Miriam E. Tucker
November 06, 2019
Although steps are being taken to address the insulin pricing "crisis" in the United States, they are incremental and much more work will be necessary to start to make a real difference, write two experts in a new perspective piece.
The article, entitled, "The US Insulin Crisis — Rationing a Lifesaving Medication Discovered in the 1920s", was published online November 7 in the New England Journal of Medicine by Michael Fralick, MD, and Aaron S. Kesselheim, MD, both of whom work in the fields of pharmacoepidemiology and pharmacoeconomics.
The cost per 100 units of regular short-acting insulin was about $1.00 shortly after it was discovered in the early 1920s, they remind readers, and then fell to less than 20 cents in the 1940s, compared to about $18 today.
For an average 70-kg person with type 1 diabetes, 100 units last less than 2 days. And most people also require long-acting insulin.
Irony of Insulin Rationing Based on Safety in 20s vs Based on Cost Today
Back in the 1920s, the rush to obtain the newly available lifesaving substance before its safe manufacturing process had been fully established led to rationing, say Fralick and Kesselheim.
Today in the United States, many patients are forced to ration insulin because of the exponential cost increase, as has been extensively covered by Medscape Medical News.
"That's the unfortunate irony here that now there's also rationing going on in the United States, but for a very different reason," said Fralick, of Mount Sinai Hospital, Toronto, Ontario, Canada, in an audio interview accompanying the published article.
"Many patients can't afford their insulin, with dire consequences" such as diabetic ketoacidosis and death, he lamented.
It's not clear how widespread the problem is from a numbers standpoint because the current studies are specific to individual geographic areas or clinics where the studies have been done, "but certainly this is a pressing problem," he remarked.
The situation stems from a combination of too little competition from just three manufacturers (Eli Lilly, Novo Nordisk, and Sanofi), US laws that allow them to price their products without restriction, and complexities in the manufacture of lower-cost insulin biosimilars or follow-ons compared with nonbiologic generic pills.
"Although the list price of these products is less than that of their brand-name equivalents, it remains unclear whether authorized generics will provide meaningful cost savings to patients," at least in the case of insulin, say Fralick and Kesselheim.
They note that, in Europe, the 2014 approval of Basaglar, Eli Lilly's biosimilar formulation of insulin glargine (Lantus, Sanofi), reduced the price by about 15%.
Physicians should be aware of and help patients access lower-cost alternatives, such as "authorized generics" and the old human insulins – like NPH – if necessary, Fralick advises.
Legislative Steps Taken While Awaiting More Lower-Cost Options
Legislative efforts to address the problem have so far included a Colorado law passed in May 2019 that caps monthly copayments for insulin to $100 for people with insurance, along with that state's attorney general's investigation into insulin pricing.
Similarly, the large US insurance company Cigna has announced it will limit patients' monthly copays for insulin to $25.
Nationally, the bipartisan Emergency Access to Insulin Act, introduced in the US Senate in June 2019, would expand access to insulin by creating state-level assistance programs to provide short-term insulin supplies to individuals with the greatest need.
It would also impose penalties and recurring fees on insulin manufacturers, and would reduce market exclusivity periods for new insulin formulations.
Another bill, the Affordable Drug Manufacturing Act, sponsored by two Democrats, would establish an Office of Drug Manufacturing within the Department of Health & Human Services (HHS) to either directly manufacture or contract with outside entities to manufacture essential medicines including insulin without violating active patents.
According to Fralick, "I think we'll need a little bit more time to see if the bills are going to get traction. I want to stay optimistic of course, but I do worry that there's going to need to be significant reform that takes place in order for insulin prices to become far more affordable."
"I'll remain positive by saying one of the bills that was put forward, the Emergency Access to Insulin Act, was a bipartisan act, so that gives me a bit more confidence."
"But of course that's coming from a Canadian," he said, referring to himself, "who doesn't completely understand the details of US politics."
What About Importing Insulin?
Meanwhile, some patients have decided to travel to Canada to purchase insulin, where a carton sells for about $20 as opposed to $300 in the United States.
The authority to formally permit importation to the United States exists under the Medicare Modernization Act of 2003, as long as the HHS secretary certifies it can be done safely and will actually save money.
This hasn't happened yet, although the current HHS Secretary, Alex Azar, has voiced support for importation from Canada.
Fralick says that it's unclear whether importation from Canada will be formalized, but even if it is, it's not the entire solution.
"We're a small country compared to the United States and there's no way we would have a sufficient supply as things currently stand ... The potential positive is that importation will provide less expensive alternatives, but it can't just be from Canada. Certainly, it would have to be from other countries."
Fralick and Kesselheim, of Harvard Medical School, Boston, Massachusetts, conclude in their article: "If steps to improve competition continue to be insufficient in addressing this crisis, more substantial reforms to the way the United States pays for insulin will be needed."