E-DRUG: WHO prioritizes access to diabetes and cancer treatments in new Essential Medicines Lists
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Executive summary
<https://apps.who.int/iris/bitstream/handle/10665/345554/WHO-MHP-HPS-EML-2021.01-eng.pdf>
World Health Organization model list of essential medicines: 22nd list
<https://apps.who.int/iris/bitstream/handle/10665/345533/WHO-MHP-HPS-EML-2021.02-eng.pdf>
World Health Organization model list of essential medicines for children:
8th list
<https://apps.who.int/iris/bitstream/handle/10665/345534/WHO-MHP-HPS-EML-2021.03-eng.pdf
WHO prioritizes access to diabetes and cancer treatments in new Essential
Medicines Lists
High prices and low availability still a major barrier for
patients' access to new and old medicines
1 October 2021
News release
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
<https://www.who.int/news/item/13-11-2019-who-launches-first-ever-insulin-prequalification-programme-to-expand-access-to-life-saving-treatment-for-diabetes>\.
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
<https://medicinespatentpool.org/>
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 21st 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.
Bruneton Carinne
E-MED@healthnet.org
<carinne.bruneton@gmail.com>