Half the People Living with Diabetes Can’t Afford Insulin, WHO Report Shows Medicines & Vaccines 13/11/2021 • Aishwarya Tendolkar Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Checking blood sugar levels in Kenya for control of diabetes. The inflated costs of insulin and control of its price and supply – are barriers preventing people with diabetes from accessing this life-saving medicine, according to a report released by the World Health Organization (WHO). Insulin is the basis of diabetes treatment, essential for nine million people with type 1 diabetes who cannot make the hormone that controls the blood glucose level, and 63 million people living with type 2 diabetes, with limited or diminishing insulin. It reduces the risk of kidney failure, blindness and limb amputation – but half the people living with type-2 diabetes cannot afford it. Around 90% of the market tightly controlled by three multinational companies: Novo Nordisk, Eli Lilly, and Sanofi, according to the WHO report. With a higher number of people today being diagnosed with diabetes, the WHO has said that unaffordable insulin, stakes of multi-billion dollar companies in manufacturing and supply, and storage of the life-saving medicine are the main barriers of access to insulin. According to the report, released to coincide with World Diabetes Day on 14 November, the use of insulin analogues, or synthetic insulin, has increased in high-and middle-income countries although it is significantly more expensive than human insulin. Eighty percent of the 420 million people living with diabetes live in low- and middle-income countries.Type-2 diabetes is the most common type of diabetes and access to affordable insulin and treatment is critical to their survival. The 🆕 WHO report on global access to #insulin shows how a century after its discovery, insulin remains inaccessible or unaffordable for many children and adults living with #diabetes around the 🌍🌎🌏. More here 👉https://t.co/kcaqh6tYO1 — World Health Organization (WHO) (@WHO) November 12, 2021 There is a globally agreed target to halt the rise in diabetes and obesity by 2025. Currently, over a million deaths each year are directly attributed to diabetes. Lower-income countries bear the brunt Insulin was discovered a century ago and the scientists then had sold its patent for a dollar to encourage its use for saving lives and not to make profits. “Unfortunately, that gesture of solidarity has been overtaken by a multi-billion-dollar business that has created vast access gaps. WHO is working with countries and manufacturers to close these gaps and expand access to this life-saving medicine for everyone who needs it,” said WHO Director-General, Dr Tedros Adhanom Ghebreyesus. According to an article in the latest edition of The Lancet, 25% of the seven million insulin patients in the United States, a high-income country, struggle with its high cost. Controversial insulin pricing practices, including price-fixing, has led to repeated market failures and continued unnecessary deaths in the U.S, the Lancet article showed. The pricing landscape is also uneven and reveals a lack of transparency in the way prices are set, according to the report. The benefits of cheaper biosimilar insulins are not enjoyed by many countries, including lower-income ones. Although three-quarters of type-2 diabetics live outside North America and Europe, yet these two regions accounted for 60% of revenue worth US$16.6 billion in 2020. The report highlights that there are a “significant number of underserved markets” in lower-income countries and in the WHO African Region, WHO South-East Asia Region and WHO Eastern Mediterranean Region. The market for insulin and diabetic care has shifted from human insulin, which can be produced at relatively low cost, to more expensive analogues or synthetic insulins, which are up to three times the cost. This has financially burdened lower-income countries. One of the studies cited in the report showed that the lowest-paid unskilled government workers in the 13 low-and middle-income countries studied would need to spend six to eight days of wages to purchase 1000 IU insulin analogue doses in the public sector and 7–16 days’ wages to purchase the same in the private sector. To buy human insulin would need four days’ of wages n the public sector and two-four days in the private sector. Expensive insulin is not the only problem The report also highlighted the issue of access to devices and equipment for monitoring glucose levels. These are necessary for the detection of the disease and its complications and are responsible for shaping insulin use and diabetes care. In low-, middle-and upper middle-income countries, less than 50 percent of primary health care facilities have the needed supplies for measuring glucose and the apparatus for screening diabetes complications. Half to one-third of these tested devices were able to meet the standards of International Organization for Standardisation (ISO). All forms of human insulin are no longer under patent protection. There is a lack of biosimilar human insulin approved by stringent regulatory authorities. Currently, intellectual property barriers created by patents on devices and secondary patents have implications on pricing and affordability, the report said. So what is the solution? WHO recommends the increased local production of insulin and associated devices to cater to the demands of the population without having to pay a premium to large conglomerates. Locally produced quality-assured insulins and associated devices may also improve to scale up production and operational costs. Currently, case studies in six low-and middle-income countries showed that there was a cumulative mark-up of 8.7% to 565.8% for insulin, depending on country and health system context. The WHO report also highlights the need to improve the collection and publication of data on diagnostic, pricing and usage of insulins and associated devices. Pharma response – high prices and access barriers are due to a wider range of supply chain factors In a response to the WHO report, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) took issue with the WHO claim that market dominance by the three largest insulin producers is the root cause of high prices in many low-and middle-income countries. The IFPMA cited a recent report by the IQVIA Institute, a pharma research firm, which surveyed 32 low- and middle-income countries finding “no correlation between the three largest companies’ market shares” and the average cost of insulin per day, adding that “other factors are evidently driving average costs per day for patients.” The report also notes that six large global biosimilar manufacturers and 12 other manufacturers are operating in the countries surveyed. “By way of example, one innovative biopharma company, Novo Nordisk, has committed to supplying human insulin in 76 LMICs at a cost of $2-3/vial – which equates to 8 or 12 cents per day for LMIC country purchasers that are governments or UN/humanitarian organizations, respectively, said the IFPMA statement. “And yet LMIC patients are still not getting access to insulin (or quality diabetes care) at the point of care. The reasons for this are complex and multi-faceted and do not fit a single narrative…. We recommend that all stakeholders acknowledge this reality, ‘roll up our sleeves’ and tackle it in a constructive, collaborative way while toning down the rhetoric. “From an LMIC patient perspective, organizations like PATH have highlighted the serious problems caused by massive pricing markups along the supply chain, which impact patients at the point of care. We also recommend a greater focus on the essential devices required to measure a patient’s blood glucose and to administer insulin safely and effectively. These elements go hand in hand with supporting patients with quality diabetes care, and (according to PATH and other organizations) often represent by far the greatest out-of-pocket cost for PLWDs. Concluded the IFPMA: “The pricing landscape is also uneven and reveals a lack of transparency in the way prices are set, according to the report. For example, biosimilar insulins (essentially generic versions) could be more than 25% cheaper than the originator product, but many countries, including lower-income ones, are not benefitting from this potential saving,” it stated, referring again to Novo Nordisk’s public commitment to sell insulin at $3/vial and $2/vial to UN/humanitarian organizations. It called for more “innovative approaches and multi-stakeholder partnerships to address the various barriers to access…. which are often overlooked and poorly understood. “These barriers include availability and pricing issues, to ensure there are appropriate, affordable products (insulin, other medicines, devices, diagnostics) at the point of care but go far beyond this. They include, for example, regulatory approval and policy issues; supply chain issues including cold chain; inventory management and aggregation of products; and other holistic issues such as lack of capacity in health systems, poor health literacy and empowerment of PLWDs, and inadequate financing.” Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.