In today’s editions of the Model Lists of Essential Medicines (EML) and Essential Medicines for Children (EMLc), the World Health Organization (WHO) has included significant new medications for the treatment of multiple sclerosis, cancer, infectious diseases, and cardiovascular conditions, among other conditions. The revised Model Lists are meant to make novel drugs with obvious therapeutic advantages more widely available. Without endangering the health budgets of low- and middle-income countries, these medicines could have a significant worldwide influence on public health.
The WHO Director-General, Dr. Tedros Adhanom Ghebreyesus, stated that “for more than 40 years, countries around the world have relied on the WHO Essential Medicines List as a clear, evidence-based guide to the most important medicines for delivering the biggest health impact.” “All countries currently face growing difficulties in guaranteeing consistent and fair access to many quality-assured vital medicines due to rising pricing and supply chain interruptions. WHO is dedicated to helping all nations overcome these barriers and expand access while ensuring equity.
The WHO Expert Committee on Selection and Use of Essential Medicines evaluated 85 submissions totaling more than 100 medications and formulations for the 2023 update. The total number of medications on the EML and EMLc after the suggested adjustments is 502 and 361, respectively.
The Executive Summary contains comprehensive information about the Expert Committee’s recommendations, including a description of the drugs that were added, changed, or removed, as well as the ones that were not recommended.
A persistent, crippling neurological condition known as multiple sclerosis affects about 2.8 million people worldwide. No medications for its treatment have been listed on the EML up until this point. Cladribine, glatiramer acetate, and rituximab are three medications that potentially halt or decrease the course of the disease that are added to the EML in 2023, filling a critical gap given the significant global burden of MS. In order to promote access to treatment for MS patients worldwide, these medications are listed as MS treatment alternatives with a variety of approved uses, varied pricing (due to the availability of generic and biosimilar versions), and different routes of administration. Strong evidence of rituximab’s effectiveness and safety for this purpose helped to justify the decision to permit off-label usage of the drug.
The List is a crucial resource for obtaining universal health coverage since it advises authorities, medical institutions, and buyers on which drugs offer the greatest value in terms of advantages for people and communities. Only drugs with strong safety and efficacy data are included in the EML. According to Dr. Benedikt Huttner, the Secretariat of the WHO EML, “approved indications within national jurisdictions or the availability of on-label alternatives is not a deciding criterion. “Rituximab has been prioritized over on-label alternatives as an essential medicine to treat relapsing-remitting and progressive MS due to the evidence base and the increased affordability of rituximab, including the availability of prequalified biosimilars.”
For the first time, the EML now includes fixed-dose combinations of multiple drugs (commonly referred to as “polypills”) for the prevention of diseases of the heart and blood vessels, particularly cholesterol-lowering drugs combined with one or more blood pressure-lowering drugs with and without acetylsalicylic acid (aspirin). Scientists from numerous nations completed landmark studies to support the effectiveness of these combinations for the primary and secondary prevention of heart disease based on recommendations made by previous EML Expert Committees.
Pegylated liposomal doxorubicin for Kaposi sarcoma and pegfilgrastim to increase the generation of white blood cells and lessen the toxicity of some cancer medications on the bone marrow are two new cancer treatments that have been added. Anaplastic large cell lymphoma, Langerhans cell histiocytosis, and Burkitt lymphoma were added to the list of pediatric diseases for which certain medications are already approved by the EMLc. Several proprietary, expensive cancer medications are also not advised for inclusion due to concerns about their affordability and viability in low-resource areas. Some of these, such as CDK4/6 inhibitors for breast cancer and immune checkpoint inhibitors PD-1 and PD-L1 for lung malignancies, had previously been considered and rejected by the Committee.
From April 24 to 28, 2023, the 24th meeting of the WHO Expert Committee on the Selection and Use of Essential Medicines was place at WHO Headquarters in Geneva. The Expert Committee reviewed 85 requests for medications to be included on the eighth and 22nd WHO Model Lists of Essential Medicines for Children, respectively. Applications pertaining to their respective disease areas were involved with, and WHO technical divisions were consulted.