New WHO report: A call to action to increase the availability of low-cost insulin

Bottles of genetically engineered human insulin at an inspection line at the Russian company GEROPHARM.
Anton NovoderezhkinTASS via Getty Images
Bottles of genetically engineered human insulin at an inspection line at the Russian company GEROPHARM.
Anton NovoderezhkinTASS via Getty Images
  • The World Health Organization (WHO) has published a study outlining alarming disparities in global access to insulin, associated devices, and diabetes treatment.
  • High prices, a lack of human insulin, a small number of manufacturers, and ineffective health systems are some of the hurdles to access.
  • In order to enhance the health of people with diabetes who use insulin throughout the world, the study suggests five ways to address access gaps and inequities.

Insulin is a hormone produced by the pancreas. The body need blood sugar from the food we eat to be used or stored.

Diabetes develops when the pancreas does not create enough insulin or when the body’s cells do not respond to insulin.

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. Diabetes can cause long-term problems such as eyesight loss, renal failure, lower limb amputation, heart attacks, and strokes. Diabetes affects more than 420 million people throughout the world.

According to the research, around 9 million people with type 1 diabetes require insulin to survive, and approximately 63 million people with type 2 diabetes require insulin to be treated.

Despite the fact that the discovery of insulin in 1921 changed diabetes therapy, many nations still lack proper access to insulin and diabetes care a century later.

Despite the rising prevalence of diabetes, significant access gaps continue, particularly in low- and middle-income nations. Throughout 80% of people with diabetes reside in low- and middle-income nations around the world.

The present limitations to insulin availability are described in a recent WHO study, which also analyzes the reasons of these constraints and offers ways to enhance worldwide access to inexpensive, safe, and effective insulin and devices.

Causes and obstacles

Insulin is now unavailable or unaffordable in many nations. One source of “unaffordable pricing […] is a market shift from lower-priced human insulin to higher-priced insulin analogues,” according to the WHO in an interview with Medical News Today.

Dr. Kasia Lipska is a medical associate professor at Yale School of Medicine in New Haven, Connecticut. She presented at a panel discussion titled “Drug prices in the spotlight: Why are insulin costs rising, and what can be done?” in 2018.

“About 15 years ago, a vial of insulin called Humalog cost about $59 per vial,” she said. That same vial, same insulin […], same product now costs roughly $300 in 2018.”

“That’s happened across many different forms of insulin, notably the […] insulin analogues – the ones produced in the 2000s,” she continued. Over the last decade or two, their price has risen substantially and enormously.”

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

“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 study conducted by the Yale Diabetes Center, 25% of patients with type 1 or type 2 diabetes said they used less insulin because of the high cost of insulin. Insulin is monopolized by three pharmaceutical corporations across the world, resulting in noncompetitive price, supply, and demand.

These actions stifle the development of biosimilars, thus suffocating competition.

Dr. Weinstock commented: “Devices and supplies used to monitor glucose levels and help direct and adjust

Dosing to ensure that insulin is delivered safely is likewise costly. Insulin therapy cannot be optimized without glucose monitoring, and hypoglycemia and significant hyperglycemia might go unnoticed.”

“Market exclusivity is characterized by patents, excessive product differentiations, and questionable marketing methods,” the WHO told MNT. By giving free or low-cost glucose meters, manufacturers entice consumers to use high-cost brand-name glucose strips. This is referred to as “freemium marketing technique” by them.

“In low- and middle-income nations, the high cost of insulin, as well as supply and distribution expenses, might be prohibitive,” Dr. Weinstock continued. Insulin may also be unable to be kept effectively due to a lack of appropriate refrigeration, resulting in potency loss in hot conditions.”

“In many countries, insulin and diabetes care is only accessible in secondary or tertiary hospitals at a level that is insufficient to satisfy the requirement,” according to the WHO. It’s possible that healthcare providers’ knowledge and skills in utilizing insulins and teaching patients aren’t available.”

Plan of Action

The WHO study lays out a five-step plan to enhance access to insulin and related devices. The first step is to make human insulin and insulin analogues, especially biosimilar insulin, more accessible by maintaining human insulin on the market and increasing availability.

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

Second, WHO suggests that insulin be made more affordable 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 discusses how to address issues with device and service access by adding insulin delivery devices, glucose monitoring devices, and related diabetes management services in health coverage packages. Eliminating “freemium” marketing and changing patent processes are also proposed.

Building capability and infrastructure investment to facilitate insulin access is the fourth area for action. Dr. Weinstock went on to say:

“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.”

According to the WHO, the fifth stage in improving the availability of insulin and associated devices is to promote research and development by improving the collection, analysis, and dissemination of data on cost and usage.

“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.”” Dr. Weinstock told MNT.

“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. she concluded.