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Insulin was invented to be affordable for most everyone, but patients continue to struggle for a key part of treating their diabetes.
It's estimated nearly 6 million Americans with diabetes receive insulin; an estimated 1.5 million with type 1 diabetes need insulin to survive.
Patients may complain about the price and those who can’t afford it buy it on the black market, trade insulin types on Facebook and in other closed online groups or even resort to online personal fundraising.
Irl Hirsch, MD
"The original patent for insulin was sold to the University of Toronto for $1 and a handshake, and profit was not a primary goal," says Irl B Hirsch, MD, a professor of medicine and the Diabetes Treatment and Teaching Chair at the University of Washington School of Medicine. The medication's discoverers then joined forces with Eli Lilly to take regular insulin to mass production in 1923. Neutral protamine Hagedorn (NPH) insulin was later created in 1946.
Now analogue insulin is produced by genetic engineering, essentially by "programming" bacteria, Hirsch, who has type 1 diabetes, told Medical Economics. "It's actually very cheap to make, considering its cost on the open market."
And this year, insulin prices took over the front pages of newspapers as the top three insulin manufacturers raised prices more than 240% over the past decade.
Here's how physicians and their patients can navigate insulin's choppy waters.
When patients say, "I can't afford my insulin," Hirsch says it's usually due to one of four factors:
1. Among patients with insurance from the Affordable Care Act (ACA), deductibles may now be out of reach for those on high-deductible plans. "These may run $3,000 to $6,000-the state of Wyoming has an ACA family plan with a deductible of $12,700."
2. Medicare (Part D) patients are in the medication “donut hole” early in the year and pay full price for insulin.
3. Younger patients are suddenly cut from the cord of parental insurance and find themselves unprepared to navigate the complex red tape of the insurance system.
4. Patients simply can't afford high co-pays that accompany the high cost of insulin.
Insulin prices rise, but strangely enough, drug companies say they don't really expect patients to pay the actual cost, says Hirsch. In terms of how this works with payers, commercial health insurance companies partner with a pharmacy benefit manager (PBM) for prescription benefits.
PBMs hired by employers negotiate discounts or rebates with manufacturers for those health plans or employers to increase revenue and decrease total member costs. Rebates, however, are usually based on formulary access, so the negotiated rate depends on whether the insulin is on that formulary list. The percentage of the rebate is based upon the retail price of insulin.
"Let's say I want to give a patient Lantus," says Hirsch. "The PBM can tell me, 'No. We don't have a negotiated rate with Lantus, so use Basaglar or Tresiba.' That means the insulin that's best for my patient isn't available, or at the very least, conversion to the different insulin can be messy."
Kickback schemes have been reported around rebates, he says, as well as concerns about collusion and antitrust law violations.
"Thirteen times in a two-year period, one particular insulin went up in cost, and each time, within 24 hours, another also did," says Hirsch of two whose total sales were recently counted at $11 billion. This is called "shadow pricing."
"A patient with a high deductible must use the insulin on that plan, but first must spend that $4,000 out of pocket. Consider that Lantus is $300 a vial and maybe a patient uses two per month-many can't pay that," he says. "Patients in the Medicare donut hole also must pay the full retail price of insulin."
Finally, the uninsured find themselves in a similar insulin-purchasing pickle. "As of September 30, 2017, 12.3% of Americans have no health insurance," Hirsch says. "Some patients ration insulin and others just stop using it."
1. Use human NPH or regular insulin.
Most patients do just fine, says Hirsch. "The price at a major drug retailer may be $125 per vial. Get the same exact product at Walmart for $25 a vial. That retailer also sees this as a way to bring patients into the store who might not otherwise come."
2. Educate physicians and patients.
Physicians: Those trained after 2002 may not know much about this, he says. "Training is needed to prevent poor outcomes when switching patients' insulin." He also recommends this protocol for all physicians, no matter their level, and urges professional and advocacy societies to take on the charge.
Patients: Neither NPH or regular insulin requires a prescription in the United States-or anywhere in the world. No prescription is needed to buy any insulin in Canada, Hirsch says, where it is usually priced around $30 to $35.
If the cost of insulin in the U. S. seems unreasonably high, consider these 2013 statistics, says Hirsch.
· The U.S. and Canada use 12% of the world's insulin, but fund 52% of insulin revenues.
· China uses 25% of the world's insulin but funds 4% of insulin revenues.
"The rules of supply and demand are definitely not at work here," Hirsch says.