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Persistent shortage of growth hormone frustrates parents and clinicians

Winston Hall, 9, needs growth hormone to manage symptoms of Prader-Willi syndrome, a genetic condition. A shortage of the medicine has contributed to behavioral issues that led him to be sent home from school.
Bridget Bennett for NPR
Winston Hall, 9, needs growth hormone to manage symptoms of Prader-Willi syndrome, a genetic condition. A shortage of the medicine has contributed to behavioral issues that led him to be sent home from school.

Dr. Jennifer Miller has been an author of dozens of studies about rare endocrine diseases over the last two decades. Hundreds of patients fly to Gainesville, Fla., from all over the U.S. to see her for treatment.

But now, her office is inundated with faxes, emails, texts and phone calls that have little to do with her life's work. Miller, a professor of pediatric endocrinology at the University of Florida's College of Medicine, has research papers in her inbox that just need a few finishing touches before publication in medical journals. She doesn't have time for them.

A shortage of growth hormone — as well as how insurance companies are handling the problem — has consumed nearly every spare minute she has had for the last six months.

Norditropin, the growth hormone prescribed most often, went into shortage in the fall of 2022. It's still scarce a year and a half later, despite assurances from Novo Nordisk, maker of the drug, that supplies would stabilize in 2024. As people try to switch to other brands, a ripple effect has been causing shortages of those products too.

Children feel the effects of drug shortage

For Miller's patients, 500 of whom have a rare disorder called Prader-Willi syndrome, it has been devastating. Without the injectable drug, they are always hungry, causing blood sugar and behavioral problems, weight gain and other complications.

"These kids are suffering. And it's not OK," she says. "It's overall just a horrendous situation because they're eating more, they're gaining weight more, you know, and they're having a ton of behavioral problems. And it's been a huge issue for us to not be able to get growth hormone for some of these people for over six months now."

Growth hormone is prescribed for conditions like growth failure due to a hormone deficiency, short stature due to various genetic conditions, and Prader-Willi syndrome. Sometimes, it's needed only for the years a child is growing. But for others, like Prader-Willi patients, it is a lifelong treatment.

"People think: 'Growth hormone. Oh, big deal, right? It's for growth. Who cares if you don't have it?' But that's not the point," says Miller. "They're having actual physiologic consequences from not being on growth hormone. And to me, that's just not acceptable."

Prior authorizations compound the problem

To make matters worse, insurance companies are making patients and clinicians jump through extra hoops to get the drug — even during the shortage.

Most insurance companies require a prior authorization for growth hormone, meaning health care providers need to justify their prescription with the insurance company before the company will cover the drug, allowing the pharmacy to dispense it to the patient. The process can take days or weeks, which is cumbersome but at least was required only once or twice a year for most families.

Now that the drugs are in shortage, patients and doctors are chasing whatever size injection pen and whatever brand is available. That triggers insurance companies to ask for a new prescription and new prior authorization every time patients need to switch gears and ask for a different pen size because their normal one is out of stock.

"It's just we're switching pen sizes because that's what's available at the moment," Miller says. "And so we spend all day doing these prescriptions and prior authorizations. And then by the time the prior [authorization] is processed, 48 hours later, oftentimes that is out too."

Karen Van Nuys, a health economist at the University of Southern California who has studied prior authorizations, says they have increased dramatically for all kinds of drugs in the last 10 years. "As you might imagine, doctors hate this process," she says. "It's incredibly time-consuming on their part and keeps them from doing more patient-focused work and introduces delay."

Now that growth hormone is in shortage, it's particularly cumbersome.

Some families say they have been through five prior authorizations in one month before they could get pens shipped to them. Others were told to have their doctors resend prescriptions multiple times only to be told there was no drug at all. And some paid for drugs they never got.

Hillary and Jeff Hall were able to get a supply of Omnitrope, a growth hormone, from Mexico. But the medicine cost $1,400 and wasn't covered by the Las Vegas family's insurance.
/ Bridget Bennett for NPR
/
Bridget Bennett for NPR
Hillary and Jeff Hall were able to get a supply of Omnitrope, a growth hormone, from Mexico. But the medicine cost $1,400 and wasn't covered by the Las Vegas family's insurance.

Hillary Hall, who lives in Las Vegas, has spent hours on the phone trying to get growth hormone for her 9-year-old son, Winston Hall, who has Prader-Willi syndrome.

"I'll get it one month, and then they're like, 'Oh, well, we're out of that pen now. Now we need a new prescription and a new pre-authorization,'" she says. "That's not just like an overnight process. It's like a couple-of-weeks thing. And then by the time they mail it out to me, you know, we're talking three weeks."

Winston wasn't able to get any growth hormone for three months. The behavioral consequences became especially bad.

"He was getting kicked out of school once a week for the last three weeks," Hillary says.

"He has a hard time getting through the day without having outbursts and things like that," says his father, Jeff Hall. "They send him home because he's had a breakdown and, you know, like tearing stuff off walls."

They eventually went without their insurance and bought Winston a 30-day supply of growth hormone from Mexico for $1,400.

Challenges remain, despite some improvement

Novo Nordisk says it is "taking every action possible" to ramp up supply, which it says has become more consistent since earlier in the shortage. It also says it's working with insurers and specialty pharmacies to simplify their processes for dispensing medicines.

The company said in an email to NPR on March 20 that it was temporarily discontinuing one of its pen sizes to focus on the others. It expected to continue to have supply problems for at least a few more months.

NPR asked all three major pharmacy benefit managers, which handle prescription drugs for insurance companies, why they're still requiring new prescriptions and prior authorizations every time a patient switches during the shortage.

Members of the Hall family pose for a photo at their Las Vegas home: parents Hillary and Jeff and children Winston (from left), Maggie and Walker.
/ Bridget Bennett for NPR
/
Bridget Bennett for NPR
Members of the Hall family pose for a photo at their Las Vegas home: parents Hillary and Jeff and children Winston (from left), Maggie and Walker.

In an emailed statement, CVS Caremark defended its decision to keep prior authorization in place for growth hormone. The statement said that prior authorization can help keep costs down for employers sponsoring their employees' health plans and that the Food and Drug Administration doesn't consider different brand names interchangeable, requiring a new prescription when patients switch brands because one is out of stock.

Express Scripts said it has offered plan sponsors, such as employers, some options to help patients during drug shortages in general: "That may include recommendations on additional preferred formulary alternatives, and in some cases, preapproving alternatives for the impacted medications to minimize extra steps for prescribers and patients." It didn't say what it was doing specifically for the growth hormone shortage but added that the company is in touch with the manufacturers and hoping the shortage will be resolved "in the coming weeks."

Optum Rx said that it has "made several formulary and utilization management changes to ensure members have access to somatropin products. This included adding more [growth hormone] products to [the] formulary and allowing members to switch among formulary [growth hormone] products and strengths without generating additional prior authorization reviews."

That seems to be some progress, says Miller, the University of Florida doctor. As recently as February, Miller said, not a single insurer had taken the step of removing the prior authorization requirement during the shortage.

Copyright 2024 NPR. To see more, visit https://www.npr.org.

Sydney Lupkin is the pharmaceuticals correspondent for NPR.
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