July 18, 2019 -- Like many Americans, Lija Greenseid comes home with souvenirs when she visits other countries for work or vacation.
Greenseid brings home insulin.
Israel, Italy, Germany, Greece, Taiwan and Canada -- all countries where she's bought insulin for her 13-year-old daughter at a fraction of the price in the U.S., even with health insurance. She's part of a group of people with diabetes and their parents who regularly caravan 5 hours each way from St. Paul, MN, to buy the life-saving medicine in Canada.
On a trip across the border this spring, six of them spent $1,265 on insulin supplies that would have cost them $12,400 back home.
"We saved over $11,000 by going to Canada," says Greenseid.
It's just one example of how far Americans are going to buy insulin, the price of which, on average, tripled between 2002 and 2013. One popular drug, NovoLog, increased in list price by 353% from 2001 to 2016. Insulin cost is a big reason the average annual per-patient spending on treatment for type 1 diabetes increased from $12,467 in 2012 to $18,494 in 2016.
Some families raise the money however they can. Other people with diabetes take older forms of insulin like that available for $25 at Walmart, or ration what they have -- a particularly risky strategy. One survey revealed that 45% of diabetes patients had gone without insulin because of the price.
And many, though it's unclear how many, go to Canada, which insulin activists say is a sign of a broken system in the U.S.
Greenseid's daughter was diagnosed with type 1 diabetes at age 7. She is able to live a normal, happy life. But because the family has a high-deductible health plan that doesn't cover the long-acting insulin that is most effective for her, that life often costs as much as $700 a month for insulin, on top of other costs like blood sugar test strips.
"We're able to purchase it at a lower price in Canada and elsewhere because those countries have put laws into place to make sure the citizens of their countries can buy it at an affordable price," Greenseid says.
"Instead of a system in which you can buy it easily and affordably, we have a system in which increasingly, more people are having to pay close to list price, which is too much money."
A Medical Triumph
The discovery of insulin was one of the great triumphs of modern medicine, often compared to the discovery of penicillin. It is also one of medicine's great feel-good stories.
In people who have type 1 diabetes, the pancreas cannot make insulin, a hormone vital to keeping blood sugar steady. Without insulin, people can get nerve damage, blindness, heart problems, and they can die from ketoacidosis. Of the estimated 30 million Americans with diabetes, 7.4 million have type 1 and need insulin to maintain their health.
In 1921, Canadian scientists Frederick Banting and Charles Best synthesized animal insulin, selling their find to the University of Toronto for $1 each, in hopes of ensuring life-saving treatment for all who needed it.
Irl Hirsch, MD, is a professor at the University of Washington School of Medicine and one of nation's foremost diabetes experts. He also has type 1 diabetes and remembers paying 75 cents a vial in the 1960s.
"Two Mondays ago, I saw 15 patients, and seven were getting insulin from Canada," says Hirsch. "We've never had a situation where people are stretched so thin to purchase a medication they need to stay alive."
He doesn't exclusively blame drugmakers -- there are three companies that make insulin products in the U.S. -- but also the nation's opaque medication pricing system. Pharmacy benefit managers control which insulins are on an insurer's list of approved drugs and receive rebates from manufacturers to do so. They can exclude a drug if the rebate is too low. The result is that what one person pays for insulin could be vastly different from what another pays.
"You can think of it as a tax. ... By the time the insulin gets from the factory where it's made until it comes all the way down the chain to the patient, there are a lot of people who touch the insulin, and everyone wants money for touching it,” Hirsch says. “One of the things that's different in other countries is not as many people touch the insulin before it gets to the patients, so that keeps the costs down.”
According to T1International, a U.K.-based advocacy organization for people who have diabetes, Americans pay more for insulin than people in any other nation.
Dangers of Insulin Rationing
Alec Smith was diagnosed with type 1 diabetes older than most, at the age of 24. The cost of insulin and other supplies was $250 a month, expensive but bearable.
Then he had to get off his mother's insurance at the age of 26 and, unable to find a reasonable plan, tried to go to the pharmacy and pay out-of-pocket. The cost was $1,300 for a month's supply.
"He left without anything, thinking he could make what he had in his supplies last until payday," says his mother, Nicole Smith-Holt, of Richfield, MN.
"He died about 4 days before his paycheck."
The cause of death was ketoacidosis, when the body can't use sugar in the blood for energy so it burns fat and muscle instead, making high levels of acids called ketones build up. Lack of insulin causes ketoacidosis. "Almost on a daily basis, people are reaching out to me [through social media], saying they're facing the same type of struggles. I'm hearing about people who are not able to test their blood sugars on a daily basis," says Smith-Holt.
Hirsch, the University of Washington doctor, says such cases highlight the dangers of rationing insulin.
"Whether you have type 1 or type 2 diabetes, you are going to end up with higher blood sugars. And over periods of time, that can result in really bad downstream effects. But it's much worse than that," he says.
Skipping doses could lead to vision, kidney, and nerve damage over time. And when patients have the symptoms of ketoacidosis -- confusion, dehydration, frequent urination, muscle weakness, and eventually coma and death -- insulin is the only thing that can help them.
Turning to the black market for insulin could be equally dangerous, and it's something Hirsch never advises his patients to do.
"It's like heroin or cocaine. You don't know what you're getting. It could be dirty. It could be laced. I would never recommend that," he says.
Another option is older forms of insulin, such as the type sold at Walmart for $25. But these require strict meal planning and multiple daily shots, and they don't work for everyone. In fact, Hirsch says, many doctors don't know much about these and prescribe them less frequently than newer, longer-acting insulins.
Smith-Holt says Alec and his doctor decided an older insulin wouldn't work with his busy job and active lifestyle. She likened such insulins as a "two-tiered system of care."
"The poor people get the old, less-effective, hard-to-manage insulin, whereas the people who can afford it, they get the top-of-the-line insulin that's easier to manage. It's sad that our system is coming to that situation," she says.
For his part, Hirsch has been railing against the system of insulin prices for years. Just Google "Irl Hirsch" and "rant." And he is not optimistic about a change.
"The reality is there is unfortunately so much pressure from the pharmaceutical industry and from the pharmacy benefit managers not to change the way things are," he says.
"I don't see this changing any time soon until there are a lot more people who die."
Others, meanwhile, are taking the industry on.
Karyn Wofford, 29, a writer from Atlanta, is also a regular visitor to Canada. Wofford has type 1 diabetes but also has a high-deductible insurance plan, so she pays out-of-pocket until reaching her limit. She must then contribute a hefty copay. Costs change constantly, but she is now paying $1,000 a month for Humalog, which forces her to ration her doses.
"But we can fly to Canada, stay in a hotel for the night, and buy insulin for a year for less than what a 3 months’ supply here would cost," she says. "It's really hard to already have a disease that's extremely hard to manage because it's such a complex disease, then you start shaking up these basic things we should have, changing the foundation of our care. It makes it almost impossible to manage it at this point," she says.
She is one of more than a dozen people across the country who have filed a lawsuit against drugmakers, alleging price-fixing and inflated costs by the companies and pharmacy benefit managers, and saying that when the price of one insulin drug goes up, the others do as well. The suit has yet to go to trial.
Greenseid, the parent in Minnesota, doesn't see the cross-border caravans as a solution to the insulin price problem.
Though it is illegal to import prescription drugs, the FDA allows the caravans to go on. Still, Greenseid remembers feeling anxious the first time she came back across and told the U.S. border agent she had bought insulin.
"'Do you have any alcohol, tobacco, or firearms?'" the agent responded. "That was it. He didn't even blink, didn't ask how much or to see it. I have a feeling in these border towns, they probably see Americans going across the border to buy prescription medications regularly."
Greenseid sees the well-publicized caravans as a way to raise awareness of the issue and get by in the meantime. Action, she says, needs to come from lawmakers.
"The pharmaceutical companies, the pharmacy benefit managers, the insurance companies, they're for-profit companies. ... They're doing what they're supposed to do. They're supposed to be making money and returning that to their investors. I really firmly believe it is a lack of political will and it is our elected officials who are to blame for allowing the system to be perpetuated to the point where so many Americans can't afford their prescription drugs."
Colorado State Rep. Dylan Roberts lost his younger brother when he had a diabetic seizure and fell.
While insulin affordability was not a factor in his death, the lawmaker was inspired to do something no state had done before: cap insulin prices. This spring, his bill was signed into law, capping the monthly copay any state resident must pay at $100 -- no matter how much they need -- and directing the state's attorney general to investigate insulin pricing.
"The pharmaceutical companies are benefiting from a very complex and secretive pricing scheme that we have in the United States for prescription drugs," Roberts says. The price of insulin, he says, "is not tracking with any sort of inflation. ... That is extortion, and they certainly are experiencing record profits from it."
He acknowledges the new law has limitations -- it doesn't apply to those on Medicare or Medicaid or the uninsured -- but he is encouraged by the national attention it has received. He says lawmakers in a dozen other states have contacted him, eager to learn more and to pass similar legislation in their states.
"This isn't a long-term solution. This is a short-term solution for the people who are really struggling with prices and rationing insulin and having adverse medical consequences," he says. "If we're ever going to actually solve this problem -- not just for insulin but all prescription drugs -- leadership has to happen on the federal level, from Congress."
In Kentucky, the state's attorney general has filed a lawsuit against the companies that make insulin, alleging a "cynical and deceptive pricing scheme." And this spring, U.S. Sen. Tina Smith, D-MN, introduced legislation to remove barriers to bringing lower-cost insulin to the market.
And an online petition by the American Diabetes Association calling for "increased transparency and more affordable insulin" has collected more than 487,000 signatures.
Insulin is not the only medicine to increase in price dramatically in recent years. One recent study in the Journal of the American Medical Association found that, "Although prices are often justified by the high cost of drug development, there is no evidence of an association between research and development costs and prices; rather, prescription drugs are priced in the United States primarily on the basis of what the market will bear."
Jon Florio, U.S. diabetes communication manager for Sanofi, the maker of Lantus and Apidra, says, "Since 2012, the net price of Sanofi insulins has declined by 25%, yet patient out-of-pocket costs have continued to rise. Over the same period, the price of our most prescribed insulin, Lantus, has actually fallen over 30%, while average out-of-pocket costs for patients with commercial insurance and Medicare has risen approximately 60%."
Florio said that in 2017, the company pledged to keep annual list price increases at or below a federal projected growth rate.
He also cites Sanofi's programs that patients can sign up for to limit insulin prices regardless of income.
Eli Lilly, the maker of Humalog, did not respond to requests for comment. The drugmaker has launched a program offering the medication at a 40% discount and recently announced it will release a generic version of Humalog for half the price. And Novo Nordisk, the maker of NovoLog, has pledged to limit future price increases.
"We know that the public has an impression that companies like ours realize all the profits from the 'list price' increases we've made over the last decade," says Ken Inchausti, director of corporate communications for Novo Nordisk.
He says common perception is that when Novo raises the list price by some percentage, the company’s profit rises by the same percentage. That’s misleading, he says. While the company does set the list price, “we negotiate with the companies that actually pay for the medicines, which we call payers. This is necessary in order for our medicines to stay on their preferred drug list or formulary. The price or profit we receive after rebates, fees, and other price concessions we provide to the payer is the net price. The net price more closely reflects our actual profits."
Inchausti also cites the complex rebate system with pharmacy benefit managers, or PBMs.
"PBMs and payers have been asking for greater savings, as they should. However, as the rebates, discounts, and price concessions got steeper, we were losing considerable revenue -- revenue we use for R&D, sales and marketing, education, disease awareness activities, and medical information support,” he says.
The company, Inchausti says, would continue to raise the list price to offset the higher rebates, discounts, and price concessions in order “to maintain a profitable and sustainable business.” The company also watches market trends to be sure its drugs were priced competitively. “All in all, we've simply tried maintaining a profit margin that has been dropping significantly since health policy changed in the U.S."
Novo Nordisk and Sanofi deny allegations of price-fixing among the insulin makers.
"Our pricing decisions are made independently and based on a number of different factors,” Inchausti says. “As with any manufacturer, we monitor market dynamics and our competitors’ pricing through public and subscription databases that track list prices."
But Greg Lopes of the Pharmaceutical Care Management Association (PCMA), which represents pharmacy benefit managers, says drugmakers and lack of competition are responsible for rising costs.
“Drugmakers are solely responsible for setting and raising prescription drug prices,” Lopes, assistant vice president of strategic communications for the PCMA, said in a statement.
“The most important barrier to lower-cost insulin products is the lack of biosimilar and generic competition. PBMs can only negotiate lower prescription drug costs on behalf of health plan sponsors and patients when there is sufficient competition among brand-name drugs, generic and biosimilar competitors, giving manufacturers an incentive to provide discounts.”
He said that pharmacy benefit managers have introduced new programs to cap out-of-pocket costs on insulin and that they offer real-time prescription drug coverage information to doctors and consumers.
For her part, Greenseid, the mother in Minnesota, is encouraged by the national attention on insulin prices.
"We are starting to break through the shame of not being able to afford health care," she says. "Americans for a long time have been quiet about it because some feel it's a personal failure on their part, because they're not able to take care of their family like they need to."