved access to treatment for people living with MS worldwide.
WHO
WHO endorses landmark public health decisions on Essential Medicines for Multiple Sclerosis
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