The Cost of Living (with Diabetes)

A century after its discovery, insulin’s price tag in the U.S. remains alarmingly high for many people living with diabetes. While experts in healthcare and industry have worked with legislators to address the problem, much more needs to be done so that this lifesaving therapy is available to all who need it.

When Leonard Thompson’s life was saved by insulin 100 years ago, it changed the world. If diabetes had been the Gordian knot, insulin was and remains the best attempt at forging the blade to cut it. But right out the gate, there were problems. Banting and Best experimented on dogs, so locals began to claim that the scientists were stealing dogs, which led to some protest. Then there were tensions among the physicians over patents. The first American patient to receive insulin was Elizabeth Hughes, daughter of Secretary of State Charles Evans Hughes. According to Christopher Ruddy, PhD, a professional and public health historian and adjunct professor at the Dalla Lana School of Public Health at the University of Toronto, the key reason Banting accepted Elizabeth as a patient was that she had a private nurse, Blanche Burgess, who had valuable clinical experience.

In the early 1920s, the average person with diabetes had to spend about half their income on insulin. In 100 years, in the U.S. at least, not much has changed. There are many patients who ration their insulin because of cost, who have to decide whether to buy insulin or pay their rent, buy insulin or put food on the table, skimp on their livelihoods to save their lives. After 100 years, after Banting famously refused to put his name on the patent and Collip and Best sold the patent for $1, there are places in the world that can’t get access to insulin — a life-saving drug that’s been around for a century — at all.

“The paradox is that it’s partially the cost of insulin that’s preventing the people who need it, to actually get it,” says Robert Vigersky, MD, chief medical officer at Medtronic, director emeritus of Diabetes Institute at Walter Reed National Military Medical Center in Bethesda, Md., and past-president of the Endocrine Society. “And it’s really heartbreaking to see in low- and middle-income countries where the cost of insulin is prohibitive and/or the supply is just not there. The flip side is that in the developed countries in the world, there’s this huge disparity between cost of insulin in the U.S. versus Canada or Europe. And I think it just highlights that our system needs to be fixed and to make it equitable so that life-threatening conditions, which require a drug like insulin is available without an economic penalty associated with it.”

Make no mistake: Physicians, industry leaders, and lawmakers know that there’s a problem that needs to be addressed, and to their credit, they’ve taken some steps to lower costs. Pharmaceutical companies have introduced alternatives like biosimilars that should encourage competition and drive prices down, and legislation has been floating around to lower prescription drug prices across the board.

But for many people living with diabetes or taking care of someone with diabetes, those steps need to pick up the pace. “Insulin is a necessity for people with type 1 diabetes, and for many people with type 2 diabetes,” says Rita Kalyani, MD, associate professor and clinical researcher in the Division of Endocrinology, Diabetes, and Metabolism at Johns Hopkins School of Medicine in Baltimore. “Cost should not be a barrier to offering the standard of care treatment for any patient. Unfortunately, many patients who can’t afford insulin are being forced to ration their insulin or skip doses altogether until they can afford to pay for their insulin; this clearly impedes optimal diabetes care.”

And after 100 years, there are still those out there who could make a difference who seem to be doing their level best to dull the proverbial blade to cut that knot. “It’s an unintended consequence of our political system,” Vigersky says. “At the moment, there’s a lack of agreement on almost everything.”

But even with all the concern and public scrutiny surrounding insulin costs, not much is known about recent trends in its ambulatory use in the U.S., trends that could give insights into what drives insulin costs and potentially inform health policy.

Analog Impact

In October, JAMA Network Open published a paper titled “Trends in Insulin Types and Devices Used by Adults With Type 2 Diabetes in the United States, 2016 to 2020,” by Sudipa Sarkar, MD, MSC, et al, which noted that many have speculated that the trend in increasing insulin costs is due to increasing use of analog insulin, but that little is known about the recent trends in insulin use in the U.S.

“There has been increasing use of newer, analog insulins which predominate in the U.S. and have represented more than 80% of total insulin treatment visits over the past five years,” says Kalyani, the senior author of the paper. “The rising cost of analog insulins has far outpaced the rate of inflation. We need greater transparency to better understand the key drivers of insulin pricing; the continued introduction of biosimilars can also help create competition in the marketplace and help limit future price increases.”

The authors conclude that ambulatory insulin use in the U.S. during the past five years remained dominated using insulin analogs and insulin pen delivery devices, with increasing uptake of newer products as they have been brought to market. Insulin glargine represented more than half the insulin visits throughout the study period.

“Though clinical inertia may be a factor, on the other hand, we saw continued uptake of newer insulin products as they were brought to market including the use of biosimilar insulins,” Kalyani says. “Our study also did not investigate which specific insulins, for instance, were included on drug formularies.”

The authors also point out that for patients who can take human insulin, prescribing that could potentially offset the cost of newer insulins for patients who need them, which again speaks to tailored care. Kalyani says that she tries to explore lower-cost alternatives or patient assistance plans to help cover costs for insulin treatment in her practice.  “Patient-centered, individualized care is a core component in diabetes management,” Kalyani says. “The cost of insulin needs to be a factor in shared decision making with patients; for some patients, human insulin may be the better option and is also more affordable.”

In their conclusion, the authors write that an in-depth understanding of these recent trends in insulin use may shed light on what’s driving the increasing cost of insulin, as well as knowledge gaps that persist. “Understanding recent trends in the types of insulin that are most commonly used in the U.S. can provide important insights regarding the potential drivers of insulin cost,” Kalyani says. “Other knowledge gaps regarding the clinical use of insulin include a better understanding of the factors that influence the specific insulin product that providers recommend to their patients, or that patients prefer to use when managing their diabetes.”

A Call to Action and Advocacy

Last year, a paper appeared in the Mayo Clinic Proceedings that detailed the account of a patient with type 1 diabetes in his mid-20s who worked as a restaurant manager in Minnesota. He couldn’t afford the deductible and monthly premiums of his insurance, and he couldn’t afford to pay for his insulin with cash, so he tried to ration his insulin. He was found dead in his apartment from diabetic ketoacidosis.

The paper, “The High Cost of Insulin in the United States: An Urgent Call to Action,” by S. Vincent Rajkumar, MD, claims that the most common forms of analog insulin cost 10 times more in the U.S. than in any other developed country and points to the fact that some Americans are traveling to Canada and Mexico to purchase more affordable insulin.

And again, experts are painfully aware of scenarios like these. The Endocrine Society in January published a Position Statement that maps out some seemingly simple steps to increase insulin affordability, and the Society’s Advocacy team has laid out some policy options Congress could take and launched a campaign to encourage members to call on Congress to pass legislation to lower the cost of insulin. But simple doesn’t always mean easy.

Vigersky tells Endocrine News that from a policy standpoint, the biggest impact on the industry would come from Medicare allowing open bidding on insulin and be able to purchase insulin from international suppliers, which would set the standard for the rest of the players, whether that’s Medicaid or commercial payers. But he says that would take major legislation, which would affect the entire pharmaceutical industry, which is why such legislation has not been accepted.

For Vigersky, it’s going to take hitting the pavement to get something done. He points to Canada and Medicaid in Minnesota where they’re requiring Admelog to be used in people with type 1 diabetes and anyone else who requires rapid-acting insulin. “That’s additional pressure,” he says. “That’s essentially health ministry and major payer pressure that’s occurring to get the price down.”

“I think we want to, as individuals, as well as the [Endocrine] Society, advocate to our representatives in Congress and the Administration, how important this is for people with diabetes to have effective and affordable insulin,” Vigersky continues. “I think the Society and its members need to continue to advocate and pound that message home, and get the individual physicians, the endocrinologists, as well as their patients up in front of their representatives and make the case.”

It’s going to take pressure, and it’s going to take time. That, and everyone coming together to make the effort so that by 2121, we won’t have to read stories about 20-year-olds dying from not being able to afford a very old, very essential drug.

“Insulin pricing is complex and there are many stakeholders in the supply chain,” Kalyani says. “It will require all parties involved including manufacturers, pharmacy benefit managers, healthcare providers, pharmacies, administrators, and employers to come together to address this problem.”

Bagley is the senior editor of Endocrine News. In the October issue he wrote about the unusually high rates of fatty liver disease in Mexican American populations compared with other Hispanic American populations.