Piotr Swat/SOPA Images/Sipa USA via AP
Last November, Novo Nordisk announced that Levemir, one of the insulin medications that got a price cut, would be fully discontinued in the U.S. at the end of 2024.
A year ago today, Novo Nordisk announced significant list price reductions on its insulin medications. Unlike co-payment caps or discount cards, these were real cuts in the actual cost to patients and payers, by 75 percent for vials and prefilled injection pens (FlexPens) of NovoLog, and by 65 percent for Novolin and Levemir. The new prices would begin January 1, 2024.
“Novo Nordisk remains committed to ensuring patients living with diabetes can afford our insulins, a responsibility we take seriously,” senior vice president for market access Steve Albers said in a statement.
Eli Lilly and Sanofi, the other two major insulin manufacturers, also cut their prices around that time, mainly due to a Democratic-passed change in Medicaid rebate policy that would have led to significant losses for the three companies. Praised by insulin users and advocates, it was seen as a positive step for a pharmaceutical industry that rarely gives patients much to smile about.
But last November, Novo Nordisk made a different announcement. Levemir, one of the drugs that got a price cut, would be fully discontinued in the U.S. at the end of 2024. (The FlexPen version would be discontinued next month.) Supply disruptions, the company said, would begin to hit patients in January—the same month the price cuts took effect.
The alternative to Levemir that Novo Nordisk makes for the U.S. market sells for over three times as much.
The announcement shocked Alison Smart of Salt Lake City, Utah. Her 15-year-old daughter, a competitive tennis player with Type 1 diabetes, takes Levemir, a type of long-acting insulin that was particularly useful for young people and athletes. “Not everyone realizes how great Levemir is,” Smart told me in an interview. “[But] there’s a whole history in diabetes care, once an insulin goes off-patent, it’s not worth it to make it anymore.”
Smart started a small patient advocacy group called the Alliance to Protect Insulin Choice, and has been working to keep Levemir going. Novo Nordisk, which thanks to its breakthrough GLP-1 weight loss drugs Ozempic and Wegovy now has a higher market capitalization than Tesla, has thus far declined to alter its decision. Smart has spoken to numerous politicians, regulators, global health organizations, and generic manufacturers. She has gotten approving signals from generic producer Civica Rx that they could create a biosimilar alternative to Levemir, which has been off-patent for five years. But, Smart said, Novo Nordisk would have to keep Levemir on the market for three to five years, giving room for Civica to make the generic before patients and insurance companies settled into alternatives.
The Levemir situation shines a light on the high-stakes corporate decisions over prescription drugs, and their impact on patients. Patient advocates say that Novo Nordisk is opting to bolster its weight loss drugs over insulin products, while making sure that its long-acting insulins avoid generic competition. “Taking off an insulin product that has already been on the market and has users,” said Shaina Kasper, policy and advocacy director for diabetes advocacy group T1International, who herself takes Levemir, “in favor of this drug that has a significantly higher profit margin, is putting profits over patients’ lives.”
TYPE 1 DIABETES PATIENTS REQUIRE A CONTINUOUS SUPPLY of insulin, and that can be delivered in two ways. You can attach an automated insulin pump, which delivers the needed amounts accurately. But this must be worn practically all the time, and patients who compete in contact sports may damage the pump. The other option is a series of daily injections, usually taking quick-acting (or bolus) insulin with meals, and long-acting (or basal) insulin to essentially run in the background. Pump users do not need basal insulins; it’s primarily for those who do injections.
Levemir, which came on the market in 2005, is one of only three basal insulins, something that Novo Nordisk has sought to obscure. In a direct letter to Smart, Novo Nordisk named eight different alternatives to Levemir for her daughter. However, six of those eight are variations on the only real alternative molecules: glargine and degludec. “By taking Levemir off the market, you are consolidating more,” said Kasper.
Levemir lasts for 14 hours, while glargine lasts 24 to 36 hours, and degludec, up to 42 hours. While a longer-acting insulin like degludec would seem preferable to the layman, it creates a problem for diabetes patients with habitual changes in body chemistry and hormones, like young people and pregnant women. Degludec also has side effects in some patients, such as nosebleeds.
The primary version of degludec, a drug known as Tresiba, is also made by Novo Nordisk. Tresiba was not one of the insulins that got a price cut; it currently has a list price of $339 a vial, or up to $610 for a FlexPen. After the price cut, Levemir sells for $108 a vial and $162 for a FlexPen. (Tresiba, incidentally, is still on-patent and has no competition.)
Patient advocates say that Novo Nordisk is opting to bolster its weight loss drugs over insulin products, while making sure that its long-acting insulins avoid generic competition.
Meanwhile, glargine is the most common and cheapest-to-produce basal insulin, but it stings when injected because it is made in an acidic solution. It can also lead to hypoglycemia if the injection hits a blood vessel.
Because of these factors, many patients seek Levemir, including Smart’s daughter, who can’t use a pump because of her high activity level. The 14-hour action time allows for adjustments nightly based on blood sugar levels. “My daughter has great glucose control, which is essential if you’re an athlete,” Smart said.
Levemir is also the only basal insulin approved by the Food and Drug Administration for a Pregnancy Category B classification, which means that the fetus would not have a higher risk of harm if their mother uses the drug. “Keeping blood glucose in a really specific range during pregnancy is really important for a healthy baby and parent,” said Kasper.
As recently as 2021, there were over one million Levemir users in the United States, and in 2022 it generated $649 million in revenue, according to the Alliance to Protect Insulin Choice. But there are now closer to 200,000 patients on Levemir, as it has gradually fallen off formularies, the lists of covered medications kept by insurance plans and pharmacy benefit managers. It’s hard to say why, but glargine has a number of biosimilars, which are cheaper generic versions that are attractive to payers wanting to keep down costs.
“We often don’t really get a whole lot of choice over the drugs we take; insurance companies choose for us,” said Kasper, who typically uses a pump but has injections as a backup. Kasper, who was diagnosed with diabetes 12 years ago, was initially on Lantus and then Basaglar, two types of basal insulins in the glargine family, before being put on Levemir. “I found that it really worked well for my body,” she said. “But I just got a prescription refill for the first time, and without my knowledge they switched me over to Basaglar again.”
Kasper didn’t see the change as a big one for her, but those with characteristics that are well suited for Levemir are angered by the discontinuation. It not only eliminates an effective drug that works for patients, and reduces choice to two alternatives, but it casts new light on Novo Nordisk’s pronouncement that it would cut insulin prices. The company received a lot of positive PR for that action. But now, one of the main beneficiaries of the price cuts, Levemir, is being taken off the market before there’s any opportunity to see if pharmacy benefit management companies and insurers would put it back on their formularies, given the lower price.
“The message seems pretty clear,” T1International’s Staci Golar and Larry Price wrote in reaction to the discontinuation. “If you pressure us to lower prices, we’ll make a cursory effort to do so for good optics, but continue to prioritize massive profits and put those who depend on insulin to survive at risk when the public stops paying attention.”
THE ANNOUNCEMENT THAT LEVEMIR SUPPLY WOULD BEGIN to dry up in January gave some patients only two months to adjust, an unprecedentedly short length of time according to Smart. Already, access has been affected, as formularies react by dropping coverage. Some doctors, Smart said, have stopped prescribing Levemir, and other patients are having a hard time finding it in pharmacies.
Chelsea-Lyn Rudder, a spokesperson for the Juvenile Diabetes Research Foundation, said in a statement to the Prospect, “JDRF believes everyone living with type 1 diabetes (T1D) should have access to the insulins that work best for their T1D management. We have shared with Novo Nordisk concerns about the loss of this type of insulin, that we’ve heard from the T1D community.”
Smart’s Alliance to Protect Insulin Choice, which formed after the discontinuation announcement, has been the most forceful in speaking out. Smart immediately called Novo Nordisk, and a representative told her that the discontinuation would be worldwide, though the company has not announced that publicly. Smart then sent a letter to Novo Nordisk’s CEO, Lars Fruergaard Jørgensen, asking that they continue Levemir on behalf of her daughter. “Being a teenager who needs to inject insulin every day is hard enough, and being without this tool that has helped her achieve consistent, good results would be awful,” Smart wrote.
The reply from Novo Nordisk Customer Care mostly restated the announcement in their press release. It said that the discontinuation was decided upon “after thoughtful consideration … due to a combination of factors, most notably global manufacturing constraints, significant formulary losses impacting patient access … and the availability of alternative options in the U.S. market.” The letter proceeded to list the eight alternatives, which are really two.
Novo Nordisk gave essentially the same statement to the Prospect, citing the same combination of factors. “Our top priority is always the health and safety of the patients that use our products,” the statement reads. “We made this decision after careful consideration and are confident that given the advanced notice, U.S. patients will have access to alternative treatments and can transition to other options.”
Rich Pedroncelli/AP Photo
A vial of NovoLog, an insulin also produced by Novo Nordisk
Novo Nordisk’s reference to “global manufacturing constraints” stuck with Smart. Since the breakthrough with Ozempic and Wegovy, Novo Nordisk has been desperate to ramp up capacity for those drugs. It just spent $16.5 billion to buy a manufacturer called Catalent to boost GLP-1 supplies, which have grown popular as a weight loss tool. Analysts have indicated, and these actions reinforce, that Novo Nordisk has gone all in on GLP-1 drugs, to the exclusion of other products with more limited profit outlooks.
In other words, when Novo Nordisk has a supply problem with a medication that is on-patent (like Ozempic and Wegovy), it expends significant resources to alleviate the problem. When the capacity problem is with Levemir, an off-patent drug that it recently had to drop the price on, it discontinues it.
Smart next reached out to Mark Cuban, whose Cost Plus Drug Company for pharmaceutical distribution once flirted with offering insulins directly to consumers, but ended the plan after the price cuts across the industry. Cuban referred Smart to a board member with Civica Rx, the Utah-based generic manufacturer. Smart says that the board member “said Civica could do a biosimilar, but it would take three years and $50 million. And they would need Novo Nordisk to stay in the market for three to five years.”
Why must Levemir remain on the market before a biosimilar is made? In general, biosimilar manufacturers need samples of the drug they’re copying, and if Levemir is discontinued that would become more challenging. In addition, if Levemir leaves the market and patients are given other drugs, it would be difficult to break back in with a biosimilar. Finally, while the insulin itself is off-patent, certain patents associated with Levemir are still alive, and a biosimilar would have to navigate that until those patents expire.
In an email to the Prospect, Cuban confirmed discussions with Smart, “but there haven’t been any action items.” He said that FDA approval would be a big stumbling block for a biosimilar. “I would have to be where we get an existing approved factory,” Cuban said.
Debbi Ford, a spokesperson for Civica, said that their current plans “do not include manufacturing Levemir,” citing their focus on bringing three other insulins to market, including a long-acting glargine.
Melissa Barber, a postdoctoral associate at the Yale School of Medicine who has researched pharmaceutical markets, said that the timeline of three years or more to produce a biosimilar to Levemir was “a bit conservative but one would want to be conservative.” A paper Barber co-authored in 2018 estimated that biosimilar insulins might only cost patients between $72 and $133 per year, if not less.
SMART’S ORGANIZATION HAS COLLECTED NUMEROUS TESTIMONIALS from patients who want to see Levemir stay on the market. “I need this drug to live,” said one. “We didn’t deserve a diagnosis like Type 1 diabetes but since we have it, we do deserve the ability to choose the most effective life-saving insulin that works best for us,” said another. A video produced by Smart includes more testimonials from doctors.
When Smart has talked to officials at the FDA or the World Health Organization, “they said the only thing that would help is government leaders.” She recently spent time in Washington meeting with the offices of 16 senators and eight representatives. So far, no congressional letters have been sent to Novo Nordisk.
Sen. Bernie Sanders (I-VT), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, hosted the CEOs of insulin manufacturers, including Novo Nordisk, at a hearing last May. Jørgensen committed at the hearing to keeping insulin affordable, though he did not say Novo Nordisk would never again raise the price. Sanders did not respond to a request for comment about the Levemir discontinuation.
According to a paper released last year in the Journal of Law and the Biosciences, 62 different insulins have been discontinued since insulin’s discovery in 1919. In many cases, this was due to a replacement with a newer insulin that had patent exclusivity and therefore could be sold at a higher price.
One option for policymakers is to use “march-in rights,” which under the Bayh-Dole Act of 1980 allow the government to redistribute patents for drugs that aren’t being made available to the public on “reasonable terms.” While there is a live debate over whether high prices constitute a lack of reasonable availability, it’s clear that discontinuing Levemir altogether makes it unavailable. But the U.S. has never used march-in rights since the Bayh-Dole Act passed over 40 years ago.
