July 25, 2018 -- Gabriella Corley was a normal, healthy little girl: cheerleader, basketball player, full of energy.
Then, in 2014, her parents noticed some troubling symptoms: bed-wetting, frequent urination, insatiable thirst. A visit to the doctor turned into a trip to the emergency room when a test showed her blood sugar was perilously high. Doctors diagnosed the girl, now 11, with type 1 diabetes and gave her the first of what will be a lifetime of insulin shots to keep her alive.
But the Corley family's ordeal was just beginning.
Gabriella started getting welts at the injection site with brand-name insulin Humalog, then NovoLog, so doctors tried Apidra, which finally worked to control her blood sugar. Then came the bill: $250 a vial, because her insurer considered it a tier 3 drug, the mid-range of drug costs. Tier 3 typically includes brand name drugs for which there is no generic alternative Gabriella needed 1.5 vials a month.
The expense was too much for her parents, both public school employees. They turned to the black market, a GoFundMe campaign, insulin-swapping Facebook groups, and whatever else they could afford to keep their daughter alive.
"She doesn't have an option. Without insulin, she dies," says her mother, Andrea Corley, of Elkins, WV. "It's just a tough pill to swallow that an insurance company and pharmaceutical company can be making so much money over medically necessary medication."
It's a dilemma facing people with diabetes and their families across the nation. Insulin prices have skyrocketed in recent years, on average tripling between 2002 and 2013. One popular brand, NovoLog, increased in list price by 353% from 2001 to 2016. Some, like the Corleys, raise the money however they can, while other people with diabetes take less effective insulin or ration what they have. One survey revealed that 45% of diabetes patients had gone without insulin because of the price. And in some cases, the consequences have been fatal.
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 patients with type 1 diabetes, the pancreas cannot make insulin, a hormone vital to maintaining blood sugar to feed the cells of the body. Without insulin to keep blood sugar levels steady, patients can have nerve damage, blindness, heart problems, and they can die. Of the estimated 30 million Americans with diabetes, 7.4 million require insulin.
In 1921, Canadian scientists Frederick Banting and Charles Best created animal insulin, selling their patent 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 has type 1 diabetes and remembers paying 75 cents a vial in the 1960s.
"Yesterday afternoon I saw seven patients, and four of them, because of the expense, were going to Canada to get their medicine," he says. "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 the drugmakers -- there are three companies that make insulin products -- but the nation's opaque medication pricing system. Pharmacy benefit managers control which insulins are on an insurer's list of approved drugs and get 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. 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," Hirsch says.
According to T1International, a U.K.-based advocacy organization for people with diabetes, Americans pay more for insulin than people in any other nation. In 2017, American diabetes patients paid $237 billion in direct medical costs, an average of $16,750 per patient, accounting for 1 in 4 health care dollars spent that year.
Dangers of Insulin Rationing
Alec Smith was diagnosed with type 1 diabetes older than most, at the age of 24. The cost for 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."
He died from ketoacidosis, when the body can't use sugar in the blood for energy, so it burns fat and muscle instead. It leads to the buildup of acids called ketones. The cause is lack of insulin.
"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," Smith-Holt says.
Hirsch, the medical 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 -- insulin is the only thing that can help them. Without it, they can die.
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 found that 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 anytime soon until there are a lot more people who die."
Others, meanwhile, are taking the industry on.
Karyn Wofford dreads going to the pharmacy to pick up her insulin.
"I can research a plan before I choose what we're going to do next year, but there really is no way to know what's going to happen. The uncertainty is one of the worst parts about it," says Wofford, 28, a writer from Atlanta.
Like many Americans, she has a high-deductible insurance plan, so she pays out-of-pocket until reaching the deductible, and then she must contribute a hefty copay. Costs change constantly, but she has been paying $1,300 a month for Humalog, which forces her to ration her doses.
The costs are why she and her husband haven't had children or bought a home. But the uncertainty, from month to month and year to year, of what it will cost her to stay alive might be worse.
"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 a dozen patients across the country who have filed a lawsuit against the drugmakers. The suit alleges price-fixing and inflated costs by the companies and pharmacy benefit managers, saying that when the price of one insulin drug goes up, the others do as well.
The lawsuit is just one way people with diabetes and medical advocates are pushing back against high insulin prices. The U.S. Senate Committee on Aging earlier this year held a hearing on the issue. And an online petition by the American Diabetes Association calling for "increased transparency and more affordable insulin" has collected more than 350,000 signatures.
in 2017, lawmakers in Nevada passed a law requiring more transparency in insulin pricing. It requires drugmakers to disclose information on the cost of making and marketing the medicine to pharmacy benefit managers, who would have to reveal what rebates they offered and how much money they keep.
The Pharmaceutical Research and Manufacturers of America challenged that law in court but this summer dropped its lawsuit after negotiations to allow some information to remain secret. That organization did not respond to requests for comment on this story.
Insulin is not the only medicine to rise in price dramatically in recent years. One recent study determined 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."
WebMD reached out to the three companies that make insulin medications.
Susan Brooks, a spokeswoman for Sanofi, maker of Lantus and Apidra, says the net price of the two drugs "over the last 5 years has actually decreased.”
Despite the net price going down, out-of-pocket costs for some patients are going up.
The price consumers pay for insulin is part of a complicated system of price-setting for prescription drugs in the United States. Manufacturers set a base price for their drugs and then negotiate with third parties known as pharmacy benefit managers. These PBMs are hired by insurance companies.
The PBMs have great power in deciding which brand of drug an insurance company will cover for its customers. Thus, they can negotiate lower prices from manufacturers. For example, if a manufacturer lists a drug at $100 a dose, PBMs might negotiate that price for the insurance companies down to $80. But the consumer -- the one in need of the drug -- would still pay $100 before any insurance coverage.
Drug companies tend to blame the pharmacy benefit managers for the higher price consumers are paying. Insurance companies, meanwhile, largely blame manufacturers.
Brooks, the Sanofi spokeswoman, says the company in 2017 made a commitment to limit price increases "to no greater than medical inflation,” which is the rate at which health care costs in general rise each year.
Eli Lilly, maker of Humalog, has launched a program offering the medication at a 40% discount. And Novo Nordisk, 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. “In other words, a list price increase by XX percent leads to an automatic XX percent profit for the drugmaker. We believe that is misleading, and here's why: As the manufacturer, we do set the 'list price' and have full accountability for those increases."
But, he says, after the company sets the list price, the negotiations with PBMs impact the final costs.
Pharmacy benefit managers demand greater savings, Inchausti says. As the rebates, discounts, and price concessions go up, he says, “we were losing considerable revenue -- revenue we use for [research and development], sales and marketing, education, disease awareness activities, and medical information support.”
To make up that lost revenue, he says, the company would continue to raise the original list price to “maintain a profitable and sustainable business.”
“We also monitored market conditions to ensure our prices were competitive with other medicines as part of our business model. All in all, we've simply tried maintaining a profit margin that has been dropping significantly since health policy changed in the U.S."
He, like the officials with the other insulin manufacturers, says the drug companies do not set prices in tandem with each other.
"Our pricing decisions are made independently and based on a number of different factors,” he says. “As with any manufacturer, we monitor market dynamics and our competitors’ pricing through public and subscription databases that track list prices."
Pharmacy benefit managers, meanwhile, dispute the claim that they are responsible for drug costs going up. Quite the contrary, in fact. According to the, Pharmaceutical Care Management Association, PBMs save consumers an average of $123 per prescription by negotiating lower prices from manufacturers.
For Andrea Corley, Gabriella's mother, the cost situation changed recently when her insurance company removed Apidra from its formulary. It was a blessing in disguise, as the move qualified her for Sanofi's patient assistance program for people who can’t get the drug through insurance. It provides five vials for 5 months, though the 2-hour-drive each way to pick them up at her doctor's office is a hardship. She has also raised $9,975 through her GoFundMe campaign for Gabriella's medical supplies, allowing her to buy an insulin pump that eliminates the need for shots.
But she still worries about the future, especially when Gabriella's medical costs usually top $10,000 each year and insurance plans change with the calendar. She also has to reapply for the assistance program each year and worries she may not qualify for it someday.
Gabriella herself has handled it all "with such eloquence and grace," Corley says. She knows how to watch what she eats and always orders a diet soda, rarely complaining.
"She just does it and deals with it and keeps going. She knows what happens if she doesn't take care of it," Corley says. "She knows how quickly [a diabetes attack] can happen. She does really well, and she's pretty independent in taking care of herself."