By Sharon Atieno

The World Health Organization (WHO) has published new medicines for the treatment of multiple sclerosis, cancer, infectious diseases, and cardiovascular conditions, among others in its updated essential medicine lists.

These lists include the Model Lists of Essential Medicines (EML) and the Essential Medicines for Children (EMLc).

Multiple sclerosis (MS), a chronic, debilitating disease of the nervous system affects 2.8 million people worldwide yet no medicines for its treatment were included in the EML.

Currently, three medicines that can delay or slow its progression – cladribine, glatiramer acetate and rituximab – have been added to the list.

For cardiovascular diseases, the fixed-dose combinations of multiple medicines (commonly called ‘polypills’) for the prevention of diseases of the heart and blood vessels, notably cholesterol-lowering agents with one or more blood pressure-lowering agents with and without aspirin was added to the list for the first time.

Based on recommendations by previous EML Expert Committees, scientists from multiple countries conducted milestone trials confirming the benefit of these combinations for both primary and secondary prevention of heart disease.

Several medicines have been listed for infectious diseases. Among them is the ceftolozane plus tazobactam, a ‘reserve’ group antibiotic effective against multi-drug resistant bacteria, including difficult-to-treat infections caused by carbapenem-resistant Pseudomonas aeruginosa.

Pretomanid has been added for the treatment of multidrug-resistant or rifampicin-resistant tuberculosis.

While ravidasvir (to be used in combination with sofosbuvir) has been included for the treatment of chronic hepatitis C virus infection in adults, monoclonal antibodies have been added for Ebola virus disease.

Two new cancer treatments have been added: pegylated liposomal doxorubicin for Kaposi sarcoma and pegfilgrastim to stimulate the production of white blood cells and reduce the toxic effect of some cancer medicines on the bone marrow.

The indications for several cancer medicines for children already included on the EMLc were extended to include new types of childhood cancers (anaplastic large cell lymphoma, Langerhans cell histiocytosis and Burkitt lymphoma).

Additionally, those not recommended for inclusion encompass several patented, highly-priced cancer medicines because of concerns about affordability and feasibility in low-resource settings.

Some of these had been evaluated and rejected during past Committee meetings – PD-1 / PD-L1 immune-checkpoint inhibitors and osimertinib for lung cancers, and CDK4/6 inhibitors for breast cancer.

With regards to diabetes, the current listings for human insulin on the EML and EMLc are extended to include cartridge and pre-filled pen delivery systems due to their potential advantages for patients over vials and syringes in terms of ease of use, greater accuracy of dosing and improved adherence.

Also, a comprehensive review of medicines for mental health and behavioral disorders has led to updates to the EML and EMLc to ensure strong alignment between the Model Lists and recommendations in WHO guidelines, including the addition of two new medicines – acamprosate and naltrexone – for treatment of alcohol use disorder.

Updates were made to listed formulations of over 70 medicines in the EMLc to ensure appropriate dosage forms and strengths for use in children aged up to 12 years are included. Ready-to-use therapeutic food is added to the EMLc for the treatment of severe acute malnutrition in infants and children up to 5 years old.

The updated Essential Medicines Lists include 24 new medicines for adults and 12 new medicines for children and specify new uses for 16 already-listed medicines. New formulations of 19 medicines on the Model Lists of Essential Medicines (EML) and 48 medicines on the Essential Medicines for Children (EMLc) have been added.

The recommended changes by the WHO Expert Committee on Selection and Use of Essential Medicines bring the total number of medicines on the EML and EMLc to 502 and 361, respectively.

A total of 32 applications were not recommended including glucagon-like peptide-1 receptor agonists for weight loss in obesity, risdiplam for the treatment of spinal muscular atrophy, donepezil for the treatment of dementia due to Alzheimer’s disease, CAR-T cell therapies for lymphoma and fast-acting oral transmucosal fentanyl for breakthrough cancer pain.

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

“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 Model Lists are updated every two years by an Expert Committee, made up of recognized specialists from academia, research and the medical and pharmaceutical professions, to address new health challenges, prioritize highly effective therapeutics and improve affordable access.

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