WHO today published the new edition of its Model Lists of Essential Medicines and

Essential Medicines for Children, which include new treatments for various cancers,
insulin analogues and new oral medicines for diabetes, new medicines to assist people
who want to stop smoking, and new antimicrobials to treat serious bacterial and fungal
infections. 

The listings aim to address global health priorities, identifying the medicines that provide
the greatest benefits, and which should be available and affordable for all. However,
high prices for both new, patented medicines and older medicines, like insulin, continue
to keep some essential medicines out of reach for many patients. 

“Diabetes is on the rise globally, and rising faster in low- and middle-income countries,”
said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Too many people who
need insulin encounter financial hardship in accessing it or go without it and lose their
lives. Including insulin analogues in the Essential Medicines List, coupled with efforts to
ensure affordable access to all insulin products and expand use of biosimilars, is a vital
step towards ensuring everyone who needs this life-saving product can access it.”

Medicines for diabetes

Insulin was discovered as a treatment for diabetes 100 years ago and human insulin
has been on WHO’s List of Essential Medicines since it was first published in 1977.
Unfortunately, limited insulin supply and high prices in several low- and middle-income
countries are currently a significant barrier to treatment. For example, in Ghana’s
capital, Accra, the amount of insulin needed for a month would cost a worker the
equivalent of 5.5 days of pay per month. Insulin production is concentrated in a small
number of manufacturing facilities, and three manufacturers control most of the global
market, with the lack of competition resulting in high prices that are prohibitive for many
people and health systems.

The move to list 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 the choice of treatment. Inclusion in the List means
that biosimilar insulin analogues can be eligible for WHO’s prequalification programme;
WHO prequalification can result in more quality-assured biosimilars entering the
international market, creating competition to bring prices down and giving countries a
greater choice of products. 
Long-acting insulin analogues offer some extra clinical benefits for patients through their
prolonged duration of action, which ensures that blood glucose levels can be controlled
over longer periods of time without needing a booster dose. They offer particular benefit
for patients who experience dangerously low blood glucose levels with human insulin.
The greater flexibility in timing and dosing of insulin analogues has been shown to
improve quality of life for patients living with diabetes. However, human insulin remains
a staple in the treatment of diabetes and access to this life-saving medicine must
continue to be supported through 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 medicines have been shown to offer several
benefits, including a lower risk of death, kidney failure and cardiovascular events.
Because SGLT2 inhibitors are still patented and high-priced, their inclusion in the list
comes with the recommendation that WHO work with the Medicines Patent Pool to
promote access through potential licencing agreements with the patent-holders to allow
generic manufacturing and supply in low- and middle-income countries. 

Improving access to diabetes medicines including insulin and SGLT2 inhibitors is one of
the workstreams of the Global Diabetes Compact, launched by WHO in April 2021, and
a key topic under discussion with manufacturers of diabetes medicines and health
technologies.

Cancer medicines

Cancers are among the leading causes of illness and death worldwide, accounting for
nearly 10 million deaths in 2020, with seven out of 10 occurring in low- and middle-
income countries. New breakthroughs have been made in cancer treatment in the last
years, such as medicines that target specific molecular characteristics of the tumour,
some of which offer much better outcomes than “traditional” chemotherapy for many
types of cancer. Four new medicines for cancer treatment were added to the Model
Lists:

 Enzalutamide, as an alternative to abiraterone, for prostate cancer;

 Everolimus, for subependymal giant cell astrocytoma (SEGA), a type of brain
tumour in children;
 Ibrutinib, a targeted medicine for chronic lymphocytic leukaemia; and
  Rasburicase, for tumour lysis syndrome, a serious complication of some cancer
treatments.

The listing for imatinib was extended to include targeted treatment of leukaemia. New
childhood cancer indications were added for 16 medicines already listed, including for
low-grade glioma, the most common form of brain tumour in children. 

A group of antibodies that enhance the immune response to tumour cells, called PD-1 /
PD-L1 immune-checkpoint inhibitors, were not recommended for listing for the
treatment of a number of lung cancers, despite being effective, mainly because of their
exceedingly high price and concerns that they are difficult to manage in low-resourced
health systems. Other cancer medicines were not recommended for listing due to
uncertain additional clinical benefit compared with already listed medicines, high price,
and management issues in low-resource settings. These included osimertinib for lung
cancer, daratumumab for multiple myeloma, and three types of treatment (CDK4/6
inhibitors, fulvestrant and pertuzumab) for breast cancer. 

Other developments

Infectious diseases - New medicines listed include cefiderocol, a ‘Reserve’ group

antibiotic effective against multi-drug resistant bacteria, echinocandin antifungals for
severe fungal infections and monoclonal antibodies for rabies prevention – the first
monoclonal antibodies against an infectious disease to be included on the Model Lists.
The updated lists also see new formulations of medicines for common bacterial
infections, hepatitis C, HIV and tuberculosis, to better meet dosing and administration
needs of both children and adults. An additional 81 antibiotics were classified as
Access, Watch or Reserve under the AWaRe framework, to support antimicrobial
stewardship and surveillance of antibiotic use worldwide.

Smoking cessation – Two non-nicotine-based medicines – bupropion and varenicline

– join nicotine-replacement therapy on the Model List, providing alternative treatment
options for people who want to stop smoking. Listing aims to support the race to reach
WHO’s ‘ Commit to Quit’ campaign goal that would see 100 million people worldwide
quitting smoking over the coming year.

Note to Editors
The meeting of the 23rd Expert Committee on the Selection and Use of Essential
Medicines was held virtually from 21 June to 2 July. The Expert Committee considered
88 applications for medicines to be added to the 21 st WHO Model List of Essential
Medicines (EML) and the 7th WHO Model List of Essential Medicines for Children
(EMLc). WHO technical departments were involved and consulted with regard to
applications relating to their disease areas.

The updated Essential Medicines Lists include 20 new medicines for adults and 17 for
children and specify new uses for 28 already-listed medicines. The changes
recommended by the Expert Committee bring the number of medicines deemed
essential to address key public health needs to 479 on the EML and 350 on the EMLc.
While these numbers may seem high, they are only a small proportion of the total
number of medicines available on the market.

Governments and institutions around the world continue to use the WHO Model Lists to
guide the development of their own essential medicines lists, because they know that
every medicine listed has been vetted for efficacy and safety and delivers value for
money for the health outcomes they produce. 

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. This year, the Committee underscored the urgent need to take action to
promote equitable and affordable access to essential medicines through the list and
complementary measures such as voluntary licensing mechanisms, pooled
procurement, and price negotiation.