By Sharon Atieno

Though the number of people with diabetes worldwide is expected to reach 643 million by 2030, and 700 million by 2045 – rising mostly in low-and-middle-income countries (LMICs), access to insulin remains limited.

This is according to a new report by the Access to Medicine Foundation which found that the three pharmaceutical manufacturers which dominate the insulin market (at 90%) do not make all their products available in every country in the world.

Further, many people living in LMICs have access only to a limited selection of insulin products, while in others there are no options to choose from whatsoever. “In these countries, which are among some of the poorest in the world, none of these companies’ products are made available – meaning that diabetics simply cannot get the insulin they need,” the report notes.

Though registering a medicine is a necessary step that enables its sale in a country, based on analysis of the data available, only 29 of the 108 countries in scope have all the insulins (analogue and human) classified as “essential medicines” by World Health Organization (WHO) registered, and only one of those is a low-income country. Worse, in 24 countries, no insulins were found to be registered at all.

“This means that people living in these countries have no access to insulin – and the stark reality is that without access to insulin, many more diabetic children and adults will suffer and die from this life-long, chronic disease,” the report notes.

Notably, affordability has been found to be a key barrier to insulin access in most LMICs. While the public sector covers the cost of insulin in some of these countries, either directly or via reimbursement, many patients in LMICs pay out-of-pocket.

Additionally, many people still struggle to access human insulin, as it is not always available and is often unaffordable, especially in low-resource settings. Access to insulin analogues is even more limited. “Even when these products are available, they are often unaffordable. Prices are two to six times higher than those of human insulins, with affordability varying significantly between countries,” the report says.

In terms of controlling blood glucose levels, analogue insulins provide equal effectiveness in comparison to human insulins, while having the potential to decrease adverse effects. Analogues can also be administered more conveniently and increase patients’ adherence to treatment.

Despite this, most people living in LMICs, the report notes do not have access to analogues or more convenient delivery methods. Analogues are still not listed on many LMICs’ National Essential Medicines Lists, and consequently not supplied in the public sector, as is the case in countries including Senegal and Myanmar. Even where they are listed on a country’s National Essential Medicines List, this does not always mean that patients have access to such products via the public sector, as is the case in Kenya.

The report observes that the main insulin manufacturers – Eli Lilly, Novo Nordisk and Sanofi -are pursuing different strategies to expand access to their products in LMICs, including paediatric programmmes, price ceilings, and equitable pricing policies.

However, there are persistent gaps in access to all insulins; most affordability strategies remain primarily focused on human insulins and few are found for analogue products.

“Less than 30% of low- and middle-income countries currently have access to all insulins deemed essential, with the cost of insulin being a huge barrier to access. Insulin products, particularly analogue insulins, need to become affordable to every payer,” Claudia Martínez, Research Programme Manager, Access to Medicine Foundation.

“Tapping into the promising potential of biosimilar insulins, for example, could expand affordability and access. While access to insulin is a complex, multifaceted issue, more efforts are needed on a greater scale, covering a wider range of products.”

Biosimilar drugs are copies of a biopharmaceutical product; but because of the inherent nature of biological products, the process is more complex and while they are produced in the same way and can have a similar clinical effect, exact replicas cannot be obtained.

According to the report, the introduction of biosimilar insulins in LMICs has the potential to lower prices for governments and patients.

Also, the report recommends that companies pursue long-term financial sustainability to ensure affordable insulins are available to people in LMICs through further collaborations with governments and partners to integrate more access programmes into local health systems, alongside company affordability strategies and initiatives, particularly for analogue insulins.

“While diabetes care has advanced since the discovery of insulin 100 years ago, this highly effective drug, and the range of products that help manage chronic diabetes, is only available to a fortunate few… This report highlights the urgent actions companies, governments and their partners can take to provide patients in resource-limited settings with the choice of treatment they deserve – no matter where they live,” Jayasree K. Iyer, CEO, Access to Medicine Foundation.