Splashing around in the pool, skin slick with sunscreen, Shane Butcher was a normal 9-year-old kid on a perfect summer day.
And then he wasn't.
He floated toward the edge of the pool, energy suddenly replaced by a vacant expression, his blood sugar plummeting so low he didn't respond when his mother screamed his name.
Constant vigilance over blood sugar levels is routine for children with type 1 diabetes and their parents. But one of Shane's insulins had recently been replaced with a new brand because of shifting insurance rules. Ever since, the formerly easy undulation of his sugar levels had turned into an unpredictably wild ride.
Shane's parents pulled him out of the pool, pumped him full of sugary juice, and when his blood sugar tested low again, squirted more down his throat.
Out of other options, Liz Parlett Butcher raced to retrieve a vial of glucagon, a hormone the pancreas normally reduces when insulin is too low. She injected it into her son's upper arm, and he came back.
"It was the most traumatic and godawful experience," she said of the episode, still fresh in her mind even after a full year.
As drug prices continue to rise, insurers and the pharmacy benefit managers (PBMs) that handle medications for many health plans are aggressively exerting control. Hundreds of drugs have been dropped from insurers' lists of covered medications in favor of cheaper alternatives, such as a new generic or a competing brand offered at a steep discount. Pricey drugs that remain on insurers' formularies often can be had only after patients try cheaper ones and can prove they aren't working as well, a process called step therapy.
"There's a growing arms race between the pharmaceutical industry and the insurance industry," said David Whitrap, a spokesman for the Institute for Clinical and Economic Review in Boston. "Patients can sometimes get stuck in the middle."
‘Not a guinea pig’
For the Butchers, it started last summer, when the family received a notice from UnitedHealthcare, one of five insurers that manage Medicaid plans in New Jersey. The insurer would no longer cover Lantus, an insulin Shane, the oldest of the family's four children who was diagnosed with diabetes at age 6, injected daily. Instead, the plan offered Basaglar, new to the market in 2016.
Like most type 1 diabetics, Shane, now 10, uses two types of insulin — a short-acting version administered to balance the carbs he eats during the day, and a long-acting version taken at night.
The last time their insurance plan changed the brand of short-acting insulin it covered, Shane gained 10 pounds and had gastrointestinal problems, and his sugar levels were erratic.
Neither Shane nor his parents wanted to risk that happening again.
"My son is not a guinea pig. He's not your laboratory rat. He's a child, and he has enough to deal with," Butcher said.
But insurers, too, are trying to avoid risk. A vial of Lantus cost $307 in 2017, up nearly 250 percent in just a decade, according to Kaiser Health.
"In an environment of rising drug prices, we are always looking at ways to offer clinically proven drugs that support improved health outcomes for consumers and are cost-effective. That is why we explore different brands of medications that can support the same type of therapy," said Jocelyn Parker, a UnitedHealthcare spokeswoman, in a statement.
Basaglar contains the same active ingredient as Lantus, but was less expensive for UnitedHealthcare to offer, Parker said.
Gary Scheiner, a certified diabetes instructor who is owner and clinical director of Integrated Diabetes Services in Wynnewood, said that because the active ingredient – insulin – is the same in the two drugs, a switch would be OK for many patients.
But the inactive ingredients that make up the solution the insulin is mixed in vary, potentially affecting absorption in certain patients. This variation is more pronounced in long-acting insulins, said Scheiner, who has not treated Shane.
Finding a brand that's a match can be especially important for type 1 diabetics, whose bodies do not produce any insulin – unlike type 2 diabetics, who may use injected insulin to supplement their own production.
Skyrocketing list prices of drugs have set off behind-the-scenes negotiations that consumers don't see — though they often feel it later, when a medication they need isn't covered.
With their millions of members as bargaining clout, insurers and PBMs demand that pharmaceutical companies offer deep discounts in exchange for their drugs to be included in formularies and ranked favorably as a preferred drug, said Richard Evans, general manager of SSR Health, an investment research and advisory firm in Montclair, N.J.
Drug makers can push back by agreeing to discounted prices on the condition that formularies offer their brand exclusively.
For Medicaid plans, manufacturers are required to discount prices by 23.1 percent or match their best discount in the commercial marketplace, whichever is greater, Evans said. Medicaid plans get an additional discount because of rules that prohibit manufacturers from inflating prices beyond the Consumer Price Index, which measures the middle market value of any given product.
Medicare Part D also negotiates discounts for members.
These dealings add to the mystery of pharmaceutical prices.
A one-year supply of Basaglar has an average net price of $1,310, compared with $2,009 for Lantus, according to SSR's analysis, which did not include Medicaid prices because they are so deeply discounted. That's a difference of $58 a month, which may not seem significant to consumers.
But on formularies where Basaglar is the preferred option, its price is likely well below the average, Evans said.
"It's standard rules of the game for drug pricing," he said.
Health plans often allow patients already stable on a drug to stick with it when the formulary changes, requiring only members newly prescribed the drug to follow its step therapy, said Whitrap, of the Institute for Clinical and Economic Review.
Electronic formularies that make it possible for doctors to write prescriptions according to what's covered by each patient's insurance can also help avoid such problems, he said.
"When administered appropriately and smoothly, they are effective tools for insurance to steer patients toward more affordable and safer medications," Whitrap said. "Unfortunately there are instances in which these programs are just not administered very well and place unnecessary and onerous hurdles between patients and the medications they need."
For patients who do experience problems, the consequences can be significant.
In a small survey of 1,200 adult patients in Ohio, about a quarter of respondents said they had encountered an insurance-driven medication change, with about 40 percent reporting an adverse medical outcome, such as missed doses, forgoing the medication, and trips to the emergency department.
Problems were most common among patients whose medications were managing chronic conditions, such as high blood pressure, cholesterol and diabetes.
"It's a concern for patients because we're talking about disease classes which are about life and death," said Mark Rood, a physician at the Cleveland Clinic, who was working as a research fellow at Case Western Reserve University when he co-authored the report in 2012.
‘Insulin is my key’
Because of Shane's past experience, Butcher asked his doctors at Children's Hospital of Philadelphia to request approval from UnitedHealthcare to keep Shane on Lantus. The doctors' requests were denied twice.
To be approved for Lantus, the insurer told them, Shane had to first try Basaglar.
In response to questions from the Inquirer, Parker, of UnitedHealthcare, said that if a member experiences adverse effects to a prescribed drug, the doctor can work with the insurer to get authorization for another treatment option.
Tom Hester, a spokesman for New Jersey's Department of Human Services, which oversees Medicaid, echoed Parker, saying the program "works with families to ensure they're fully informed of their options and have access to safe, effective and appropriate treatments — and that any concerns are addressed quickly and effectively."
So Shane tried Basaglar. It didn't go well.
Within a few weeks, Butcher noticed Shane's blood sugar levels were often low before bed, after he'd taken his dose of Basaglar.
Butcher thought she and Shane just needed to find their stride with the right dosage and timing. Physical activity, summer heat and puberty all affect how a body absorbs insulin.
"Just like a car that needs a key to work, the body needs insulin to work. Insulin is my key," said Shane, a race car fanatic. When his insulin levels are off, he said, he feels "like a zombie."
But after his incident in the pool, and a similar episode during a sleepover at his grandmother's house a few weeks later, Butcher was convinced the drug was the problem.
"Unless you live it and go through the emotions every day, you don't understand it. Managing type 1 is an art," Butcher said.
Shane's doctors tried again to get approval for Lantus and this time, able to show he'd failed with Basaglar, they succeeded.
Stories like Shane's have caught the attention of lawmakers looking to address step therapy rules.
"It's being forced upon those in the most need, who are suffering from different diseases and should not be required to go through a long process that can affect their overall health — not to mention there's an emotional factor," said Assemblyman Kevin Rooney, a Republican from Passaic County, N.J.
Rooney is the prime sponsor of a bill that would limit step therapy by establishing a clearer way for doctors to override insurers' prescription preferences if they think a certain medication is in their patients' best interest.
Butcher is pleased to hear of such efforts, but she has more immediate concerns.
In May, another notice from UnitedHealthcare came in the mail. The insurer plans to switch the brand of short-acting insulin Shane is on, starting Aug. 1.
Update: After Shane's story ran in the Inquirer in July, UnitedHealthcare gave a 20-year guarantee to Shane's insulin coverage. Read the follow up story here.