After she was diagnosed at age 48 with Type 1 diabetes, Stacey Silverman muddled through her days with high blood sugar, fatigue and splitting headaches.
Taking a long-acting form of insulin called Levemir, one of many types of the hormone on the market, resolved those blood sugar swings.
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Now the 55-year-old Dallas-area resident worries her health will once again be upended. Novo Nordisk, the pharmaceutical company that makes Levemir, has announced it will discontinue the drug this year. That means Silverman and tens of thousands of patients like her will have to find a replacement.
“I need this drug to live,’ said Silverman, an information technology professional. “This drug has worked very well for me since I was diagnosed.”
Diabetes patients who depend on insulin recently got a financial break when the three major insulin manufacturers enacted dramatic price cuts. Novo Nordisk announced last March it would slash the list price of Levemir by 65%. But the good news was short-lived.
The drugmaker will stop selling the injectable FlexPen version of Levemir in April and will halt sales of Levemir vials by the end of December. The company has not announced plans to discontinue the drug in other countries.
In a statement to USA TODAY last week, Novo Nordisk said it would discontinue U.S. sales of Levemir because of a combination of factors, including global manufacturing constraints and the availability of other forms of insulin. The company also cited pharmacy managers and insurers who limited access to Levemir on drug formularies, the list of drugs insurers cover for patients.
“Our top priority is always the health and safety of the patients (who) use our products,” Novo Nordisk said. “We made this decision after careful consideration and are confident that given the advanced notice, U.S. patients will have access to alternative treatments and can transition to other options.”
Novo Nordisk said patients can switch to other brands of long-acting insulins, including glargine, which is sold under the brand names Basaglar and Lantus, as well as degludec, sold under the brand Tresiba. Patients also often need to take quick-acting insulin with meals.
Mom chooses Levemir over newer drugs, pumps
Diabetes patient advocates said the discontinuation of Levemir is another example of the challenges insulin-dependent patients face.
For years, advocates have pushed for more affordable insulin. The list price for certain forms of insulin − a medication needed by everyone with Type 1 diabetes and some with Type 2 − nearly tripled from 2002 to 2013.
A 2022 study in the Annals of Internal Medicine estimated that 16.5% of adults who depended on insulin for their diabetes did not take full doses as prescribed because of the high cost.
Politicians, patient advocates and analysts ratcheted up pressure on drug manufacturers to lower insulin prices. Federal and state laws, Medicare and Medicaid policies and changing market dynamics for these older insulin drugs have also influenced price cuts.
To read more:Deciphering America’s Type 2 diabetes dilemma
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Levemir gained Food and Drug Administration approval as a treatment for diabetes in 2005. Newer, longer-acting insulins have since hit the market and even more insulin medications are being developed.
What’s more, a new class of weight loss drugs, known as GLP-1 receptors, also are proven to be effective for people with Type 2 diabetes. Small studies suggest these drugs could delay or reduce insulin use, although they aren’t useful for those with Type 1 diabetes.
Families with loved ones who use Levemir worry about losing a drug that has worked well for nearly two decades.
Salt Lake City resident Alison Smart discovered through trial and error that Levemir is the best option for her 15-year-old daughter.
The teen tried an insulin pump that delivers small amounts of medicine throughout the day. But during a tennis tournament, although exercise typically causes blood sugar levels to drop, her’s spiked. Smart didn’t know whether the pump malfunctioned or other factors led to the problem.
She ditched the pump and began using Levemir, which has helped the teen maintain consistent blood sugar levels. Fluctuations in blood sugar levels can lead to serious health problems, as well as dips in energy, headaches and other issues.
Levemir is one of three types of long-acting “basal” insulins, but it doesn’t last in the body as long as other basal versions. Lantus lasts 24 to 36 hours, and Tresiba lasts up to 42 hours.
Because Levemir metabolizes more quickly, Smart said it makes it easier to adjust dosages each night to meet her daughter’s insulin needs.
“If she’s running a little low on one night’s dose, we can change it and fix it for the next night,” Smart said.
Smart has encouraged other families to urge Novo Nordisk to reconsider their decision to halt a drug that works well.
“I feel like the focus is curing diabetes and having more technology when we just want the tools that work to stay available,” Smart said.
‘A real problem for diabetics who need it’
Jacksonville, Florida, resident Lester Hightower said Levemir has been a critically important drug for his teenage son, Andrew, who has Type 1 diabetes. He also chose Levemir over other long-acting insulins because of its faster metabolizing, making it easier to adjust for his son’s insulin needs.
Levemir has kept Andrew’s blood levels stable throughout the day and especially at night, matching the growing teenager’s needs when other hormones can counteract insulin. During the peak of his physical growth from ages 14 to 16, Andrew adjusted to take most of his dose to match his overnight needs.
When he was playing on the high school basketball team, he needed less insulin when he was running and moving on the court. Insulin lowers blood sugar levels much more rapidly after exercise.
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Andrew, now 18 and a freshman at Florida State University, has again adjusted his insulin intake based on his classes and exercise.
When Levemir is discontinued, Hightower fears that active teens who depend on the drug will struggle to find a suitable replacement.
“If Levemir goes off the market, there will be no basal insulin like it left,” Hightower said. “And that creates a real problem for diabetics who need it.”
Insulin makers replace old drugs with newer versions
Drug companies often have discontinued older versions of insulin when they develop newer versions of the medication.
A 2023 paper in the Journal of Law and the Biosciences reported 62 types of insulin have been discontinued since the medication was first discovered over a century ago. Most were obsolete animal insulins, but the paper said 16 human insulins and 13 analogs, or synthetic insulins meant to mimic the release of human insulin, also have been nixed.
These insulin versions were not discontinued because of safety concerns or ineffectiveness, but many were replaced by newer formulations or delivery methods, often at more expensive prices, the paper said.
Robin Feldman, a University of California law professor who wrote the paper, said discontinued insulin products “remove many viable products from the market, limiting treatment options for patients.
These older insulins are often replaced with newer formulations, delivery methods or technology that are more expensive.
“It’s a shell game in which the consumer always loses,” said Feldman.
Financial analysts who track Novo Nordisk said the Denmark-based company likely is focusing more on the lucrative market of GLP-1 weight-loss drugs. Novo Nordisk has recorded billions in sales from its weight-loss drug Wegovy and the diabetes drug Ozempic. Sales of these GLP-1 drugs have far outpaced Levemir’s sales.
Emily Field, an analyst with Barclays, said insulin is of “decreasing financial importance” to Novo Nordisk. She cited the difficulty of raising prices in a market saturated with competing insulin makers, including biosimilars.
Michael Nedelcovych, an analyst with Cowen, said Novo Nordisk likely chose to concentrate on marketing Tresiba, a newer insulin product. He noted the company also has a weekly insulin drug called icodec that could hit the market this year.
For Type 1 diabetes patients like Silverman, news about new drugs such as GLP-1s offer little benefit. She doesn’t need to lose weight. She just wants to continue taking the drug that works for her: Levemir.
“I’m scared to change from Levemir because it works so well for me,” she said.
Ken Alltucker is on X, formerly Twitter, at @kalltucker, or can be emailed at [email protected].
Source: https://t-tees.com
Category: WHY
