It’s In the News! A look at the top diabetes stories and headlines happening now. Top stories this week: a new study shows that drugs like Ozempic can be produced for just a few dollars, we upate the insulin vial shortage Lilly announced, a new pump has been FDA cleared, a genetically modified cow can product human insulin, and more!

Transcript and links below

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Episode transcription and links:

Hello and welcome to Diabetes Connections In the News! I’m Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now.

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In the news is brought to you by Edgepark simplify your diabetes journey with Edgepark

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Our top stories this week… all about cost.

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The blockbuster diabetes drug Ozempic could be manufactured for less than $5 a month, even as Novo Nordisk  charges close to $1,000 per month for the injection in the U.S. before insurance, a study released Wednesday suggests.

The study, from researchers at Yale University, King’s College Hospital in London and the nonprofit Doctors Without Borders, raises more questions about the hefty price tag of the top-selling diabetes treatment and similar drugs for weight loss, which are all part of a new class of treatments called GLP-1s.

The study also comes after years of political pressure on Novo Nordisk and other drugmakers to slash high costs of diabetes care, especially insulin.

Researchers found that a month’s supply of the treatment could be manufactured for an estimated 89 cents to $4.73. They evaluated manufacturing costs for the weekly injection along with a profit margin with an allowance for tax to produce those estimates, which they call “cost-based prices.”

 

Novo Nordisk’s list price for a monthly package of Ozempic is $935.77 before insurance and other rebates.

In a statement on Wednesday, Novo Nordisk declined to provide production costs for Ozempic and its weight loss drug counterpart Wegovy. But the Danish drugmaker noted that it spent almost $5 billion on research and development last year, and will spend more than $6 billion on a recent deal to boost manufacturing to meet demand for GLP-1s.

Separate research from the University of Liverpool and other researchers has found that Wegovy could be produced for $40 a month.

 

https://www.cnbc.com/2024/03/27/novo-nordisk-ozempic-can-be-made-for-less-than-5-a-month-study.html

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Update on the product shortage from Eli Lilly – I’m being careful not to say insulin shortage, because it looks like this is actually a vial shortage.

“The 10 mL [millilter] vials of Humalog® and Insulin Lispro Injection are or will be temporarily out of stock at wholesalers and some pharmacies through the beginning of April,” Lilly said in a recent statement.

The company said it is continuing to make the 10 mL vials, and “will ship them as soon as we can.” However, in the meantime patients with diabetes may need to consult with their doctors “to discuss switching to the same insulin in a prefilled pen or other insulin treatment options,” Lilly said.

Lilly said it is offering customers without insurance a coupon program offering insulin for $35.

 

Lilly spokesman Tarsis Lopez told CNN that the “dynamic nature of insulin supply and demand, coupled with a brief delay in manufacturing, led to the temporary supply constrain.

Editorial comment: this sounds like complete BS. I’ve reached out to Lilly and – if you’re listening – we’d love to have you on the show.

Lilly took in 2 point 1 billion dollars for the fourth quarter of 2023  – that’s three months NET income! So buy some vials and fix this.

https://www.usnews.com/news/health-news/articles/2024-03-25/eli-lilly-warns-that-2-insulin-products-will-be-in-short-supply

 

https://www.pharmaceutical-technology.com/news/eli-lilly-q4-2023-income/#:~:text=The%20company’s%20revenue%20in%20Q4,quarter%20of%20the%20previous%20year.&text=Lilly’s%20earnings%20per%20share%20grew,to%20%242.42%2C%20up%2013%25.

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Medicare wil now cover certain weight loss drugs but.. not for weight loss.. only when they are prescribed to prevent heart attacks and strokes. This includes Novo Nordisk’s Wegovy, a medication that’s surged in popularity due to its remarkable effects for treating obesity and excess weight in people without diabetes. Last month, the FDA expanded Wegovy’s uses, making it the first medication to reduce the risk of heart attacks, strokes, and cardiovascular death in people with heart disease and obesity.

Since 2003, Medicare has been banned from covering weight loss medications, because they are considered cosmetic. This, even though many studies have shown people living with obesity and excess weight are at a greater risk for other health conditions including type 2 diabetes, heart disease, certain cancers, and more.

Making things even more difficult, Medicare hasn’t been allowed to negotiate medication prices directly with drug companies – until recently. Thanks to the Inflation Reduction Act passed in 2022, Medicare has entered the first cycle of price negotiations for 10 drugs, including ones approved for diabetes, heart failure, and kidney disease.

Does Medicaid cover weight loss drugs?

Right now, Medicaid offers more flexibility than Medicare on coverage for weight loss medications – depending on what state you live in. As of 2023, the states that offer Wegovy and another weight loss drug Saxenda (liraglutide) without restrictions include:

California Delaware Minnesota Rhode Island Virginia

Five other states – Georgia, Michigan, New Hampshire, Pennsylvania, and Wisconsin – also offer coverage of Wegovy or Saxenda but with restrictions.

This is also a possible precedent for private insurers to follow suit.

https://diatribe.org/medicare-can-now-cover-wegovy-%E2%80%93-not-weight-loss

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A new study in the peer-reviewed journal Diabetes Technology & Therapeutics (DTT) evaluated the use of tirzepatide in overweight/obese adults with type 1 diabetes.

 

Tirzepatide is approved for managing type 2 diabetes. It improves glucose control, facilitates weight loss, and improves cardiovascular disease outcomes.

 

Satish Garg, MD, from the University of Colorado Denver, and coauthors, compared a group of adults with type 1 diabetes who were prescribed tirzepatide (off-label) to a control group of adults with type 1 diabetes who were not using any weight-loss medication. The investigators reported significantly larger declines in body mass index (BMI) and weight in the treated group compared to controls. HbA1c decreased in the treated group as early as three months and was sustained through a one-year follow-up. Insulin dose decreased at 3 months in the treated group and throughout the study period.

 

“We conclude that tirzepatide facilitated an average 18.5% weight loss (>46 pounds) and improved glucose control in patients with T1D at one year,” stated the investigators.

 

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“Most of the patients with diabetes, both type 1 diabetes (T1D) and T2D are either overweight or obese in the United States and Western Europe,” state Satish Garg, MD, and coauthors of an accompanying Editorial. The newer therapies for diabetes, which are known to not only improve glucose control but also cause significant weight loss and improve cardiovascular disease and diabetic kidney disease are currently not approved in the U.S. for use in type 1 diabetes. “Using GLP analogs in patients with T1D poses many challenges, but with close follow-up both patients and the healthcare provider may see many benefits such as significant weight loss and reduction of insulin dose, increased time-in-range on continuous glucose monitoring, and improve HbA1c levels,” state the authors. Long -term side-effects like gastroparesis, GERD, Cholelithiasis etc. from use of GLP analogs in patients with diabetes are not known. The authors recommend proper randomized control trials especially in patients with T1D.

 

Source:

https://www.news-medical.net/news/20240322/Study-evaluates-the-use-of-tirzepatide-in-overweightobese-adults-with-type-1-diabetes.aspx

 

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State caps on insulin costs lowered privately insured patients’ out-of-pocket spending, but they didn’t appear to increase insulin use.

State insulin caps, which range from $25 to $100 for a month’s supply, were associated with 17.4% relative decrease in consumer out-of-pocket costs,

The savings were over twice as large (40%) among patients using health savings accounts, while patients in states with caps between $25 and $30 were most likely to see a drop in costs.

However, insulin use remained constant for nearly all populations, though it increased for lower-income patients with HSAs in states with $25-$30 caps.

Previous studies found Medicare enrollees’ prescription fills rose after Medicare implemented a new $35 cap on monthly insulin costs.

Not sure why its surprising that those with the lowest income and on government healthcare – Medicare – used more insulin when the price went down. Especially because Researchers said those with private insurance are on average healthier and less likely to need insulin, and they might be less affected by caps because they have more resources to afford the medication.

https://www.axios.com/2024/03/26/insulin-costs-insurance

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New FDA Clearance for the Twiist Automated Insulin Delivery System. This is hardware from DEKA Research, and will be brought to market by Sequel Med Tech. Software is Tidepool Loop.

DEKA is the company behind the Segway and a lot of other tech.. it’s founder Dean Kamen invented the first wearable insulin pump decades ago.

The Twiist looks like a small, flat disc. It has a tube. The company says it’s the first drug delivery system that measures both insulin volume and flow with each micro-dose, according to a company press release.1 The system is cleared for use in individuals aged 6 years and older with type 1 diabetes.

I’m set to talk to Sequel Med Tech in April..

https://www.drugtopics.com/view/fda-grants-clearance-to-twiist-automated-insulin-delivery-system-for-t1d

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Use of continuous glucose monitoring by patients with type 1 diabetes was associated with lower odds of developing diabetic retinopathy, according to a study recently published in the JAMA Network Open.

Diabetic retinopathy affects the blood vessels in the retina and can cause vision loss and blindness.

One study, published in January 2024, found that 49.8% people with type 1 diabetes in the sample of those with commercial insurance used the devices from 2016 to 2019, up from 20.1% from 2010 to 2013.

Researchers found that use of continuous glucose monitoring was associated with lower the risk of developing diabetic retinopathy, as well as lowering the risk of the disease progressing. They suggested that the use of such technology reduces variability in glucose levels.

One limitation that researchers identified was that they did not assess people with Medicare or Medicaid coverage and this could be an area for future examination.

https://www.managedhealthcareexecutive.com/view/continuous-glucose-monitoring-lowers-risk-of-diabetic-retinopathy

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A new analysis pours cold water on the effectiveness of widely used digital diabetes management solutions, stirring up discussion about how best to evaluate the growing market of digital health tools.

Before we go further – and this was buried in most of the article I saw about this – they’re referring not to AID systems or CGM but to eight widely used digital health tools that support people with Type 2 diabetes from DarioHealth, Glooko, Omada, Perry Health, Teladoc (Livongo), Verily (Onduo), Vida Health and Virta Health.

The blistering report, released by the Peterson Health Technology Institute (PHTI), concluded that diabetes monitoring apps “do not deliver meaningful clinical benefits, and result in increased healthcare spending.”

 

It’s the organization’s first analysis since launching in July as an independent evaluator of digital health technologies. The Peterson Center on Healthcare launched the PHTI, with a commitment of $50 million, to assess the clinical benefits and economic impact of digital health solutions along with the offerings’ effects on health equity, privacy and security.

“If health plans or employers are going to be paying extra for these solutions, they have to deliver extra benefit clinically above and beyond what a patient would expect in ‘usual care,'” she said.

https://www.fiercehealthcare.com/digital-health/diabetes-management-tools-not-worth-cost-study-finds-digital-health-companies-push

 

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Is a cow going to be our rescue here? A genetically altered brown bovine cow recently made history by producing human insulin in its milk.

The results, published March 12 in Biotechnology JournalTrusted Source, indicate a potential solution for mass-produced insulin, but more research is warranted to confirm these findings. Caution around using genetically modified animals to advance human pharmacology is also needed.

Non-study author Brett M. Sansbury, PhD, principal investigator and leader of discovery research at ChristianaCare’s Gene Editing Institute, commented on the potential implications of this research to Medical News Today:

“Genetic engineering has so much potential for significant advancements in how we understand, diagnose and treat diseases. This study highlights the promise this field has in applications for improving human health. While the researchers here describe the practical challenges they experienced in this proof-of-concept study, the implications for increasing the supply of an essential drug, with the potential to make it more accessible to a wider population suffering from a very prominent disease, could be very impactful.”

https://www.medicalnewstoday.com/articles/genetically-altered-cow-produces-human-insulin

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