The WHO gives priority to the approach to the treatment of diabetes and cancer on new lists of essential drugs

The WHO today released a new edition of its Model List of Essential Medicines and Essential Medicines for Children, which includes new treatments for various cancers, insulin analogues and new oral diabetes medications, new drugs to help people who want to quit smoking and new antimicrobial drugs to treat serious bacterial and fungal infections.

The lists aim to address global health priorities, identify the drugs that provide the greatest benefit and that should be accessible and accessible to all. However, high prices for both new, patented drugs and older drugs, such as insulin, still keep some essential drugs unavailable to many patients.

“Diabetes is on a global rise and is growing faster in low- and middle-income countries,” said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General. “Too many people who need insulin run into financial difficulties in accessing, or without it, and lose their lives. The inclusion of insulin analogues in the list of essential medicines, together with efforts to ensure affordable access to all insulin products and to expand the use of biosimilars, is a vital step towards ensuring access for all who need this life-saving product. ”

Medicines for diabetes

Insulin was discovered as a cure for diabetes 100 years ago, and human insulin has been on the WHO list of essential medicines since it was first published in 1977. Unfortunately, limited insulin supplies and high prices in several low- and middle-income countries are currently a significant obstacle in treatment. For example, in Ghana’s capital, Accra, the amount of insulin needed in a month would cost a worker the equivalent Payment 5.5 days per month. Insulin production is concentrated in a small number of manufacturing plants, with three manufacturers controlling most of the world market, and a lack of competition resulting in high prices that are banned for many people and health systems.

The move to a list of long-acting insulin analogues (insulin degludec, detemir, and glargine) and their biosimilars, along with human insulin, is intended to increase access to diabetes treatment by expanding treatment choices. Inclusion on the list means that biologically similar insulin analogs may be eligible for the WHO prequalification program; WHO prequalification can result in the entry of more similar products of quality assurance into the international market, creating competition for lower prices and giving countries a wider choice of products.

Long-acting insulin analogues offer some additional clinical benefits to patients due to their prolonged action, which ensures that blood glucose levels can be controlled over a longer period of time without the need for an increased dose. They offer a special benefit for patients who have dangerously low blood glucose levels with human insulin. Greater flexibility in dosing and dosing of insulin analogs has been shown to improve the quality of life of patients with diabetes. However, human insulin remains the mainstay in the treatment of diabetes, and access to this life-saving drug must continue to be supported by better availability and affordability.

The list also includes sodium glucose co-transporter-2 (SGLT2) inhibitors empagliflozin, canagliflozin and dapagliflozin as second-line therapy in adults with type 2 diabetes. These orally administered drugs have been shown to offer several benefits, including a lower risk of death, failure renal and cardiovascular events. Since SGLT2 inhibitors are still patented and expensive, their inclusion in the list comes with a recommendation that the WHO cooperate with Patent set of drugs promote access through potential licensing agreements with patent holders to enable generic production and supply in low- and middle-income countries.

Improving access to diabetes drugs, including insulin and SGLT2 inhibitors, is one of the workflows of the Global Diabetes Agreement, launched by the WHO in April 2021, and is a key topic discussed with diabetes drug manufacturers and health technologies.

Cancer drugs

Crabs are among the leading causes of disease and death in the world, accounting for nearly 10 million deaths in 2020, seven out of 10 occurring in low- and middle-income countries. In recent years, new advances have been made in cancer treatment, such as drugs targeting specific molecular characteristics of tumors, some of which offer much better outcomes than “traditional” chemotherapy for many cancers. Four new cancer drugs have been added to the model list:

• Enzalutamide, as an alternative to abiraterone, for prostate cancer;
• Everolimus, for subependymal giant cell astrocyte (SEGA), a type of brain tumor in children;
• Ibrutinib, a targeted drug for chronic lymphocytic leukemia; and
• Rasburicase, for tumor lysis syndrome, is a serious complication of some cancer treatments.

The list of imatinib has been expanded to target the treatment of leukemia. New indications for childhood cancer have been added for the 16 drugs already listed, including low-grade glioma, the most common form of brain tumor in children.

A group of antibodies that enhance the immune response to tumor cells, called PD-1 / PD-L1 immune checkpoint inhibitors, is not recommended for use in the treatment of a number of lung cancers, despite being effective, mainly because of their extremely high cost and concern. difficult to manage in low-resource health systems. Other cancer drugs are not recommended for listing due to uncertain additional clinical benefits compared to the drugs already listed, high cost, and management problems in low-resource environments. These include Osimertinib for lung cancer, daratumumab for multiple myeloma, and three types of treatment (CDK4 / 6 inhibitors, fulvestrant, and pertuzumab) for breast cancer.

Another development

Infectious diseases – The new drugs include cefiderocol, an antibiotic from the “Reserve” group effective against multidrug-resistant bacteria, echinocandinic antifungals for severe fungal infections and monoclonal antibodies to prevent rabies – the first monoclonal antibodies against infectious diseases to be included in the model lists. Updated lists also see new drug formulations for common bacterial infections, hepatitis C, HIV, and tuberculosis, to better meet the dosing and administration needs of both children and adults. An additional 81 antibiotics were classified as an approach, surveillance, or reserve within the AWaRe framework, to support antimicrobial management and control of antibiotic use worldwide.

Smoking cessation -Two nicotine-based drugs — bupropion and varenicline — join nicotine replacement therapy on the model list, providing alternative treatment options to people who want to quit smoking. The ad aims to support the race to achieve WHO Commit to giving up‘The aim of the campaign is to quit smoking in the next year by 100 million people worldwide.

Note to editors

Meeting 23^rd An expert committee for the selection and use of essential medicines was held practically from June 21 to July 2. The expert committee considered 88 drug applications to be added 21^All List of WHO Essential Drug Models (EML) and 7^th List of WHO Essential Medicines for Children (EMLc) models. WHO technical departments were involved and consulted on applications related to their disease areas.

The updated List of Essential Medicines includes 20 new medicines for adults and 17 for children, and lists new uses for the 28 medicines already mentioned. The changes recommended by the Expert Committee increase the number of drugs considered essential to address key health needs to 479 at the EML and 350 at the EMLc. Although these numbers may seem high, they are only a small fraction of the total number of drugs available on the market.

Governments and institutions around the world continue to use the WHO Model List to guide the development of their own lists of essential medicines, knowing that each listed drug has been tested for efficacy and safety and provides value for money for the health outcomes they produce.

The list of models is updated every two years by an expert committee, composed of recognized experts from academia, the research and medical and pharmaceutical professions. This year, the Committee stressed the urgent need to take action to promote fair and affordable access to essential medicines through inventories and complementary measures, such as voluntary licensing mechanisms, joint procurement and price negotiations.