The drug company drops its cheaper hormone-blocking drug, keeps the more expensive one: shots

The drug company drops its cheaper hormone-blocking drug, keeps the more expensive one: shots


An active 8-year-old girl diagnosed with premature puberty was prescribed a hormone-blocking drug implant. The price of one option was thousands of dollars lower than the other.

Kristina Barker for KHN


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Kristina Barker for KHN


An active 8-year-old girl diagnosed with premature puberty was prescribed a hormone-blocking drug implant. The price of one option was thousands of dollars lower than the other.

Kristina Barker for KHN

Sudeep Taksali thought his battle over the high price of a drug was over. He was wrong.

In 2020, he had struggled to get insurance for a cheaper version of a drug that his then 8-year-old daughter needed. She had been diagnosed with a rare condition called central premature puberty, which would have resulted in sexual development years earlier than her peers. MediaFrolic and KHN wrote about Taksali and his family as part of our Bill of the Month series.

Her doctors and the Taksalis decided to break their puberty with a hormone-blocking drug implant that was placed under the skin in her arm, releasing a little of the drug every day.

Taksali, who happens to be an orthopedic surgeon, learned that there were two almost identical drugs from Endo Pharmaceuticals, both of which contained 50 milligrams of the hormone blocker histrelin. But one was more than eight times more expensive than the other.

He wanted to use the cheaper Vantas, which costs around $ 4,800. But his insurer wouldn’t initially cover it, preferring Supprelin LA, which is approved by the Food and Drug Administration for the treatment of central premature puberty and costs around $ 43,000. Vantas can be prescribed for the condition off-label, and after much back and forth, Taksali finally got the insurer to cover it.

That summer it was time to replace the implant.

“I thought we would just get a Vantas replacement,” says Taksali. “In my head I was like, ‘Well, she got it the first time, and we’ve already fought the insurance company and got it approved.”

But during a virtual appointment with his daughter’s doctor, he learned they couldn’t get Vantas. Nobody could.

There was a lack of Vantas.

Endo told MediaFrolic that there was a manufacturing issue. Batches from Vantas did not come out properly and could not be released to the public, Heather Zoumas Lubeski, the company’s vice president of corporate affairs, told MediaFrolic in an email. Vantas and Supprelin were made in the same facility, but the problem only affected Vantas, she wrote, stressing that the drugs were “not identical products”.

In August, Endo’s President and CEO Blaise Coleman told investors that Suprelin was doing particularly well for the company. Sales were up 79% compared to the same quarter of the previous year. The growth was driven in part, said Coleman, “by higher-than-expected demand resulting from increased patient awareness and product shortages from competitors,” he says.

What is the product shortage of the competition? Could that be Vantas?

When asked about this, Zoumas Lubeski says that Coleman was not referring to Vantas. Because Vantas is not approved for the treatment of central premature puberty, it cannot technically be considered a competitor to Suprelin. The competing product Coleman was referring to was Lupron Depot Ped, not an implant but an injection from AbbVie, says Zoumas Lubeski.

Taksali is skeptical.

“It’s all very weird, like, huh, you know, when that particular option was dropped and your profits from the more expensive drug went up almost 80%,” he says.

Dr. Sudeep Taksali asked why Endo Pharmaceuticals made two nearly identical drug delivery implants at very different prices. Then the company hired the cheaper one.

Kristina Barker for KHN


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Dr. Sudeep Taksali asked why Endo Pharmaceuticals made two nearly identical drug delivery implants at very different prices. Then the company hired the cheaper one.

Kristina Barker for KHN

Then, in September, Endo notified the FDA that it had permanently stopped manufacturing Vantas.

When Endo investigated its production problem at Vantas, it could not “find an appropriate corrective measure that would solve the problem,” says Zoumas Lubeski.

“As a result, and after analyzing the market for the availability of alternative therapies, we made the difficult decision to stop shipping this product,” she wrote in the email to MediaFrolic. “Endo strives to maintain the highest quality standards for all of its products.”

Taksali says he resigned himself to giving his daughter supprelin even before the shortage became a demolition. In the end, he doesn’t end up paying much more out of his own pocket, but his insurance pays the rest. And that could increase his company’s premiums.

But there’s not much the FDA can do about it. It cannot force Endo to keep making the drug or to set a lower price for the remaining drug. It does not have the authority under the laws in force.

Overall, a drug manufacturer’s discontinuation of a product is nothing new, says Erin Fox, who heads drug information and support services at the University of Utah Health’s hospitals.

Ultimately, the decision rests with Endo Pharmaceuticals.

“The FDA has very little leverage because no company is required to make a drug, no matter how life-saving it is,” she says. “We have a capitalist society. We have a free market. And so any company can stop anything … at any time and for any reason.”

Still, companies should notify the FDA in advance of potential bottlenecks and discontinuations so they can minimize the public health impact. It can help a company solve a manufacturing problem, decide whether it’s safe to extend an expiration date, or help a company making an alternative product ramp up production.

“The FDA expects manufacturers to notify the agency before there is a significant interruption to their own supply,” FDA spokesman Jeremy Kahn wrote in an email. “If the FDA does not receive timely, informative notifications, the agency’s ability to respond appropriately is limited.”

But the rules are a bit flexible. A company should notify the FDA of an impending drug supply interruption six months in advance or “as soon as possible” thereafter. But they really have up to five business days after they are discontinued, according to the FDA website.

“They’re supposed to tell the FDA, but even if they don’t, there’s no penalty,” says Fox. “This law has no teeth … your name could get on the FDA naughty list.

In rare cases, the FDA sends the drug manufacturer a non-compliance letter asking them to explain. But that has only happened five times since 2015.

There is no such letter from Vantas indicating that Endo has met FDA notification requirements.

Concerned about possible drug shortages caused by COVID-19 in March 2020, a bipartisan group of lawmakers passed the Drug Shortage Prevention Act, but it got nowhere. The aim was to increase transparency in the event of bottlenecks.

A girl, then 8 years old, reads a book after school. She recently underwent her second treatment for central premature puberty or early puberty.

Kristina Barker for KHN


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Kristina Barker for KHN


A girl, then 8 years old, reads a book after school. She recently underwent her second treatment for central premature puberty or early puberty.

Kristina Barker for KHN

Because of the limited powers of the FDA, much about drug shortages is obscure, says Fox. Companies don’t have to make the reasons for their scarcity public. This is what sets the Vantas deficiency and attitude apart from many others. The company says more about what happened than most do.

“Many companies become temporarily unavailable or reorder long-term, and sometimes it can take years for the company to make a final decision,” she says. “It can take a long time, so it can be frustrating not to know – or to place your hopes on a product coming back on the market if it’s been in short supply for so long.”

It is difficult to say exactly how many children will be affected by discontinuation of Vantas because data on off-label use is difficult to come by. Dr. Erica Eugster, a professor of pediatrics at Indiana University School of Medicine, says some medical institutions used Vantas and supprelin interchangeably for central precocious puberty and others did not.

But the condition isn’t the first thing that came to mind when Eugster found out about Vantas’s dismissal.

“I immediately thought of our transgender population,” she told MediaFrolic. “They are the ones who are going to really suffer.”

No drugs have been approved by the FDA to treat patients with gender dysphoria, which is the medical term for when a person’s gender at birth does not match their gender identity, resulting in mental illness. As a result, any drug to prevent puberty in this population would be off-label, making it very difficult for families to get health insurance. Vantas had been a cheaper option.

According to a study published in the Journal of Pediatric Endocrinology and Metabolism, the number of transpatients who received histrelin implants increased significantly between 2004 and 2016.



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Rachel Meadows

Rachel Meadows

Trending topics news writer who enjoys cooking, walking her dog and travel.

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