Senators Reverend Warnock, Shaheen Demand Answers from Novo Nordisk for Breaking Promise to People with Diabetes

The Senators demanded answers from Novo Nordisk on why the company discontinued the production of Levemir after taking a public relations victory lap for lowering the cost of Levemir and other insulin products

After announcing the discontinuation of Levemir, Novo Nordisk does not plan to offer a price discount on any alternative form of long-acting insulin, the most prescribed and common form of insulin

Senator Reverend Warnock has championed access to affordable insulin, capping the cost of insulin at $35 a month for seniors on Medicare and leading the charge to cap insulin at $35 for everyone

Senator Reverend Warnock:"Novo Nordisk's decision to discontinue their only affordable long-acting insulin before the price reduction took effect makes clear why Congress needs to cap insulin at $35 for everyone"

Washington, D.C. - Today, U.S. Senators Reverend Raphael Warnock (D-GA), Jeanne Shaheen (D-NH), and Elizabeth Warren (D-MA) demanded answers from Novo Nordisk on why the company discontinued the production of Levemir after taking a public relations victory lap for lowering the cost of Levemir and other insulin products. After announcing the discontinuation of Levemir, Novo Nordisk does not plan to offer a price discount on any alternative form of long-acting insulin, the most prescribed and common form of insulin. Notably, Novo Nordisk discontinued Levemir before the announced price reduction took effect. The manufacturer's public relations stunt came shortly after Senator Warnock exerted public pressure on the insulin manufacturer to cap out-of-pocket costs of their insulin products at $35 a month or less. The Senators pushed Novo Nordisk on how the company plans to ensure patients have access to affordable medication.

"Novo Nordisk's decision to discontinue their only affordable long-acting insulin before the price reduction took effect makes clear why Congress needs to cap insulin at $35 for everyone," said Senator Reverend Warnock."Insulin manufacturershave shown us for years that they care more about healthy profits than healthy people. I look forward to hearing how Novo Nordisk will make this right for diabetics in Georgia and across the country."

"Spending on insulin has tripled in the last ten years, and 17 percent of patients report rationing their insulin due to cost," wrote the Senators to Novo Nordisk. "We are alarmed by Novo Nordisk's decision to discontinue Levemir before allowing the price reduction to go into effect, and are concerned that Novo Nordisk failed to take into consideration patient access to affordable, long-acting insulin substitutes prior to the discontinuation."

Senator Warnock has championed affordable access to insulin since coming to the Senate. In February 2022, the Senator introduced the Affordable Insulin Now Act of 2022, which would cap the out-of-pocket cost of insulin at $35 for insulin users on private insurance and Medicare plans. The Senator successfully built critical support for the legislation, including garnering co-sponsorships from a majority of Senate Democrats as well as securing the bill's bipartisan passage through the House of Representatives. Additionally, the Senator secured major endorsements for his legislation from important health care and diabetes advocacy organizations, including the American Diabetes Association. Later that year, Senator Warnock successfully secured a provision of his legislation-a $35 out-of-pocket cost cap for Medicare recipients-in the Inflation Reduction Act, which was signed into law in August 2022. In spring 2023, Senator Warnock joined Senator Kennedy (R-LA) to reintroduce legislation to cap insulin at $35 for privately insured and uninsured insulin users. Thanks to the Senator's leadership, Senators Katie Britt (R-AL), Tommy Tuberville (R-AL), Mike Braun (R-IN), JD Vance (R-OH), Josh Hawley (R-MO), John Fetterman (D-PA), Gary Peters (D-MI), Jacky Rosen (D-NV), Bob Casey (D-PA), and Elizabeth Warren (D-MA) joined onto the legislation. In July 2023, Senator Warnock joined Senators Warren and Blumenthal (D-CT) to release a new investigative report highlighting how, in spite of recent efforts by drug manufacturers and insurers to reduce insulin costs, many insulin users still don't have affordable access to the life-saving drug.

In November 2023, the Senator released a new white paper illustrating the need for a federal law to lower high insulin costs. The new report analyzes county-level data across the country to examine counties with both high rates of uninsured people and high rates of diabetes-which the Senator has termed "Insulin Deserts." The report finds that 813 counties-just over a quarter of the nation's counties-are Insulin Deserts, and most of these counties are concentrated in the South and especially the Southeast, exacerbating poor health outcomes across the region. This white paper is the first published report that analyzes both counties with high rates of uninsured people and high rates of diabetes, as well as why Americans in these communities remain vulnerable despite state and federal progress on reducing the cost of insulin. Click HERE for a full timeline of the Senator's insulin leadership.

Full text of the letter is availablehere and below:

Mr. Jørgensen and Mr. Langa,

We write to you today to request more information on your decision to discontinue production of Levemir (insulin detemir), one of only three basal (long-acting) insulins on the market.

As you know, more than 7 million patients in the United States - including all patients living with Type 1 and many with Type 2 diabetes, as well as gestational diabetes - rely on a steady supply of insulin to survive. Long-acting insulins are the most prescribed and commonly used insulin, accounting for nearly two-thirds of all insulin treatment visits. Long-acting insulins are the fastest growing market segment and remain popular with patients for their ability to lengthen the time between injections while maintaining baseline blood glucose levels. Of the long-acting insulins, Levemir has the shortest duration and is the only insulin FDA-approved for pregnancy.

On March 14, 2023, Novo Nordisk announced that the U.S. list prices of several insulin products, including Levemir, would be lowered starting on January 1, 2024. Levemir is the only branded, long-acting insulin product for which Novo Nordisk announced a list price reduction. On November 8, 2023, before its 65 percent price cut had taken effect, Novo Nordisk announced that Levemir would be discontinued, with supply disruptions beginning in mid-January 2024 and formal discontinuation of the Levemir FlexPen vial on December 31, 2024. The discontinuation notice cited supply chain constraints, formulary placement issues and confidence in the availability of alternative treatments as reasons for the decision.

We have vigorously advocated for universal access to affordable insulin products. Unfortunately, that goal remains out of reach for too many Americans, in particular for in-demand, long-acting insulins with proven outcomes. Spending on insulin has tripled in the last ten years, and 17 percent of patients report rationing their insulin due to cost.6,7 Furthermore, access to affordable, in-demand biosimilar insulins will be further restricted by Novo Nordisk's decision to discontinue Levemir, as discontinuation creates significant barriers to demonstrating biosimilarity without a sample to reference.

With this in mind, we are alarmed by Novo Nordisk's decision to discontinue Levemir before allowing the price reduction to go into effect, and are concerned that Novo Nordisk failed to take into consideration patient access to affordable, long-acting insulin substitutes prior to the discontinuation. Given the importance of Levemir's availability to patients across the U.S. and to better understand the impact of this decision on patients, we ask that you respond to the following questions before May 1, 2024:

1. Please detail issues related to formulary placement for Levemir, as well as any steps Congress can take to alleviate such issues in the future.
2. Please detail ongoing supply chain constraints that led to the discontinuation of Levemir, as well as any steps Congress can take to alleviate such issues in the future.
3. Please detail steps Novo Nordisk has taken to ensure that patients currently prescribed Levemir, including those with preferred formulary placement of Levemir, have access to similar long-acting insulin products without gaps in coverage and at similar cost-sharing.
4. Does Novo Nordisk intend to decrease the price on any other long-acting insulin product, such as Tresiba, similar to the price decrease of Levemir in March 2023?
5. Will Novo Nordisk commit to produce Levemir until a biosimilar product becomes available?
6. Has Novo Nordisk been contacted by any manufacturers expressing interest in producing a biosimilar for Levemir?
   1. If yes, will Novo Nordisk help facilitate the introduction of a Levemir biosimilar into the market?
   2. If no, will Novo Nordisk commit to making the relevant patents, technologies, and manufacturing capabilities available to expedite the introduction of a Levemir biosimilar?

Thank you for your attention to this matter. We look forward to your timely response.

Sincerely,

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