In 2020, he’d fought to get insurance to cover a lower-priced version of a drug his then-8-year-old needed. She’d been diagnosed with central precocious puberty, a rare condition marked by early onset of sexual development — often years earlier than one’s peers. as part of the Bill of the Month series.

The girl’s doctors and the Taksalis decided to put her puberty on pause with a hormone-blocking drug implant that would be placed under the skin in her arm and release a little bit of the medication each day.

Taksali, an orthopedic surgeon, learned there were two nearly identical drug products made by Endo Pharmaceuticals, both containing 50 milligrams of the hormone blocker histrelin. One cost more than eight times more than the other. He wanted to use the cheaper one, Vantas, which costs about $4,800 per implant. But his insurer would not initially cover it, instead preferring Supprelin LA, which is approved by the Food and Drug Administration to treat central precocious puberty, and costs about $43,000.

Vantas for the condition, and after much back-and-forth dialogue, Taksali finally got the insurer to cover it.

Then this summer, it was time to replace the implant.

“I thought we would just get a Vantas replacement,” Taksali said. “In my mind, I was like, ‘Well, she got it the first time, and we’ve already kind of fought the battle with the insurance company and, you know, got it approved.”

But during a virtual appointment with his daughter’s doctor, he learned they couldn’t get Vantas. No one could. There was a Vantas shortage.

Endo cited a manufacturing problem. Batches of Vantas weren’t coming out right and couldn’t be released to the public, the company’s vice president of corporate affairs, Heather Zoumas Lubeski, told NPR in an email. Vantas and Supprelin were made in the same facility, but the problem affected only Vantas, she wrote, stressing that the drugs are “not identical products.”

In August, Supprelin was doing particularly well for the company. Revenue had grown by 79% compared with the same quarter the year before. The growth was driven in part, Coleman explained, “by stronger-than-expected demand resulting from expanded patient awareness and a competitor product shortage,” he said.

What competitor product shortage? Could that be Vantas?

Asked about this, Zoumas Lubeski said Coleman wasn’t referring to Vantas. Since Vantas isn’t approved to treat central precocious puberty, it can’t technically be considered a competitor to Supprelin. Coleman was referring to the rival product Lupron Depot-Ped, not an implant, but an injection made by AbbVie, Zoumas Lubeski said.

Taksali was skeptical.

“It’s all very curious, like, huh, you know, when this particular option went away and your profits went up nearly 80% from the more expensive drug,” he said.

Then, in September,

Zoumas Lubeski said that when Endo investigated its Vantas manufacturing problem, it wasn’t able to find “a suitable corrective action that resolves the issue.”

“As a result, and after analysis of the market for the availability of alternative therapies, we made the difficult decision to discontinue the supply of this product,” she said via email. “Endo is committed to maintaining the highest quality standards for all of its products.”

Taksali said he felt resigned to giving his daughter Supprelin even before the shortage turned into a discontinuation. Ultimately, he won’t pay much more out-of-pocket, but his insurance will pay the rest. And that could raise his business’s premiums.

The FDA cannot force Endo to keep making the drug or set a lower price for the remaining one. It doesn’t have the authority. That decision lies with Endo Pharmaceuticals. A drugmaker discontinuing a product isn’t anything new, said at University of Utah Health hospitals.

“The FDA has very little leverage because there is no requirement for any company to make any drug, no matter how lifesaving,” she said. “We have a capitalist society. We have a free market. And so any company can discontinue anything … at any time for any reason.”

Still, companies are supposed to tell the FDA about potential shortages and discontinuations ahead of time so it can minimize the impact on public health. It can help a firm resolve a manufacturing issue, decide whether it’s safe to extend an expiration date or help a company making an alternative product to ramp up production.

“The FDA expects that manufacturers will notify the agency before a meaningful disruption in their own supply occurs,” FDA spokesperson Jeremy Kahn wrote in an email. “When the FDA does not receive timely, informative notifications, the agency’s ability to respond appropriately is limited.”

But the rules are somewhat flexible. A company is required to notify the FDA of an upcoming drug supply disruption six months before it affects consumers or “as soon as practicable” after that. But their true deadline is five business days after manufacturing stops, .

“They’re supposed to tell the FDA, but even if they don’t, there’s no penalty,” Fox said. “There’s no teeth in that law. … Their name can go on the FDA naughty list. That’s pretty much it.”

In rare cases, the FDA will send a noncompliance letter to the drugmaker and require it to explain itself. This has happened only . There is no such letter about Vantas, suggesting that Endo met the FDA’s requirements for notification.

caused by covid-19 in March 2020, a bipartisan group of legislators introduced the , which aimed to increase transparency around shortages. But the legislation gained no traction.

As a result of limited FDA power, the intricacies of drug shortages remain opaque, Fox said. Companies don’t have to make the reasons for shortages public. That sets the Vantas shortage and discontinuation apart from many others. The company is saying more about what happened than most do.

“Many companies will actually just put drugs on temporarily unavailable or long-term backorder, and sometimes that can last years before the company finally makes a decision” on whether to discontinue a product, she said. “It can take a long time, and so it can be frustrating to not know — or to kind of stake your hopes on a product coming back to the market once it’s been in shortage for so long.”

It’s hard to know exactly how many children will be affected by the Vantas discontinuation because data about off-label use is hard to come by.

, a professor of pediatrics at the Indiana University School of Medicine, said central precocious puberty patients weren’t her first thought when she learned of the Vantas discontinuation.

“I immediately thought about our our transgender population,” she said. “They’re the ones that are really going to suffer from this.”

No medications have been FDA-approved to treat patients with gender dysphoria, the medical term for when the sex assigned at birth doesn’t match someone’s gender identity, causing them psychological distress. As a result, any drug to stop puberty in this population would be off-label, making it difficult for families to get health insurance coverage. Vantas had been a lower-cost option.

The number of transgender patients receiving histrelin implants rose significantly from 2004 to 2016, according to a study published in the .

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The staffers wear surgical masks while preparing liquid medications injected into patients’ veins to avoid breathing any droplets of saliva into the formulas, a crucial step in ensuring the medication remains sterile. Pharmacists are also in need of N95 masks to protect them as they counsel patients at hospitals — but tend to be behind front-line medical providers in line for protective gear.

The American Society of Health-System Pharmacists surveyed about 400 members about the shortages.

“I can tell you we had some very concerned members who indicated that they’re in danger of running out,” says Michael Ganio, a pharmacist and director of pharmacy practice and quality with the pharmacists’ group. “Over half said their institution has implemented a conservation plan. It’s something that’s very concerning.”

Medications that require sterile preparation include those needed for treating COVID-19 patients, such as medications to calm, sedate or paralyze patients on a mechanical ventilator. Other such medications could supply IV nutrition or boost the blood pressure of patients who develop sepsis or shock.

Geriatric and pediatric patients are also frequent recipients of sterile compounded medications because they need doses tailored to their weight or have age-related health problems that require specially made medicine they can tolerate.

The survey of hospital pharmacists, , found that 15% of them have already seen a “major or moderate” disruption in surgical mask supplies. That meant they went without masks or used alternatives with “mixed or poor” results.

Nearly 20% of them reported that mask prices were marked up compared with December 2019. And 70% of pharmacists said their organizations had already implemented plans to conserve masks.

To be sure, these conservation efforts are more optimal for pharmacists, who use masks to preserve a sterile environment, than they are for front-line COVID-19 clinicians working in a contaminated environment.

University of Utah Health Hospitals are still receiving masks. But pharmacists are reusing masks for sterile drug preparation to conserve them for other staff members and patients who need them during the outbreak, said Erin Fox, senior director of drug information and support services at the University of Utah Health Hospitals.

“That will allow more PPE [personal protective equipment] to be available for front-line emergency department folks that need it way more than we do,” she said, adding that there’s guidance on how to safely reuse masks.

A tornado that cut through Tennessee this month is making things even more complicated in the state, said Mark Sullivan, the executive director of pharmacy operations for Vanderbilt University Hospital and Clinics in Nashville. That’s because it damaged a warehouse that held hospital supplies.

“We are able to get masks,” he said. “Given the tornado and coronavirus situation, they are obviously in short supply in our area.”

Vanderbilt University Hospital and Clinics are also following guidelines for conserving masks and other personal protective equipment, like gowns and gloves, as demand has spiked, Sullivan said.

“It’s just a tough situation we’re all in, trying to make sure front-line folks have what they all need,” he said. “And behind the scenes, we’re just trying to make sure we have what we need to make safe products for patients.”

Before coronavirus became a reality, pharmacists at NYU Langone Health used to change masks and gowns when they went out on break. Now, if that gear isn’t soiled, they hang it up in a clean room and reuse it, said Arash Dabestani, the hospital’s senior director of pharmacy. His team is also keeping all personal protective equipment in an electronically locked cabinet to control use.

For weeks, hospitals have been getting fewer masks than they ask for from their suppliers. Health care facilities were getting only 44% of the N95 masks and 82% of the surgical masks they ordered, according to a survey released March 2 by Premier, a group-purchasing organization that procures supplies for 4,000 U.S. hospitals and health systems.

Most of the masks sitting in hospitals are redirected to front-line staff who care for patients, said Soumi Saha, a pharmacist who is senior director of advocacy for Premier Inc.

Saha said many state laws require pharmacists to wear masks when mixing sterile compounds. Her fear, she said, is that if the mask shortage is dire enough, hospitals will move to an unregulated way to get those crucial medications to patients: bedside compounding.

That means that clinicians such as nurses would mix the medications right in the patient’s room and put them straight into an IV, she said. She worries such a sudden shift means “we could start seeing a surge in unfortunate patient medication errors and patient harm.”

Premier has asked the federal government to waive the state requirements on pharmacists wearing medical masks to mix compounds or allow them to use industrial masks or expired ones, Saha said.

For now, the choice is up to individual states, said Carmen Catizone, executive director of the National Association of Boards of Pharmacy. He said the national standards-setting organization that advises state boards, called USP, has urged states to make their own risk assessments when weighing whether to waive rules.

So far, , and have made moves to relax the rules for pharmacists’ personal protective equipment.

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Taksali and his wife, Sara, realized their daughter had grown 7 inches in two years and was showing signs of puberty. They took her to the doctor, who referred her to a pediatric endocrinologist for a work-up.

Eventually, their daughter was diagnosed with central precocious puberty. It’s a rare condition that meant she would go through sexual development years earlier than her peers and would likely stop growing prematurely, too.

Adopted two years ago from India, she’s a bright, avid reader who loves to do kettlebell workouts with her dad and Zumba with her mom. Still, moving across the world and learning a new language is no easy feat.

“Having one more thing for her to deal with … where there might be maybe some negative attention drawn to her changing body,” Taksali said. “That was one of my big concerns.”

On the advice of their daughter’s doctors, the Taksalis decided to put her early puberty on hold. The recommended treatment is a product commonly known as a hormone blocker. Implanted beneath the skin in her arm, it releases a small dose of a drug each day that increases the body’s production of some hormones while decreasing others. The result is the child’s progression toward adulthood slows.

The doctors told them there were two nearly identical drug implants — each containing 50 milligrams of histrelin acetate — made by the same company, Endo Pharmaceuticals, an American drugmaker domiciled in Ireland. But one was considerably cheaper.

Taksali wanted his daughter to get the less expensive option, but his insurer said it would cover only the more expensive option. Resigned, he asked the hospital how much it would charge for the expensive drug he had been hoping to avoid.

Then the estimated bill came.

The Patient: Sudeep Taksali’s daughter, 8. She is insured through her father’s high-deductible UnitedHealthcare plan.

Total Estimated Bill: The hospital told Taksali the insurer wouldn’t cover the cheaper version of the drug, Vantas. After that, he spent hours trying to get an estimated bill ahead of the scheduled implantation. Supprelin LA would cost around $95,000 plus the cost of implantation, the hospital’s billing department told him. Under his health plan, he has a $5,000 deductible and 20% coinsurance obligation, so he was worried how much he might owe.

Service Provider: OHSU Hospital in Portland, Oregon, part of Oregon Health & Science University.

Medical Procedure: Implantation of a drug-delivery device containing 50 mg of histrelin acetate, to stave off early puberty.

What Gives: Supprelin LA was approved by the Food and Drug Administration in 2007 for central precocious puberty and has a list price of $37,300. Vantas was approved by the FDA in 2004 for late-stage prostate cancer and has a list price of $4,400.

The main difference between the two medicines is that Supprelin LA releases 65 micrograms of the drug a day, and Vantas releases 50 micrograms a day. Each implant lasts about a year.

The 15-microgram difference in daily dose with Vantas is less than the weight of an eyelash, and the doctors who recommended the treatment said it has the same effectiveness for children with central precocious puberty.

The much higher price for the children’s version of the drug grated on Taksali. “From a parent standpoint, as a physician, as a consumer, it feels abusive,” he said. “There’s sort of a predation on parents who have that sense of vulnerability, who will do anything within their means to help their children.”

Drugmakers can use the same chemical compound to create different branded drugs with different disease targets ― and apply for FDA approval for each. FDA spokesperson Brittney Manchester said by email, “Generally, it is the sponsor’s decision.” Endo makes both Supprelin LA and Vantas.

Indeed, other drugmakers have used the maneuver: Pfizer makes two versions of : Viagra for erectile dysfunction and Revatio for pulmonary arterial hypertension.

When we asked Endo Pharmaceuticals why Supprelin LA and Vantas had such different price tags, the company said the implants aren’t identical and treat very different conditions. It didn’t respond to questions about why that meant the prices should be different and whether it was somehow more expensive to manufacture one versus the other.

Resolution: Taksali spent more than a month trying to make sure his daughter could use the cheaper drug and, finally, the week his daughter was scheduled to have the procedure, it was approved. The hospital submitted the request again and UnitedHealthcare said it would cover it.

“Our coverage policies are aligned with FDA regulations and Vantas is not FDA approved to treat central precocious puberty,” UnitedHealthcare spokesperson Tracey Lempner said in an email. “In this specific case, when the provider expressed concern over the cost of Supprelin LA, we worked with them to allow for coverage of Vantas.”

Taksali’s daughter got the Vantas implant in late January.

When he got a breakdown of charges afterward, it listed $608 for the implantation and $12,598.47 for Vantas — about three times its list price. (Hospitals add markups to the list prices.) Still, that’s far less than the $95,000 the Supprelin LA bill would have been.

According to his explanation of benefits, after insurance, Taksali will owe $4,698.45 ― most of his high deductible. Because it is early in the year, the family had not yet spent any of its 2020 deductible.

Taksali said he fought for the lower cost drug on principle.

“Even if it is the insurance company’s money, it’s still somebody’s money,” he said. “We are still contributing to those premium dollars.”

The Takeaway: If you need an expensive drug, the first thing you should do is ask your doctor if there are cheaper alternatives. Often different formulations of the same chemical compound carry vastly different prices. In this family’s case, the version to treat prostate cancer patients was far cheaper than the pediatric version for a hormone imbalance.

More commonly, the different formulations relate to different dosages ― two 250 mg tablets may be cheaper than a 500 mg pill. Likewise, a pill you have to take three times a day may be far less expensive than the once-a-day extended-release version.

When a coverage denial leads to costly care, patients can ally with their health care providers or employers to appeal, though it can be time-consuming. Self-insured employers, in particular, won’t want to waste health care dollars either. For Taksali, using social media to direct-message UnitedHealthcare garnered prompt responses and some answers.

If there aren’t other options, drug manufacturers often offer coupons to help patients with their copays. You can find some using GoodRx or by visiting the drugmaker’s website directly.

KHN senior correspondent JoNel Aleccia contributed to this report.

Bill of the Month is a crowdsourced investigation by Kaiser Health News and that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

Ñî¹óåú´«Ã½Ò•îl Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about .

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This story can be republished for free (details).