WHO publishes updated essential medicines lists to advance access to vital treatments globally

SWITZERLAND —The World Health Organization (WHO) has released the latest editions of the Model Lists of Essential Medicines (EML) and Essential Medicines for Children (EMLc), unveiling a breakthrough in healthcare access.

The 24th WHO Expert Committee on the Selection and Use of Essential Medicines convened at WHO Headquarters in Geneva from 24 to 28 April 2023.

Thoroughly evaluating 85 applications, the Expert Committee’s recommendations culminated in the addition of 24 new medicines for adults, 12 for children, and new uses for 16 already-listed medicines.

These updated lists feature crucial new medicines to address multiple sclerosis, cancer, infectious diseases, cardiovascular conditions, and more.

With a focus on clinical benefits, these additions aim to revolutionize public health while safeguarding the budgets of low- and middle-income countries.

Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, emphasized the importance of the Essential Medicines List, which has guided countries worldwide for over four decades.

“For over 40 years, countries all over the world have relied on the WHO Essential Medicines List as a definitive, evidence-based guide to the most important medicines for delivering the biggest health impact,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

Rising drug prices and disruptions in supply chains have raised challenges in ensuring consistent and equitable access to essential medicines.

Dr. Tedros noted that: “Rising prices and supply chain disruptions mean that all countries now face increasing problems in ensuring consistent and equitable access to many quality-assured essential medicines. WHO is committed to supporting all countries to overcome these obstacles to increase access with equity.”

The 2023 update underwent a rigorous evaluation, considering 85 applications encompassing over a hundred medicines and formulations. As a result, the EML and EMLc now boast a total of 502 and 361 medicines, respectively.

Bringing hope to people with MS worldwide

One notable inclusion in the updated lists addresses the treatment of multiple sclerosis (MS), a chronic and debilitating nervous system disease affecting millions globally.

For the first time, three medicines—cladribine, glatiramer acetate, and rituximab—have made their way to the EML.

This breakthrough fills a significant gap in MS treatment options, and their varying routes of administration and prices aim to improve global access.

Notably, the off-label use of rituximab received strong support, potentially leading to major health benefits worldwide.

The EML serves as a vital tool for achieving universal health coverage, guiding governments, health facilities, and procurers towards the most beneficial medicines for individuals and communities.

The list includes medicines based solely on solid evidence of safety and efficacy, regardless of on-label alternatives.

For instance, rituximab, with its increasing affordability and availability of prequalified biosimilars, was prioritized over on-label alternatives for essential MS treatment.

Furthermore, fixed-dose combinations of multiple medicines, known as ‘polypills,’ for preventing heart and blood vessel diseases have been added to the EML for the first time.

Scientists from multiple countries conducted milestone trials confirming the benefit of these combinations for both primary and secondary prevention of heart disease.

In the realm of infectious diseases, the new list includes ceftolozane + tazobactam, a ‘reserve’ group antibiotic effective against multi-drug resistant bacteria.

Additionally, medicines like pretomanid, ravidasvir (in combination with sofosbuvir) for chronic hepatitis C, and monoclonal antibodies for Ebola virus disease now offer enhanced treatment options.

The updated list also features two new cancer treatments, pegylated liposomal doxorubicin for Kaposi sarcoma and pegfilgrastim to reduce the toxic effects of certain cancer medicines on the bone marrow.

Extending indications for several cancer medicines for children now encompass new types of childhood cancers.

The listings for human insulin on the EML and EMLc have received an upgrade, extending to include cartridge and pre-filled pen delivery systems.

These new additions offer patients numerous advantages, such as ease of use, accurate dosing, and improved adherence.

A comprehensive review of medicines for mental health and behavioral disorders has led to crucial updates in the EML and EMLc.

To align with WHO guidelines, two new medicines—acamprosate and naltrexone—have been added to treat alcohol use disorder.

Updates have been meticulously made to the formulations of over 70 medicines on the EMLc, ensuring appropriate dosage forms and strengths for children aged up to 12 years are now included.

Notably, the EMLc now features ready-to-use therapeutic food for treating severe acute malnutrition in infants and children up to 5 years old.

Applications not recommended

While numerous medicines have earned their place on the essential lists, the Expert Committee was diligent in scrutinizing applications.

A total of 32 applications were not recommended, including treatments for weight loss in obesity, spinal muscular atrophy, dementia due to Alzheimer’s disease, lymphoma, and fast-acting oral transmucosal fentanyl for breakthrough cancer pain.

Launched in 1977 to improve access to medicines in developing countries, the WHO Model Lists have become a global policy tool for decisions related to medicine selection and universal coverage within health systems.

Over 150 countries rely on these lists to make informed choices on medicines, based on evidence and health impact.

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