By Maggie Fick and Ahmed Aboulenein
LONDON/WASHINGTON (Reuters) - Novo Nordisk's decision to stop selling its long-acting insulin Levemir in the United States has left some diabetes patients struggling to switch treatments, patients and doctors in a dozen U.S. states told Reuters.
The Danish drugmaker said in November it would halt U.S. sales of Levemir by the end of 2024. Many health plans no longer cover the drug, which went off patent in 2019, and there are other options for patients on the market, Novo said.
Several people with type 1 diabetes as well as parents of pediatric patients told Reuters they are stockpiling the remaining supply of Levemir and using vials they have on hand beyond their expiration date, while hoping a nascent lobbying effort will keep the drug on the market.
They say Levemir is better suited for youth and others with an active lifestyle. Doses can be adjusted more frequently than with other long-acting, or basal, insulins.
Some described dangerously low blood sugar levels, known as hypoglycemia, or rapid fluctuations, when they used other long-acting insulins Novo says are safe alternatives, including its own Tresiba and products sold by Eli Lilly and Sanofi.
Jaime Losinki's teenaged son was diagnosed with type 1 diabetes seven years ago and prescribed Sanofi's Lantus. He suffered repeated bouts of very low blood glucose that "came out of nowhere." The problem stopped when he switched to Levemir, Losinki said.
"I feel like type 1 diabetics deserve the right to have normal blood sugars just as much as anyone else does," she said. "And if there's a product out there that can help that happen, it shouldn't be taken away from them."
Novo's decision comes as it ramps up production of its fast-selling weight-loss treatments. Its market value has risen by $380 billion since it launched anti-obesity injection Wegovy three years ago, to $572 billion.
In an emailed statement to Reuters, a Novo spokesperson cited global manufacturing constraints in addition to diminished insurance coverage among the reasons behind the decision to discontinue Levemir in the United States.
The Wegovy windfall has also drawn scrutiny from the U.S. Congress over the drug's high list price, at over $1,349 per month. Novo CEO Lars Fruergaard Jorgensen will testify before lawmakers in early September.
Diabetes patient advocates fear Novo is pulling back on manufacturing of less profitable insulins to meet the unprecedented demand for Wegovy. The company denies this.
The Levemir decision "makes me and my patients nervous about being at the mercy of the companies just deciding all of a sudden where to put their resources," said Dr. Kasia Lipska, an endocrinologist and professor at Yale University's School of Medicine.
LOBBYING EFFORT
Advocacy groups estimate that over 1 million people in the United States were using Levemir in 2021. It's not clear how far that figure has dropped since then due to reduced insurance access.
Novo reported U.S. Levemir sales of 1.3 billion Danish crowns ($185 million) in 2023, less than 10% of sales in 2016, when Novo launched the higher-priced Tresiba as a successor product.
While some people with diabetes are able to switch relatively easily from one insulin regimen to another, others are extremely sensitive to any change, said Lipska.
"None of the products (Novo Nordisk) cited are exactly interchangeable," said Laura Marston, co-founder of advocacy group The Insulin Initiative. "So for a diabetic that means taking risk."
Marston's organization is primarily focused on lobbying to keep insulin prices affordable.
A new group of parents and patients, called the Alliance to Protect Insulin Choice, have taken their Levemir concern to Capitol Hill. Their petition urging Novo Nordisk to continue making Levemir has garnered over 4,000 signatures, said Alison Smart, one of the parents who set up the group.
Three Democratic U.S. Senators called on Novo to continue manufacturing Levemir until other drugmakers can make a cheaper, biosimilar version, according to a letter they sent to the company in April and to advocates in touch with their offices.
The lawmakers are also asking Novo to hasten a close alternative to market by either helping facilitate introduction of a biosimilar product or making the patents available so others might do so. Senate aides met with Novo representatives earlier this month to discuss Levemir, Reuters reported.
"Levemir has been off patent for a number of years and another manufacturer could produce the drug should they choose to," the spokesperson said.
One father said his seven-year-old son had switched to Levemir after developing anxiety about wearing an insulin pump, which delivers appropriate doses of insulin under the skin. They can be hard for children and some adults to use.
"It was making his life as a diabetic even tougher than it already was," said Kirill Zenchenko from Massachusetts.
Zenchenko is among the parents stockpiling Levemir, trying to put off what he fears would be a difficult transition for his son back to the pump or to Lantus.
"It's tough to explain to him that 'Well, the company is not making this anymore, so that's why you have to go on the pump,'" he said.
"Novo Nordisk should hear the perspective of kids -- and adults too obviously -- of having to go through this process of not having a good choice."
(Reporting by Maggie Fick in London and Ahmed Aboulenein in Washington; Editing by Michele Gershberg, Bill Berkrot and Emelia Sithole-Matarise)
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