Polypills among treatments added to WHO list

Polypills are among drugs added to the World Health Organization’s essential medicines list, it has been announced.

WHO has produced its new editions of the Model Lists of Essential Medicines (EML) and Essential Medicines for Children (EMLc), with new medicines for several diseases and conditions.

For the 2023 update, the WHO Expert Committee on Selection and Use of Essential Medicines examined 85 applications for inclusion, encompassing more than 100 medicines and formulations.

Of those 32 were not recommended.

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 EML and 48 medicines on the EMLc have been added.

The changes recommended by the expert committee bring the number of medicines to 502 on the EML and 361 on the EMLc.

The new applications are for the treatment of multiple sclerosis, cancer, infectious diseases, and cardiovascular conditions, among others and the committee said the updated lists could have a very large public health impact globally without jeopardising the health budgets of low- and middle-income countries.

Dr Tedros Adhanom Ghebreyesus, WHO Director-General, said: “For over 40 years, countries all over 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.

“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.”

Among the recommendations to be included in the new list were cladribine, glatiramer acetate and rituximab, which can be administered to delay or slow down the progression of multiple sclerosis (MS). The off-label use of rituximab is supported by strong evidence of its efficacy and safety for this indication.

Fixed-dose polypills, including cholesterol-lowering agents with one or more blood pressure lowering agents with and without aspirin, to prevent diseases of the heart and blood vessels have been added to the EML for the first time.

For infectious diseases, new medicines listed include: ceftolozane + tazobactam, a ‘reserve’ group antibiotic effective against multi-drug resistant bacteria; pretomanid for treatment of multidrug-resistant or rifampicin-resistant tuberculosis; ravidasvir (to be used in combination with sofosbuvir) for the treatment of chronic hepatitis C virus infection in adults; and monoclonal antibodies for Ebola virus disease.

Two new cancer treatments have been added: pegylated liposomal doxorubicin for Kaposi sarcoma and pegfilgrastim to stimulate 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 anaplastic large cell lymphoma, Langerhans cell histiocytosis and Burkitt lymphoma.

For diabetes, current listings for human insulin on the EML and EMLc are extended to include cartridge and pre-filled pen delivery systems, while for mental health conditions, a comprehensive review 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 acamprosate and naltrexone to treat alcohol misuse.

Updates to the children’s list included formulations of more than 70 medicines 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 five years old.

Dr Benedikt Huttner, secretariat of the WHO EML, said: “The List is an important tool for achieving universal health coverage, providing guidance to governments, health facilities and procurers on which medicines are the best value in terms of benefits for individuals and communities.

“The EML includes medicines only on the basis of solid evidence for safety and efficacy. Approved indications within national jurisdictions or the availability of on-label alternatives is not a decision criterion.

“Given the evidence base and the increased affordability of rituximab, including the availability of prequalified biosimilars, it has been prioritised over on-label alternatives as an essential medicine to treat relapsing-remitting and progressive MS.”

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