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 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.
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.
Transcript:
ARI SHAPIRO, HOST:
Families are hunting for a scarce medicine to treat a rare childhood disease. This nightmare for parents started more than a year ago. When NPR first reported on this last May, the maker of the growth hormone said it would be back in stock by the end of last year. That didn’t happen, and now health insurance hurdles have made the situation even worse. NPR’s pharmaceuticals correspondent Sydney Lupkin is here to explain. Hi, Sydney.
SYDNEY LUPKIN, BYLINE: Hi, Ari.
SHAPIRO: What is this drug, and why can’t people get it?
LUPKIN: So the drug at the center of the problem is called Norditropin, and it’s a growth hormone used to treat several rare diseases. So when it went into shortage in the fall of 2022, there were ripple effects. As people switched to other brands, then those drugs went into shortage, too.
SHAPIRO: So how are families whose children have this rare disease handling it?
LUPKIN: They’re basically chasing whatever growth hormone they can find with very little information to go on. This drug is sold as an injector pen that comes in different sizes, and then that’s used until it runs out. So the dose doesn’t change, but the overall container size does.
Here’s how it goes. The doctor writes a prescription for one injector pen size, but the patient doesn’t find out if it’s out of stock until the pharmacy says, you know, we don’t have it. So then the patient has to go back to their doctor and ask them to write a new prescription for another size pen. And often, that won’t be in stock either. And it kind of goes on and on. But there’s another wrinkle, and it’s called prior authorization.
SHAPIRO: This sounds like a nightmare. And prior authorization – this gets to the health insurance wrinkle that I mentioned. How does prior authorization actually work?
LUPKIN: So it’s basically a tool to keep costs down for insurance companies. In this case, the doctor writes a prescription, and then the insurance company asks the doctor to justify that decision before insurance will pay for the drug, allowing the pharmacy to dispense it. Here’s Karen Van Nuys at the University of Southern California, who has studied prior authorizations and found that they have increased dramatically for all kinds of drugs in the last 10 years.
KAREN VAN NUYS: As you might imagine, doctors hate this process. It’s incredibly time-consuming on their part and, you know, keeps them from doing more patient-focused work and introduces delay.
LUPKIN: Sometimes, prior authorizations take a day or two. And other times, it takes much longer – weeks. So now that the growth hormone is in shortage, it’s particularly cumbersome.
SHAPIRO: Because if they’re looking for different versions or different sizes, they need a new prior authorization every single time?
LUPKIN: Almost every time. Here’s Dr. Jennifer Miller, an endocrinologist at the University of Florida who sees kids from all over the country who need this drug.
JENNIFER MILLER: You know, the insurance companies require a new prior authorization every time you switch growth hormone. Whether it’s from Norditropin 5 milligram pen to Norditropin 10 milligram pen, you still have to get a new prior auth. Even though it’s the same medicine, same dose, it’s just we’re switching pen sizes because that’s what’s available at the moment. And so we spend all day doing these, you know, prescriptions and prior authorizations. And then by the time the prior auth is processed 48 hours later, oftentimes that is out, too.
LUPKIN: It takes a huge chunk of her time. She’s a prominent specialist who treats and researches a rare genetic condition called Prader-Willi syndrome. The people who have it don’t process food normally. They’re always hungry, have blood sugar problems, physical issues and behavioral issues. Since the growth hormone shortage began, Miller has had to put her research on hold to deal with insurance companies. I’ve heard from families who have been through five prior authorizations in one month before they could get a pen shipped to them.
SHAPIRO: That sounds like such a huge headache. What does it mean for the kids who have these conditions?
LUPKIN: It can vary. For people with Prader-Willi, it has serious consequences. I spoke to the Hall family, who are under Dr. Miller’s care, about that.
SHAPIRO: All right. Let’s listen to some of your conversation with them.
LUPKIN: Hillary Hall says she’s been chasing prescription after prescription, prior authorization after prior authorization for months to get growth hormone – any growth hormone – for her 9-year-old son, Winston.
HILLARY HALL: 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 preauthorization. And I’m like, great. Unfortunately, it’s not an overnight process. It’s, like, a couple-week thing.
LUPKIN: They couldn’t get the drug at all for three months. For Winston, the behavioral problems are especially bad.
HALL: I mean, my kid’s getting kicked out of school. We were taking his picture the other day, and I was wanting him to hold still, and he just started crying ’cause he couldn’t hold still enough. He just can’t function.
LUPKIN: Desperate, they eventually bought a 30-day supply from Mexico for $1,400. Miller says that patients like Winston need growth hormone like Norditropin their whole lives to keep symptoms at bay. For them, the shortages have been devastating.
MILLER: These kids are suffering, and it’s really – it’s not OK. I mean, 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.
SHAPIRO: That’s reporting from Sydney Lupkin, who’s still with us. And I have to ask why these shortages are happening. What does the drug company that makes Norditropin say about all this?
LUPKIN: So Novo Nordisk, which is the same company that makes Ozempic, says it is temporarily discontinuing one of its Norditropin pen sizes – the 30 milligram – to focus on making the other ones. It expects shortages to last at least a few more months. But I have to say, the company has been pushing back the date for when things will go back to normal over and over again since I first reported on the shortage a year ago.
SHAPIRO: And how do the insurance companies justify making people go back again and again for these prior authorizations, especially when it’s the same drug, same dose, in a different size?
LUPKIN: Mmm hmm. It’s a really good question because it’s also not like the diagnosis will change. Prader-Willi doesn’t go away, you know? I asked the three big pharmacy benefit managers which handle drug claims for insurance companies why they’re doing this, and the answers varied. CVS Caremark basically said its hands were tied by state laws and FDA limitations. Express Scripts says some people’s plans have options, like pre-approving alternative medicines during shortages. Optum Rx actually said it stopped requiring so many prior authorizations because of this shortage. So that’s some relief for patients and doctors, but there’s still a lot making life tough as the shortage drags on.
SHAPIRO: That’s NPR pharmaceuticals correspondent Sydney Lupkin. Thank you.
LUPKIN: You bet.
(SOUNDBITE OF JEAN DU VOYAGE’S “KHANTI”)
