New WHO Essential Medicines List Includes Controversial Insulin Analogues; Recommends Action on High Medicines Prices  
insulin, an essential medicine
Insulin, a lifesaving treatment for those with diabetes, remains difficult to access and afford in low- and middle-income countries

The World Health Organization published the latest edition of its Model Lists of Essential Medicines (EML) on Friday, making a sweeping move this time to include long-lasting insulin analogues as essential drugs that national health systems should incorporate into their services. 

The decision reverses the EML Expert Committee’s 2019 decision, rejecting the inclusion of insulin analogues – on the basis that these higher-priced formulations could negatively affect access to lower-cost human insulin products. 

The EML, first developed by WHO in 1977 and updated every two years in consultation with experts worldwide, provides a baseline of guidance to national health authorities on the products and services that should be made most widely available. 

Although the prevalence of diabetes has nearly doubled over the past 30 years, rising faster in low- and middle-income countries, high prices have kept many from accessing essential treatments, traditionally involving human insulin, produced by only three firms worldwide. 

This led industry as well as some access advocates to propose WHO’s incorporation of newer “insulin analogues” an altered form of human insulin that can be used to treat Type 1 diabetes, to drive competition and lower prices.  The proposals drew controversy even prior to their rejection in 2019.

Scientific experts, civil society, and patient groups had met the proposal to include analogues in 2019 with stiff resistance, fearing that mainstreaming the newer drugs, which are more expensive, into the EML, could ultimately drive up prices for developing countries

But two years later, the use of analogues has expanded much more, while prices have decreased, with treatments no longer under patent protection in many countries. In settings where cost containment and efficient negotiations with insulin producers are in place, prices for insulin analogues are decreasing and aligning with those of human insulin.

This year’s EML decision reverses the 2019 recommendation 

That laid the groundwork for the EML expert committee to reverse their position in this year’s edition of the EML, which is issued every biennium, for almost exactly the same reason – to make insulin more affordable by promoting more insulin alternatives. 

WHO Director-General Dr Tedros Adhanom Ghebreyesus noted that the inclusion of insulin analogues is a ‘step’ in the right direction towards ensuring affordable access to a  lifesaving treatment that only about 50% of an estimated 100 million people requiring insulin, are able to receive, according to a 2017 study led by Health Action International

“Too many people who need insulin encounter financial hardship in accessing it or go without it and lose their lives,” said Tedros. “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.”

Prior rejection of analogues due to high price concerns 

Echoing Tedros’ statement, the EML committee stressed that further price containment measures still need to be pursued to make insulin of all types more widely available: 

The Committee noted the ongoing concerns of some access groups on the effects of including insulin analogues into the EML, stating: 

“[The similar clinical benefits of long-acting insulin analogues and human insulin] make the large price differential between insulin analogues and human insulin difficult to justify…“The Committee was unequivocal that affordable access to human insulin remains a critical priority, globally.”

Another First – EML thrusts high drug prices to forefront of essential medicines debate 

The Committee’s inclusion of long-acting insulin analogues also comes with another unprecedented move – the recommendation of establishing a standing EML Working Group on highly-priced essential medicines, fulfilling long-standing aspirations of medicine advocacy groups that wanted prices to be highlighted more in the EML. 

“[The EML] has never been so explicit about pricing,” said Thiru Balasubramaniam, Geneva Representative for Knowledge Ecology International (KEI), in an interview with Health Policy Watch

“They usually just list medicines and then talk about the reasons for inclusion for each one, but I can’t remember a time when there was a section that basically highlighted the effect of highly-priced medicines.”   

One of the tasks of the Working Group is to be: “the development of a strategy to monitor price and availability trends of essential but unaffordable medicines, to be proposed as part of the next WHO General Programme of Work.” 

For over a decade, advocacy groups such as Knowledge Ecology International (KEI), have pushed the EML to include a section on essential, but unaffordable medicines, making this new recommendation from the Committee a strategic success.   

“[KEI] has asked several times to create a category in the EML, of products that would be essential, if affordable. Now, as someone who has worked on this for over a decade, this is it,” Balasubramaniam said.

KEI had recently advocated for the new category back in June, during the two-week meeting of the Committee.  

Prioritizing cancer treatments and new indicators for cancer 

Cancer medicines were also a priority for this updated EML

In addition to including insulin analogues, the Committee also recommended 20 new medicines to the EML and 17 new medicines for the Essential Medicines List for Children (EMLc), prioritizing treatment for various cancers. 

Four new medicines for cancer treatment were added to the EML:

–    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.

Enzalutamide, also known as Xtandi, was part of a lawsuit from the University of California against generic production in India in 2019

UCLA, which originally developed the treatment in 2006, later sold and licensed rights to manufacture and market the drug to for-profit pharmaceutical firms, with those rights eventually acquired by the US-based Pfizer and the Japanese-based Astrellas.

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

The updated list also has new formulations of medicines for common bacterial infections, hepatitis C, HIV, and tuberculosis, to meet dosing and administration needs of both children and adults. 

Médecins Sans Frontières calls for even more action from WHO and pharma companies on insulin access 

While Médecins Sans Frontières/Doctors Without Borders (MSF) welcomed the addition of more insulin products to the EML, the group urged WHO and insulin companies to take an even stronger stance on ensuring access to these medicines. 

“We hope that the WHO and companies manufacturing insulin will waste no time in ensuring the availability of more affordable quality assured biosimilar insulins to meet people’s growing need for this life saving medicine,” said Candice Sehome, Advocacy Officer in the MSF Access Campaign. 

“It is preposterous that this medicine discovered 100 years ago still remains inaccessible to half of the people who need it.”

“Unless the price of all types of insulin and the medical supplies required to inject and monitor this treatment comes down, governments will continue to struggle to manage this controllable disease and people with diabetes will keep dying.”

Image Credits: WHO, WHO.

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