Warren, Shaheen, Warnock, Seek Answers from Novo Nordisk on Discontinuation of Levemir Insulin After Announced Price Reduction

April 17, 2024

Warren, Shaheen, Warnock, Seek Answers from Novo Nordisk on Discontinuation of Levemir Insulin After Announced Price Reduction

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."

More than 7 million patients in the United States rely on a steady supply of insulin to survive.

Text of Letter (PDF)

Washington, D.C. - U.S. Senators Elizabeth Warren (D-Mass.), Jeanne Shaheen (D-N.H.), and Reverend Raphael Warnock (D-Ga.) sent a letter to the leadership of Novo Nordisk (Novo), slamming the company for its decision to discontinue production of Levemir (detemir) insulin -one of only three long-acting insulins on the market-and asked the company to commit to continue producing Levemir until a biosimilar is made available.

On March 14, 2023, Novo Nordisk announced that the price of Levemir would be lowered by 65% starting January 1, 2024, but before the price cut could take effect, Novo announced on November 8, 2023 that Levemir would be discontinued. Supply disruptions began in mid-January 2024, with formal discontinuation of the Levemir FlexPen vial set to occur on December 31, 2024.

"Long-acting insulins are the most prescribed and commonly used insulin, accounting for nearly two-thirds of all insulin treatment visits," the senators wrote. "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."

In its announcement, Novo Nordisk explained its decision to discontinue Levemir by pointing to "global manufacturing constraints;" however, last month, Novo announced plans to purchase pharmaceutical manufacturer Catalent for $16.5 billion, in an effort to ramp up production of the company's hugely profitable GLP-1 weight-loss drugs Ozempic and Wegovy, suggesting the company may be prioritizing profits over patient care.

"We have vigorously advocated for universal access to affordable insulin products," the senators continued. "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."

"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," the senators concluded.

Senator Warren has led the fight for affordable health care and fair practices in the health care industry:

• In March 2024, Senator Warren (D-Mass.) blasted GlaxoSmithKline (GSK) for its price-gouging strategy that may cause millions of children to lose access to one of the few drugs that is appropriate to treat their asthma and allergies in response to GSK discontinuing the brand-name version of Flovent HFA, the go-to inhaler for children.
• In March 2024, Senators Warren and James Lankford (R-Okla.), sent a letter to Majority Leader Chuck Schumer (D-N.Y.) and Minority Leader Mitch McConnell (R-Ky.) to call for immediate action on reforming pharmacy benefit managers (PBMs) in an effort to reduce the cost of prescription drugs.
• In February 2024, Senators Warren and Angus King (I-Maine), with U.S. Representative Lloyd Doggett (D-Texas), led 75 lawmakers to urge the Biden administration to strengthen and finalize its guidance to protect taxpayers and lower prescription drug prices. The lawmakers submitted a public comment supporting the "Interagency Guidance Framework for Considering the Exercise of March-In Rights" and calling for changes to ensure increased transparency, oversight, and accessibility of medical products invented through taxpayer-funded research and development.
• In December 2023, in the wake of the Federal Trade Commission's (FTC) warnings about drug manufacturers' patent abuse, Senator Warren and Representative Pramila Jayapal (D-Wash.) sent letters to the CEOs of 8 pharmaceutical companies urging them to voluntarily remove sham patent claims improperly included in the Food and Drug Administration's (FDA) "Orange Book" and end their unlawful practices that delay competition and drive up costs for patients and taxpayers.
• In December 2023, Senator Warren published an op-ed in Newsweek commending the Biden administration's announcement that price can be considered in the government's decision to march-in on a drug, effectively lowering drug costs, and calling on Americans to fight back against an industry that has been taking advantage of them for decades.
• In December 2023, Senator Warren issued a statement after the Biden administration announced it would issue guidance to federal agencies that would allow the government to seize patents of certain expensive drugs developed with taxpayer support to create more competition and lower prices.
• In December 2023, Senator Warren and Representative Jan Schakowsky (D-Ill.) reintroduced the Affordable Drug Manufacturing Act, bicameral legislation to address the skyrocketing price of prescription drugs and increase competition in the generic pharmaceutical market by establishing an Office of Drug Manufacturing within the Department of Health and Human Services tasked with manufacturing select generic drugs and offering them to consumers at a fair price that guarantees affordable patient access.
• In December 2023, at a hearing of the Senate Finance Committee, Senator Warren highlighted the need for the public manufacturing of generic drugs to address critical drug shortages and ensure access and affordability of prescription drugs for consumers.
• In November 2023, Senators Warren and Mike Braun (R-Ind.) sent a letter urging the Department of Health and Human Services (HHS) Inspector General to determine if vertically-integrated health care companies are hiking prescription drug costs and evading federal regulations.
• On November 9, 2023, Senator Warren sent a letter to Federal Trade Commission (FTC) Chair Lina Khan and Commissioners Bedoya and Slaughter expressing disappointment with the FTC's proposed consent order allowing pharmaceutical giant Amgen to move forward with its acquisition of Horizon Therapeutics (Horizon) and urging the FTC to reject the use of behavioral and structural remedies going forward. In the letter, Senator Warren underscored FTC's responsibility to hold Big Pharma accountable and protect competition and access to pharmaceutical products, given concerns that deals such as this one could raise the price of medicine.
• In October 2023, U.S. Senator Warren and Representative Pramila Jayapal (D-Wash.) sent a letter to the Department of Justice (DOJ) Antitrust Division and the Federal Trade Commission (FTC), urging them to carefully scrutinize UnitedHealth Group's (UHG's) pending acquisition of Amedisys. The lawmakers urged the agencies to scrutinize similar deals, reject behavioral or structural remedies, and oppose any health care acquisition that would threaten competition, increase prices, and reduce quality of care.
• In September 2023, Senator Warren and Representative Becca Balint (D-Vt.), along with a bicameral group of lawmakers, submitted a public comment to the Federal Trade Commission (FTC) and the Department of Justice (DOJ) in support of the agencies' proposed merger guidelines.
• In June 2023, at a hearing of the Senate Finance Committee, Senator Warren raised concerns about how profiteering in Medicare Advantage (MA) is driving vertical consolidation in health care.
• In March 2023, Senator Warren sent a letter to FTC Chair Lina Khan and Commissioners Alvaro Bedoya and Kelly Slaughter urging them to carefully scrutinize CVS Health Corp's (CVS) pending acquisition of Oak Street Health, Inc (Oak Street).
• In February 2023, Senators Warren and Bernie Sanders (I-Vt.) and Representatives Jayapal and Katie Porter (D-Calif.) sent a letter to the USPTO, calling on the agency to give close scrutiny to any of Merck's requests for new patents for Keytruda, a biological treatment used to treat cancer, citing new reports about Merck's ongoing abuse of the patent system to protect its monopoly on the drug.
• In January 2023, Senator Warren sent a letter to Federal Trade Commission (FTC) Chair Lina Khan and FTC Commissioners Alvardo Bedoya and Rebecca Kelly Slaughter urging the agency to closely scrutinize two pending big pharmaceutical mergers: Amgen and Horizon Therapeutics, and Indivior and Opiant.
• In March 2022, Senator Warren called out Big Pharma for price-gouging on prescription drugs and providing misleading information on their high drug prices.
• In February 2022, Senators Warren, Angus King (I-Maine), and Congressman Lloyd Doggett (D-Texas) urged HHS to exercise march-in rights for life-saving cancer drug Xtandi to dramatically lower its price for millions of Americans. She also called out big pharma and insurance companies' tricks to squeeze taxpayers and Medicare beneficiaries. And she called for passage of the Build Back Better Act, which includes provisions that could generate billions in savings and give the Department of Health and Human Services the authority to negotiate prices on some high-price drugs.
• In June 2021, Senator Warren led a letter questioning PhRMA's lobbying efforts to block policies that would lower drug costs for millions of Americans.
• At a Senate Finance Committee hearing in May 2021, Senator Warren called for trade negotiations that put patients over big pharma profits.
• Senator Warren has also introduced legislation that would radically reduce drug prices through public manufacturing of prescription drugs, including the Affordable Drug Manufacturing Act with Congresswoman Schakowsky. With Senator Shaheen, she introduced the End Taxpayer Subsidies for Drug Ads Act, legislation that would close a big pharma advertising loophole.

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