Novo Nordisk‘s blockbuster diabetes drug Ozempic may decrease the risk of opioid overdoses in certain patients, demonstrating its potential as an alternative treatment for opioid use disorder, according to a new study released Wednesday. 

The active ingredient in Ozempic, semaglutide, was associated with a “significantly lower” opioid overdose risk than other diabetes medications in people diagnosed with both Type 2 diabetes and opioid use disorder, said the paper published in JAMA Network Open. 

The results suggest that Ozempic could offer potential as a tool for addressing the ongoing U.S. opioid epidemic, which was declared a public health emergency in 2017. There are currently three effective medications to prevent overdoses from opioid use disorder, but a new alternative is needed because some patients simply don’t use them, said lead study co-author Dr. Rong Xu, a biomedical informatics professor at Case Western Reserve University. 

In 2022, only about a quarter of patients with opioid use disorder received recommended medications for it, and many discontinued treatment within six months, according to the Centers for Disease Control and Prevention. The National Center for Drug Abuse Statistics says opioids are a factor in around 72% of overdose deaths in the U.S. 

The study results also add to mounting evidence that a highly popular class of diabetes and obesity treatments called GLP-1s may have several health benefits beyond regulating blood sugar and promoting weight loss. Novo Nordisk, its rival Eli Lilly and independent researchers have been racing to study those drugs’ potential in patients with chronic conditions ranging from kidney disease and sleep apnea to addictive behaviors such as nicotine and alcohol use.

In the study released Wednesday, researchers from Case Western Reserve University and the National Institutes of Health analyzed the electronic records of nearly 33,000 patients who were prescribed semaglutide or other diabetes medications between December 2017 and June 2023. The study was not funded by Novo Nordisk. 

Around 3,000 people were prescribed semaglutide injections, while the remaining patients received treatments that ranged from insulins to older GLP-1s for diabetes. That includes dulaglutide, the active ingredient in Eli Lilly’s drug Trulicity, and liraglutide, which is the active ingredient in Novo Nordisk’s Victoza. 

Researchers monitored how many opioid overdose cases occurred in patients during a one-year period after they stopped treatment with semaglutide or other drugs. For example, there were 42 cases of opioid overdose among a group of patients that received semaglutide, compared with 97 cases among another group that received insulins, according to the study. 

That reflects a 58% lower risk of opioid overdose in patients who took semaglutide, Xu said.  

But Xu noted the study has limitations since it relies on data from electronic health records.

More research, specifically clinical trials that randomly assign patients to receive semaglutide or other treatments, is needed to confirm how much Ozempic and other GLP-1s can help those with opioid use disorder, according to the study authors. Those randomized studies can also determine whether those treatments are beneficial to the general opioid use disorder population or only certain patients with the condition.

“The extent to which GLP-1 medications could benefit treatment of opioid use disorders and help prevent overdoses is unclear,” Dr. Nora Volkow, lead study co-author and director of the National Institute on Drug Abuse of the National Institutes of Health, said in a statement to CNBC. “The preliminary findings from this study point to the possibility that GLP-1 medications may have value in helping to prevent opioid overdoses.”

Xu added that the researchers plan to study semaglutide in patients with opioid use disorder and obesity. 

Novo Nordisk‘s top executive faced a Senate grilling on Tuesday over the high prices of the company’s weight loss drug Wegovy and diabetes treatment Ozempic, as demand for both injections soars in the U.S. 

Novo Nordisk CEO Lars Fruergaard Jørgensen did not explicitly promise lawmakers at a Senate Health, Education, Labor and Pensions Committee hearing in Washington, D.C., that he would slash prices for the two drugs.

But Jørgensen said he wants to work with them on policy solutions that will address the “structural issues” that drive up prescription drug costs. He also committed to sitting down with pharmacy benefit managers – middlemen who negotiate drug rebates with manufacturers on behalf of insurers – to “collaborate on anything that helps patients get access and affordability.”

That pledge came after Sen. Bernie Sanders, the Vermont independent who chairs the Senate panel, said he received commitments in writing from all of the major PBMs that they would not limit coverage of Wegovy and Ozempic if Novo Nordisk reduced their list prices. The hearing comes roughly five months after Sanders opened an investigation into the Danish drugmaker’s pricing practices. 

“All we are saying, Mr. Jørgensen, is treat the American people the same way that you treat people all over the world,” Sanders said during the hearing Tuesday. “Stop ripping us off.”

He noted that Novo Nordisk has raked in nearly $50 billion in sales from Wegovy and Ozempic, with most of that revenue coming from the U.S. Sanders contends that Novo Nordisk charges Americans substantially higher prices for its blockbuster drugs than it does for patients in other countries. Before insurance, Ozempic costs nearly $969 per month and Wegovy costs almost $1,350 per month in the U.S. 

Meanwhile, both treatments can cost as little as under $100 for a month’s supply in some European countries, according to a release from the committee. Ozempic costs just $59 in Germany, while Wegovy costs $92 in the U.K.

Sanders also said last week that the CEOs of major generic pharmaceutical companies have told him that they could sell a version of Ozempic for less than $100 a month at a profit. There are currently no generic alternatives to Ozempic available in the U.S. 

Major PBMs, including UnitedHealth Group‘s Optum Rx and CVS‘ Caremark, and some health plans said $100 monthly list prices for Wegovy and Ozempic would help make those drugs more widely available to patients, according to a release from Sanders.

That could undercut Jørgensen’s claim in his written testimony that PBMs are to blame for the high list prices of Novo Nordisk’s drugs and “exercise near-total control over the ability of hundreds of millions of Americans to get the medicines they need at affordable prices.” The company has argued that it needs to be able to pay rebates to those middlemen to get their drugs on formularies, or lists of medications covered by insurance.

Jørgensen noted that the written promises that Sanders received from PBMs are “new information to me,” but said he understands “that perhaps the PBMs have changed their minds.”

Novo Nordisk has argued that it has spent billions to research, develop and expand manufacturing for the treatments and is funneling more money into researching their potential to treat other obesity-related health conditions. That investment has extended and improved the lives of millions of Americans, which helps reduce the health-care costs associated with obesity and diabetes, according to written testimony from Jørgensen.

During the hearing, Jørgensen said the company has fought to secure public and private insurance coverage for the medications.

He also in part blamed the “complex U.S. healthcare system” for making it difficult for patients to access affordable prescription drugs, noting that “no single company alone can solve such vast and complicated policy challenges.”

Jørgensen promised that Novo Nordisk will “remain engaged and work with this committee on policy solutions to address the structural issues that drive up costs.”

But Jørgensen contended that lowering prices could have consequences, saying it could lead to less insurance coverage.

In his written testimony, Jørgensen said Novo Nordisk’s insulin product Levemir was previously available to 90% of U.S. patients through formularies. But insurers began to drop coverage of the insulin after Novo Nordisk cut its list price, leading to only 36% of patients having access.

That eventually drove the company to discontinue the insulin, Jørgensen said in his written testimony.

Sanders and other lawmakers, health experts and insurers have warned that the insatiable demand for Novo Nordisk’s drugs and similar weight loss and diabetes treatments from rival Eli Lilly could potentially bankrupt the U.S. health-care system unless prices drop.

Both drugmakers make GLP-1s, which mimic hormones produced in the gut to tamp down a person’s appetite and regulate their blood sugar. Eli Lilly’s weight loss injection Zepbound and diabetes drug Mounjaro similarly cost around $1,000 per month before insurance and other rebates.

In a release, the Senate Health Committee said it would cost the U.S. $411 billion per year if half of all Americans took weight loss drugs from Novo Nordisk and Eli Lilly. That’s $5 billion more than what Americans spent on all prescription drugs in 2022. 

Medicare spent $4.6 billion on Ozempic in 2022 alone, according to health policy research organization KFF. 

Other insurers and employers have implemented strict requirements to control weight loss drug costs, or have dropped coverage of those treatments altogether. Many health plans cover GLP-1s for diabetes, but not for weight loss. The federal Medicare program doesn’t pay for weight loss treatments unless they are approved and prescribed for another health condition. 

The hearing comes as the Biden administration and lawmakers on both sides of the aisle try to rein in health-care costs in the U.S., in part by pressuring the pharmaceutical industry and drug supply chain middlemen. On average, Americans pay two to three times more than patients in other developed nations for prescription drugs, according to a fact sheet from the White House.

Notably, Ozempic will likely be subject to the next round of price negotiations between manufacturers and Medicare — a key provision of President Joe Biden‘s Inflation Reduction Act that aims to lower costs for seniors. Wall Street analysts say Ozempic will likely be eligible for negotiations by the time the next round of drugs is selected in 2025, for price changes that will go into effect in 2027.

Lawmakers asked Novo Nordisk to commit to not suing the federal government if Ozempic and Wegovy are selected for the next round of negotiations.

Jørgensen did not explicitly make that commitment, noting that the company believes the talks are “not a fair negotiation, but actually price-setting” that will have negative consequences for drug innovation.

A version of this article first appeared in CNBC’s Healthy Returns newsletter, which brings the latest health-care news straight to your inbox. Subscribe here to receive future editions.

Good afternoon! Wegovy, the blockbuster weight loss treatment from Novo Nordisk, tops the list of drugs that could soon become part of the second round of price negotiations between manufacturers and Medicare. 

That’s according to a paper published last week in the Journal of Managed Care & Specialty Pharmacy. By February, the government will unveil the next 15 costliest Medicare Part D drugs that will be subject to the talks, for price changes that will go into effect in 2027. 

The Biden administration last month announced new negotiated prices for the first 10 Medicare Part D drugs selected for the talks. Those prices will take effect in 2026. 

Medications containing the same active ingredient and manufactured by the same company will be considered a single drug for the talks, according to guidance from the Centers for Medicare & Medicaid Services. The researchers said that’s why they expect all of Novo Nordisk’s three branded drugs containing semaglutide – Wegovy, the diabetes injection Ozempic and an older diabetes pill called Rybelsus – to be selected for the talks as a single product.

That may be a big deal for older adults who use those treatments, which each carry price tags of around $1,000 per month before insurance. However, it’s still unclear how much Medicare could negotiate down those costs — and how much patient costs would fall after insurance and rebates. 

The Biden administration, lawmakers and patient advocates have long criticized the Danish drugmaker for the high list prices of its obesity and diabetes drugs. Novo Nordisk’s CEO Lars Fruergaard Jørgensen faced a Senate grilling on Tuesday over those prices. 

While Jørgensen did not commit to lowering prices of Wegovy and Ozempic, he vowed to “collaborate” with pharmacy benefit managers “on anything that helps patients get access and affordability.” He also pushed back on Medicare price negotiations when asked about the potential selection of Wegovy and Ozempic, calling the talks “price-setting” that will have negative consequences for drug innovation.

Medicare Part D doesn’t cover weight loss treatments unless they are approved and prescribed for another health condition. But Wegovy could make the list for negotiations because it is now approved to reduce the risk of major cardiovascular complications, making it likely that some Part D plans have started covering the treatment, according to the researchers. 

Under CMS guidance, drugs must be on the market for at least seven years without generic competitors before Medicare can select them for price talks. Semaglutide will have been on the market for seven years and one month by February and does not have any generic equivalents.

Other researchers and Wall Street analysts have said they expect Ozempic to be subject to negotiations because of how much Medicare Part D spends on the treatment. 

The program spent more than $5.6 billion on semaglutide drugs in 2022, which only reflects spending on Ozempic and Rybelsus since Wegovy was not covered at the time, the paper said. Researchers also projected that Medicare Part D spent nearly $7.5 billion on Ozempic and Rybelsus in 2023, which is $3 billion higher than spending for the second-highest eligible drug. 

They noted they likely “underestimated” their projected spending figures for semaglutide

The other drugs expected to be subject to price talks include GSK‘s Trelegy Ellipta, a prescription inhaler used to treat asthma and chronic obstructive pulmonary disease, and Xtandi, a rheumatoid arthritis medication from Astellas Pharma. 

Still, researchers said the final list of drugs selected will depend on whether generic versions launch before February. 

We’ll be following the next round of Medicare drug price negotiations closely, so stay tuned for our coverage. 

Feel free to send any tips, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.

The Federal Trade Commission on Friday sued three large U.S. health companies that negotiate insulin prices, arguing the drug middlemen use practices that boost their profits while “artificially” inflating costs for patients. 

The suit targets the three biggest so-called pharmacy benefit managers, UnitedHealth Group’s Optum Rx, CVS Health’s Caremark and Cigna’s Express Scripts. All are owned by or connected to health insurers and collectively administer about 80% of the nation’s prescriptions, according to the FTC. 

The FTC’s lawsuit also includes each PBM’s affiliated group purchasing organization, which brokers drug purchases for hospitals and other health-care providers. The agency said it could recommend suing drugmakers Eli Lilly, Sanofi and Novo Nordisk in the future as well over their role in driving up list prices for their insulin products.

A UnitedHealth spokesperson said the suit “demonstrates a profound misunderstanding of how drug pricing works, noting that Optum RX has “aggressively and successfully” negotiated with drug manufacturers.

A CVS spokesperson said Caremark is “proud of the work” it has done to make insulin more affordable for Americans, adding that “to suggest anything else, as the FTC did today, is simply wrong.”

And, a spokesperson for Express Scripts said the suit “continues a troubling pattern from the FTC of unsubstantiated and ideologically-driven attacks” on PBMs. It comes three days after Express Scripts sued the FTC, demanding that the agency retract its allegedly “defamatory” July report that claimed that the PBM industry is hiking drug prices.

PBMs sit at the center of the drug supply chain in the U.S. They negotiate rebates with drug manufacturers on behalf of insurers, large employers and federal health plans. They also create lists of medications, or formularies, that are covered by insurance and reimburse pharmacies for prescriptions. The FTC has been investigating PBMs since 2022. 

The agency’s suit argues that the three PBMs have created a “perverse” drug rebate system that prioritizes high rebates from drugmakers, which leads to “artificially inflated insulin list prices.” It also alleges that PBMs favor those high-list-price insulins even when more affordable insulins with lower list prices become available. 

The FTC is filing its complaint through its so-called administrative process, which initiates a proceeding before an administrative judge who would hear the case.

“Millions of Americans with diabetes need insulin to survive, yet for many of these vulnerable patients, their insulin drug costs have skyrocketed over the past decade thanks in part to powerful PBMs and their greed,” Rahul Rao, deputy director of the FTC’s Bureau of Competition, said in a statement. 

“The FTC’s administrative action seeks to put an end to the Big Three PBMs’ exploitative conduct and marks an important step in fixing a broken system—a fix that could ripple beyond the insulin market and restore healthy competition to drive down drug prices for consumers,” Rao continued. 

Roughly 8 million Americans with diabetes rely on insulin to survive, and many have been forced to ration the treatment due to high prices, according to the FTC.

The White House has no comment on the FTC’s suit, but has “made clear that no one should pay higher prices because of corporate greed,” White House press secretary Karine Jean-Pierre said in a statement Saturday.

President Joe Biden‘s signature Inflation Reduction Act has capped insulin prices for Medicare beneficiaries at $35 per month. That policy currently does not extend to patients with private insurance.

The Biden administration and Congress have ramped up pressure on PBMs, seeking to increase transparency into their operations as many Americans struggle to afford prescription drugs. On average, Americans pay two to three times more than patients in other developed nations for prescription drugs, according to a fact sheet from the White House.

The FTC said it remains “deeply troubled” by the role insulin manufacturers play in higher list prices, arguing that they inflate prices in response to PBMs’ demands for higher rebates. Eli Lilly, Sanofi and Novo Nordisk control roughly 90% of the U.S. insulin market.

For example, Eli Lilly’s Humalog insulin had a list price of $274 in 2017, a more than 1,200% increase from its $21 list price in 1999, according to the FTC.

The FTC said all drugmakers should “be on notice that their participation in the type of conduct challenged here raises serious concerns.”

An Eli Lilly spokesperson said the FTC’s suit concerns “aspects of the U.S. health care system that we have long been advocating to reform.” They added that the company last year became the first to cap out-of-pocket costs for all of its insulins at $35 per month for people with private insurance. Eli Lilly also cut some insulin list prices by up to 70%.

Sanofi last year announced a similar $35 monthly price cap for its most commonly prescribed insulin. Novo Nordisk last year also said it would slash the list prices of some of its popular insulins by up to 75%.

A spokesperson for Sanofi said the company has not seen and will not comment on the FTC’s complaint against PBMs. But the French drugmaker agrees with the FTC’s claim that PBMs have “leveraged their position as powerful industry middlemen and have exploited rebates…to benefit themselves while increasing costs for patients and payers at the same time.”

A Novo Nordisk spokesperson said the company is “committed to ensuring patients have affordable access to their medicines, including insulin.” Novo Nordisk does not control the prices patients pay at the pharmacy in the “complex U.S. healthcare system,” the spokesperson noted, pointing to the company’s insulin savings card programs.

Correction: This story has been updated to correct a quote from the FTC.

Every weekday, the CNBC Investing Club with Jim Cramer releases the Homestretch — an actionable afternoon update, just in time for the last hour of trading on Wall Street.

The CEO of Novartis said Wednesday that the Swiss pharmaceutical giant does not plan to enter into the “frenzy” of weight loss drugs, preferring instead to focus on areas where it can build a “unique position.”

Speaking to CNBC, Vas Narasimhan said that the company was researching treatments that deal with the secondary effects of weight loss, but that it does not plan to compete directly with dominant obesity drugmakers Novo Nordisk and Eli Lilly.

“I think just to follow on the frenzy now would not be the right move for Novartis,” he told CNBC’s “Squawk Box Europe.”

“With obesity right now, we have two very entrenched large players, and I think for future entrants you have to find something new, some sort of new angle that either reduces the nausea and the vomiting or gives patients the ability to lose their weight and retain their muscle,” he said, highlighting existing work in such areas within Novartis’ research labs.

Obesity drug competition has been ramping up over recent months, with major players such as Roche and Pfizer entering the market, which is estimated to be worth up to $200 billion within the coming decade.

However, Narasimhan said his company was targeting areas “we know we can win.” Those include treatments for diseases such as Alzheimer’s, Huntington’s and Parkinson’s, as well as various cancer therapies.

In particular, he said he saw a sizeable market opportunity within its growing radioligand therapies (RLTs), a cancer treatment which targets cancerous cells. So far, the company has made two acquisitions and launched two medicines within the space.

“That’s an area where we think we could build a $20 billion-plus business over time and hopefully build a unique position rather than chasing the other markets,” he said.

“These are places where I feel like we have the right to win,” he added.

His comments come after the company received approval Tuesday from the U.S. Food and Drug Administration for its Kisqali metastatic breast cancer drug to be used to treat patients with earlier stages of the disease.

Novartis shares were down 0.3% by 9:30 a.m. London time Wednesday, after a brief pop at the session open.