Discontinuation of Levemir and its Ramifications, by Alison Smart
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Discontinuation of Levemir and its Ramifications
I met Roxana at the LowCarb USA Symposium for Metabolic Health in Boca, Florida a few weeks ago. It was a fabulous conference! A full two days was devoted to type 1 diabetes. We were grateful to the organizers of the event for inviting excellent speakers to educate attendees about the management of type 1 diabetes.
I want to share my concerns about an issue regarding Levemir (detemir) insulin, a basal insulin that many with type 1 diabetes use. Levemir is also used for type 2 diabetes, but for the purpose of this blog, I will discuss it in the context of type 1 diabetes.
In March 2023 Novo Nordisk announced they would decrease the price of Levemir by 65%. Then just eight months later, in November, Novo Nordisk announced they would discontinue Levemir in the US by the end of 2024. Prefilled injection pens would be discontinued in April, vials would be discontinued in December, with supply disruptions expected by mid-January 2024. That means they essentially gave two months' notice to some people.
Levemir is an important basal insulin in the the treatment of type 1 diabetes. The only realistic alternatives are an insulin pump, or two remaining basal insulin types: glargine (Lantus and biosimilars), and degludec (Tresiba).
An insulin pump works well for many with type 1 diabetes, but some groups of people do not desire to use a pump. They include many athletes, those with adhesive allergies, and those who may not be able to afford an insulin pump.
Glargine insulins are in an acidic solution, and many users report that they sting and burn upon injection. There is also a real possibility of experiencing a "Lantus Low" when using glargine insulin. The Lantus monograph, on page 45, describes a Lantus Low by stating, "Hypoglycemia can result from injection directly into a blood vessel and if not recognized or treated may be followed by hyperglycemia since there was not Lantus deposition for long-term absorption." This does not happen in the same way with the other two basal insulins.
Tresiba lasts much longer than Levemir. When making a change in the amount of Tresiba, a change is not seen for three days. Teenagers have basal needs that change much more frequently than this. If a teen needs more Tresiba than the amount injected, they would then need to take a shot of fast-acting insulin every few hours for the next few days if they wanted to maintain good blood glucose levels until the level was correct. Conversely, if too much Tresiba were given, the individual would then need to eat sugar/carbs/glucose in some capacity frequently for three days to stay at good levels.
With Levemir, if a basal level is not correct one day, the change can take place by the next day, as Levemir lasts much shorter than Tresiba. This is an advantage in those whose basal levels change frequently, such as teenagers, athletes, and menstruating women.
Additionally, some experience side effects when using Tresiba that may include nosebleeds, nasopharyngitis, or other upper respiratory issues.
A few other facts: Levemir is on the World Health Organization's list of essential medicines for 2023. It is the only basal insulin that can be diluted. That is important for infants, toddlers, and many who are newly diagnosed. It is the only basal insulin with FDA Pregnancy Category B classification, indicating that it does not pose a higher risk of harm for the unborn when used by pregnant women with diabetes. It is ideal for the insulin-sensitive. It is an important alternative when people experience allergic reactions or side effects from the other two basal insulins.
On a personal note, I am the parent of a 15 year-old daughter who has had type 1 diabetes for two years. She is a tennis player who regularly competes in tournaments. She uses Levemir with great results. We love the flexibility that Levemir provides. There will be others like her in the future; teens diagnosed with type 1 diabetes who want to compete like other kids their age. This will be more difficult if Levemir is not available.
I am heading to Washington DC soon with a small group of people to meet with lawmakers, and ask them to pressure Novo Nordisk to continue to produce Levemir until a biosimilar can be created. Initial reports are that having a biosimilar approved by the FDA will take four to five years and $80 million. We hope Levemir will continue to be available, without any lag time.
Please reach out if you would like to help with this important effort: insulinoptions@gmail.com.
Written by Alison Smart
North Salt Lake, UT
Published January 27th, 2023
