Winston Hall, 9, needs growth hormone to manage the symptoms of Prader-Willi syndrome, a genetic disorder. He was sent home from school because the lack of medication contributed to his behavioral problems.
NPR’s Bridget Bennett
hide caption
toggle caption
NPR’s Bridget Bennett
Winston Hall, 9, needs growth hormone to manage the symptoms of Prader-Willi syndrome, a genetic disorder. He was sent home from school because the lack of medication contributed to his behavioral problems.
NPR’s Bridget Bennett
Dr. Jennifer Miller is the author of numerous studies on rare endocrine diseases over the past 20 years. Hundreds of patients fly from all over the United States to Gainesville, Florida, for her treatment.
But now her office is inundated with faxes, emails, texts and phone calls that have little to do with her life’s work. Mr. Miller, Professor of Pediatric Endocrinology, University of Florida School of MedicineIn your inbox is a research paper that needs some finishing touches before it can be published in a medical journal. She doesn’t have time for them.
A lack of growth hormone and dealing with issues with her insurance company have consumed nearly all of her free time over the past six months.
Norditropin, the most frequently prescribed growth hormone, ran out in the fall of 2022. A year and a half later, the drug is still in short supply, despite promises from Novo and Nordisk, the drug’s maker, that supplies would be stable by 2024. If you switch to other brands, the ripple effect is that those products are also in short supply.
Children feel the effects of drug shortages
In the case of Miller disease patients, 500 of them have rare diseases such as: Prader-Willi syndrome, it was devastating. Without injectable drugs, they are constantly hungry, leading to blood sugar and behavioral problems, weight gain, and other complications.
“These kids are suffering, and that’s not okay,” she says. “Overall, it’s a scary situation because they’re eating more, they’re gaining weight, they’re having a lot of behavioral problems, and the lack of growth is a big problem for us. Some of these people have been on hormone therapy for more than six months. ”
Growth hormone is prescribed for conditions such as growth failure due to hormone deficiency, short stature due to various genetic disorders, and Prader-Willi syndrome. In some cases, it may only be needed during the child’s growth period. But for others, like Prader-Willi patients, it’s a lifelong treatment.
“People think, ‘Growth hormone. Oh, what a big deal, right? It’s for growth. If we don’t have it, who cares?’ But that’s not the point,” Miller says. . “There are real physiological effects of not giving growth hormone, and to me, that’s unacceptable.”
Prior permission complicates matters
To make matters worse, insurance companies are forcing patients and clinicians to jump through extra hoops to obtain drugs, even when they are in short supply.
Most insurance companies require prior approval for growth hormone. This means that the healthcare provider must prove the validity of the prescription to the insurance company before the insurance company will cover the drug and the pharmacy can dispense the drug to the patient. This process can take days or even weeks and is tedious, but most families only needed it at least once or twice a year.
Due to current drug shortages, patients and doctors are chasing whatever size injection pen, whatever brand, is available. This forces insurance companies to require new prescriptions and new pre-authorizations every time the regular pen is out of stock and the patient switches gears and requests a different size pen.
“We’re just changing the pen size because that’s what’s available right now,” Miller said. “And we spent all day on these prescriptions and pre-authorizations, and by the time we got the pre-authorizations; [authorization] After 48 hours it will be processed and often output as well. ”
Karen Van NuysA University of Southern California health economist who studies prior approvals says that approvals for all types of drugs have increased dramatically over the past decade. “As you can imagine, doctors hate this process,” she says. “This is incredibly time-consuming for them, prevents them from doing patient-centered work, and creates delays.”
That’s especially troubling now that growth hormone is in short supply.
Some families say they went through five pre-approvals in a month before getting their pens shipped. Some said they had their doctors resend their prescriptions multiple times, only to be told they didn’t have any medication at all. Others paid for drugs they were unable to obtain.
Hillary and Jeff Hall were able to obtain a supply of Omnitrope, a growth hormone, from Mexico. But the drug cost $1,400 and was not covered by the Las Vegas family’s insurance.
NPR’s Bridget Bennett
hide caption
toggle caption
NPR’s Bridget Bennett
Hillary and Jeff Hall were able to obtain a supply of Omnitrope, a growth hormone, from Mexico. But the drug cost $1,400 and was not covered by the Las Vegas family’s insurance.
NPR’s Bridget Bennett
Hilary Hall of Las Vegas spent hours on the phone trying to administer growth hormone to her 9-year-old son, Winston Hall, who has Prader-Willi syndrome.
“I’m going to get a prescription filled within a month, and then they’re like, ‘Oh, that pen’s gone. Now I need a new prescription and a new pre-authorization,'” she says. “It’s not just like an overnight process. It’s like a few weeks. And by the time they mail it to me, we’re talking, you know, three weeks. That means you are doing it.”
Winston was unable to receive growth hormone for three months. Behavioral effects were particularly aggravated.
“He’s been kicked out of school once a week for the past three weeks,” Hilary says.
“He has a hard time getting through the day without having an outburst or something like that,” said his father, Jeff Hall. “They sent him home because he was having a breakdown and was tearing things off the walls.”
In the end, they bought Winston a 30-day supply of growth hormone from Mexico for $1,400 without insurance.
Although there has been some improvement, challenges still remain.
Novo Nordisk said it was “taking all possible steps” to increase supply, and that supplies were more stable than they were at the beginning of the shortage. He also said the company is working with insurance companies and specialty pharmacies to simplify the drug dispensing process.
The company said in an email to NPR on March 20 that it was temporarily discontinuing one of its pen sizes to focus on other sizes. He predicted supply issues would continue for at least several more months.
NPR asked all three major pharmacy benefit managers that handle prescription drugs for insurance companies why they require new prescriptions and prior authorizations every time a patient switches during a shortage.
Members of the Hall family pose for a photo at their home in Las Vegas: parents Hilary and Jeff, and children Winston (from left), Maggie, and Walker.
NPR’s Bridget Bennett
hide caption
toggle caption
NPR’s Bridget Bennett
Members of the Hall family pose for a photo at their home in Las Vegas: parents Hilary and Jeff, and children Winston (from left), Maggie, and Walker.
NPR’s Bridget Bennett
CVS Caremark defended its decision to maintain prior authorization for growth hormone in an emailed statement. In addition to helping reduce costs for employers sponsoring employee health plans, the statement said, the Food and Drug Administration does not consider different brand names interchangeable and patients may be unable to choose a brand due to an out-of-stock situation. He said if he switched, he would need a new prescription.
Express Scripts said it offers plan sponsors, such as employers, several options to assist patients during drug shortages in general, “including additional preferred prescription substitutions. This may include drug recommendations and, in some cases, pre-approval of alternatives to affected medicines to minimize extra steps.” Ta. For prescribers and patients. The company declined to say specifically what it is doing to address the growth hormone deficiency, but said it is in contact with the manufacturer and hopes the shortage will be resolved “in the coming weeks.” He added that
Optum Rx has made several changes to its formulation and usage management to ensure members have access to somatropin products, including adding more products. ” he said. [growth hormone] the product [the] Allow formularies and members to switch between formularies [growth hormone] Assess products and strengths without generating additional pre-approval reviews. ”
Miller, the University of Florida doctor, says that seems like some progress. As of February, no insurer had taken steps to eliminate pre-approval requirements in the event of an insurance shortage, Miller said.
