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Patients want to keep Levemir insulin on market in U.S.

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Novo Nordisk: other long-acting insulins are safe

alternatives

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Company under scrutiny in Congress over high price of

Wegovy

By Maggie Fick and Ahmed Aboulenein

LONDON/WASHINGTON, July 30 (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 ( LLY ) 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 $300 billion since it launched anti-obesity injection Wegovy

three years ago, to $486 billion.

In addition to diminished insurance coverage, a Novo

spokesperson cited global manufacturing constraints 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

U.S. 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."