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Bottles of genetically engineered human insulin at an inspection line at the Russian company GEROPHARM. Anton Novoderezhkin\TASS via Getty Images
  • The World Health Organization (WHO) recently released a report highlighting the disturbing inequities in global access to insulin, related devices, and diabetes care.
  • Some barriers to access include high prices, inadequate availability of human insulin, a limited number of manufacturers, and suboptimal health systems.
  • The report identifies five strategies to address access gaps and inequalities in order to improve the health of people with diabetes requiring insulin worldwide.

Insulin is a hormone that the pancreas produces. It is necessary for the body to utilize or store the blood sugar from the food we eat.

Diabetes occurs when either the pancreas does not produce enough insulin or cells do not respond to the insulin in the body.

Chronically high blood glucose levels due to diabetes may result in long-term complications, such as vision loss, kidney failure, lower limb amputation, heart attack, and strokes. Currently, more than 420 million people worldwide live with diabetes.

According to the report, globally, about 9 million people with type 1 diabetes rely on insulin for survival, and about 63 million individuals with type 2 diabetes require insulin for treatment.

Although the discovery of insulin in 1921 revolutionized diabetes treatment, inadequate access to insulin and diabetes care in many countries remains a century later.

Considerable access gaps exist, especially in low and middle income countries, despite the increasing burden of diabetes. An estimated 80% of people with diabetes globally live in low and middle income countries.

The recent WHO report describes the current barriers to insulin access, identifies the causes of these barriers, and suggests strategies to improve access to affordable, safe, and effective insulin and devices globally.

Currently, insulin is not affordable or available in many countries. The WHO explained to Medical News Today in an interview that one cause of “unaffordable pricing […] is a market shift from lower-priced human insulin to higher-priced insulin analogues.”

Dr. Kasia Lipska is an associate professor of medicine at the Yale School of Medicine in New Haven, CT. In 2018, she spoke at a panel discussion called “Drug prices in the spotlight: Why are insulin costs rising, and what can be done?”

In it, she explained: “About 15 years ago, a vial of insulin called Humalog cost about $59 per vial. Now, in 2018, that same vial, same insulin […], same product costs around $300.”

She added: “That’s happened across lots of different types of insulin, and particularly the […] insulin analogues — the ones that were developed in the 2000s. They’ve increased in price dramatically and exponentially over the past decade or so.”

In an MNT interview, Dr. Ruth Weinstock, Ph.D., president of Medicine & Science for the American Diabetes Association, stated:

“This has caused many individuals to ration their insulin or not take insulin, causing life threatening acute and chronic complications and even death. In the United States, this is a major problem for individuals who do not have health insurance, as well as for those with healthcare coverage that has high copays or high deductibles.”

In an outpatient survey at the Yale Diabetes Center, 25% of patients with type 1 or type 2 diabetes reported using less insulin due to insulin costs. Three pharmaceutical companies monopolize insulin supply worldwide, promoting noncompetitive pricing, supply, and demand.

These practices discourage the development of biosimilar products, effectively suppressing the competition.

Dr. Weinstock commented: “Devices and supplies used to monitor glucose levels and help direct and adjust
dosing so that insulin is administered safely are also expensive. When glucose is not monitored, insulin therapy cannot be optimized, and both hypoglycemia and serious hyperglycemia can be undetected.”

The WHO told MNT, “The market is characterized by market exclusivity due to patents, excessive product differentiations, and problematic marketing practices.” Manufacturers lock consumers into using high-cost brand-name glucose strips by providing free or low-cost glucose meters. They refer to this as “freemium marketing practice.”

Dr. Weinstock added: “In low and middle income countries, the high cost of insulin, as well as supply and distribution costs, can be prohibitive. There also can be a lack of adequate refrigeration, so insulin cannot be stored properly, causing loss of potency in hot weather.”

According to the WHO: “In many countries, insulin and diabetes care are only available at secondary or tertiary hospitals at a level insufficient to meet the need. Knowledge and competencies of healthcare workers in using insulins and educating patients may not be available.”

The WHO report outlines a five-step action plan to improve insulin and associated devices access. The first step involves improving the accessibility of human insulin and insulin analogues, particularly biosimilar insulin, by keeping human insulin on the market and improving availability.

Dr. Weinstock explained to MNT: “The WHO recommends maintaining and expanding the sale and use of the less expensive human insulins in resource-poor areas. […] It is hoped that increased availability of high-quality interchangeable biosimilar insulins will lead to more availability and reduction in cost as well.”

Secondly, WHO recommends improving the affordability of insulin by:

  • including a variety of insulins in the national essential medication list
  • enacting policies promoting market transparency with regard to patents, supply arrangements, and pricing
  • developing affordable purchasing and pricing policies to ensure lower out-of-pocket costs

The third step outlines addressing problems with access to devices and services by including devices for administration of insulin, glucose monitoring, and related diabetes management services in health benefits packages. Other recommended measures include eliminating “freemium” marketing and reforming patent practices.

The fourth area for action involves building capability and infrastructure investment to support insulin access. Dr. Weinstock elaborated:

“The WHO also recommends […] the building of infrastructure to increase the capacity to manufacture and distribute insulin locally, and increasing research, development, and collaborations between countries related to the production and distribution of insulin and the training of healthcare workers in primary care.”

The fifth step, according to the WHO, to improve the availability of insulin and related devices involves supporting research and development through the improved collection, analysis, and publication of data related to pricing and usage.

Dr. Weinstock told MNT, “Research is needed for the development of insulins that are more temperature stable and therefore more accessible for low and middle income countries where a lack of electricity is a major barrier.”

She summarized: “Changes in pricing policies, insurance reimbursement policies, and related regulations are needed to keep insulin, insulin delivery devices, and supplies and glucose monitoring supplies and devices affordable to prevent premature morbidity and mortality. Access to healthcare professionals knowledgeable about diabetes and insulin therapy is also needed to improve the health of all people with insulin-requiring diabetes.”