The Food and Drug Administration on Thursday said the active ingredient in Eli Lilly’s weight loss drug Zepbound is no longer in shortage, a decision that will eventually bar compounding pharmacies from making cheaper, unbranded versions of the injection.

“FDA has determined that the shortage of tirzepatide injection products, which first began in December 2022, is resolved,” the agency said in a letter. “FDA continues to monitor supply and demand for these products.”

The agency’s decision, based on a comprehensive analysis, marks the end of a period where certain pharmacies could make, distribute or dispense unapproved versions of tirzepatide – the active ingredient in Zepbound – without facing repercussions for violations related to the treatment’s shortage status.

Compounding pharmacies must stop making compounded versions of tirzepatide in the next 60 to 90 days, depending on the type of facility, the agency said. The FDA said that transition period will give patients time to switch to the branded version.

It’s a blow to some compounding pharmacies, which say their copycat drugs help patients who don’t have insurance coverage for Zepbound and can’t afford its hefty price tag of roughly $1,000 a month. Zepbound and other weight loss drugs are not covered by many insurance plans, but Eli Lilly’s diabetes counterpart Mounjaro is.

It’s the latest in a high-stakes dispute between compounding pharmacies and the FDA over a shortage of tirzepatide, the active ingredient in both Zepbound and Eli Lilly’s diabetes treatment Mounjaro. Eli Lilly has invested billions to expand its manufacturing capacity for tirzepatide as it struggles to keep pace with unprecedented demand.

A trade organization representing compounding pharmacies — the Outsourcing Facilities Association — sued the FDA on Oct. 8 over the agency’s decision to remove tirzepatide from its official drug shortages list just days earlier. The group alleges the FDA acted without proper notice, ignoring evidence that a shortage of tirzepatide still exists. It also argued that the FDA’s action was a coup for Eli Lilly that came at the expense of patients.

Following the suit, the FDA said it would reevaluate removing tirzepatide from the shortages list. That allowed compounding pharmacies to continue making copycats while the agency reviewed its decision.

Compounded medications are custom-made alternatives to branded drugs designed to meet a specific patient’s needs. When a brand-name medication is in shortage, compounding pharmacies can prepare copies of the drug if they meet certain requirements under federal law.

The U.S. Food and Drug Administration does not review the safety and efficacy of compounded products, and the agency has urged consumers to take the approved, branded GLP-1 medications when they are available. 

However, the FDA does inspect some outsourcing facilities that compound drugs, according to its website.

Patients have turned to compounded versions of tirzepatide amid intermittent U.S. shortages of the branded drugs, which carry hefty price tags of $1,000 per month before insurance and other rebates. Many health plans don’t cover tirzepatide for weight loss, making compounded versions a more affordable alternative.

The active ingredient in Wegovy and Ozempic, semaglutide, has been in intermittent shortages over the past two years. But the FDA earlier this month said all doses of those drugs are now available.

The agency has yet to announce whether it is removing semaglutide from its shortage list — a decision that would likely affect even more compounding pharmacies since it is more widely used than tirzepatide.

Wegovy, Ozempic, Zepbound and Mounjaro are under patent protection in the U.S. and abroad, and Novo Nordisk and Eli Lilly do not supply the active ingredients in their drugs to outside groups. The companies say that raises questions about what some manufacturers are selling and marketing to consumers.

Novo Nordisk and Eli Lilly have both stepped in to address illicit versions of their treatments, suing weight loss clinics, medical spas and compounding pharmacies across the U.S. over the past year. The FDA last month also said it had received reports of patients overdosing on compounded semaglutide due to dosing errors such as patients self-administering incorrect amounts of a treatment.

The deadly, targeted shooting of UnitedHealthcare CEO Brian Thompson has unleashed a torrent of pent-up anger and resentment toward the insurance industry, renewed calls for reform and reignited a debate over health care in the U.S. 

Almost no expert, provider, or patient would say U.S. health care works as it should for patients. The problem is deciding how to improve it.

Luigi Mangione, 26, is accused of fatally shooting Thompson outside the Hilton hotel in midtown Manhattan on Dec. 4, as the CEO headed to the annual investor day of his company’s parent, UnitedHealth Group. Investigators have said Mangione was a critic of UnitedHealthcare and the broader health-care industry.

The killing sparked a flood of social media posts voicing negative experiences with insurers, morbid praise and justification for Thompson’s killing and threats toward other insurance executives – igniting frustrations that have bubbled for years. Those reactions drew rebukes from others who condemned them as inhumane after Thompson’s death. 

U.S. patients spend far more on health care than anywhere else in the world, yet have the lowest life expectancy among large, wealthy countries, according to the Commonwealth Fund, an independent research group. Over the past five years, U.S. spending on insurance premiums, out-of-pocket co-payments, pharmaceuticals and hospital services has also increased, government data shows.

Many patients, advocacy groups and experts say the industry and U.S. health-care system are flawed or broken entirely, often burdening Americans who simply need care with exorbitant costs and daunting hurdles. But there is less consensus on the root cause of the insurance issues and how exactly to fix American health care, a complicated and entrenched system for delivering services and treatments that costs the nation more than $4 trillion a year. 

Some experts acknowledged that insurers play a valuable role and must deal with a larger system where multiple stakeholders balance providing care with profit motives. Other experts also noted that insurers have had to grapple with pressures on their businesses, such as lower government reimbursement rates for private Medicare plans and higher medical costs among enrollees in those programs. UnitedHealthcare in particular is also grappling with the fallout from a massive ransomware attack in February targeting its company, Change Healthcare, which processes medical claims.

But patients and advocacy groups stressed that those companies’ decisions often come at the expense of patients. Insurers’ moves to rein in costs for services can often lead to denied or delayed claims, higher premiums and unexpected bills, which can leave patients without care and be the difference between life or death.

The U.S. insurance industry is dominated by private-sector companies such as UnitedHealth Group, CVS Health and Cigna, and operates as a largely for-profit enterprise — in contrast with most other wealthy countries. That means the industry’s primary goal is to generate profit by charging premiums to customers and managing claims to minimize payouts while complying with regulations and satisfying customers.

That leads insurers to weed out care that’s not medically necessary or not backed by scientific evidence, which helps increase their profit margins. But companies can also deny reasonable and necessary claims, preventing patients in genuine need of care from getting it or leaving them with hefty medical charges. 

Tactics include delaying or denying valid claims to limit payouts, increasing premiums in a way that disproportionately burdens lower-income patients and people of color, and requiring prior authorization, which makes providers obtain approval from a patient’s insurance company before administering specific treatments. Insurers increasingly rely on technology, including AI, to review claims, which can lead to inaccurate denials or improper payouts. 

Roughly half of insured adults worry about affording their monthly health insurance premium, according to a March survey from KFF, a policy research organization. The survey added that large shares of adults with employee-sponsored plans and government market coverage rate their insurance as “fair” or “poor” in terms of their monthly premium and out-of-pocket costs to see a doctor. 

A separate KFF survey from 2023 showed that nearly one in five adults had claims denied in the past year. People who used more health services were more likely to have claims rejected, according to the poll. 

No one knows exactly how often private insurers deny claims, since they are generally not required to disclose that data. But UnitedHealthcare, which as the largest private health insurer in the U.S. posted more than $281 billion in revenue last year, is a frequent target for criticism over how it handles claims. 

For example, UnitedHealthcare last year settled a case brought by a severely ill student at Penn State University who claimed the company denied coverage for drugs his doctors determined were medically necessary, leaving him with a bill of more than $800,000. An investigation by ProPublica outlined the lengths UnitedHealthcare went to reject claims, including by burying medical reports. UnitedHealthcare has since settled the case.

Families of two now-deceased customers also sued UnitedHealthcare last year, alleging the company knowingly used a faulty algorithm to deny elderly patients coverage for extended care deemed necessary by their doctors. In court filings earlier this year, UnitedHealth Group said it should be dismissed from the lawsuit because the patients and their families did not finish Medicare’s appeals process for claims.

Some people aired their frustrations with the company’s practices on social media when reacting to Thompson’s death.

One Instagram user wrote in a post that “My condolences are out-of-network.” Another user commented under a CNBC Instagram post about the killing, “Sorry but with the way they be denying coverage for everyday patients.. no comment.”

Celebrating or justifying the death of anyone is “appalling,” said Caitlin Donovan, senior director of Patient Advocate Foundation, which provides case management services and financial aid to Americans with serious illnesses. But she said it is not surprising that people are frustrated with the health-care system. 

“People just want the system to be fair,” Donovan said. “They want to pay a reasonable amount and have their health care covered, and they want to be able to access what their trusted provider is prescribing them.”

Though the issues are well understood, parsing out which stakeholders are to blame is a complicated task.

Some industry experts argued it is necessary for insurers to control costs under the current health-care system. Insurers are mostly paid by employers and government agencies, which set many of the rules around the coverage they offer. 

If insurers paid out every claim they received, premiums would likely skyrocket, said Evan Saltzman, professor in the department of risk management/insurance, real estate and legal studies at Florida State University’s College of Business.

“If you want to keep premiums reasonable, you do need the insurer to police some of the claims being filed,” Saltzman said. He acknowledged insurers sometimes deny “perfectly reasonable claims” and not just unnecessary or fraudulent care. 

He said insurers can also help police bad actors in the health-care system, such as some doctors who attempt to prescribe unnecessary treatments to patients to increase profits. 

Saltzman said one of the underlying causes of insurance issues is “information asymmetry” between insurers and patients. Patients often know more about their personal health risk than their insurance company, but the insurer often knows far more about the health-care networks and coverage details, Saltzman said.

UnitedHealth Group CEO Andrew Witty similarly blamed a lack of transparency in the insurance industry in a New York Times opinion piece on Friday, his first public remarks since the shooting. He said insurers, together with employers, governments and other payers, need to better explain what is covered and how those decisions are made. 

Still, he defended the way insurers make claim decisions, saying behind them “lies a comprehensive and continually updated body of clinical evidence focused on achieving the best health outcomes and ensuring patient safety.”

But Donovan said Witty’s column “missed the mark.” While the health-care system needs more transparency, Donovan said Witty’s proposed solution “puts the onus on patients when that’s not where it should be.” 

Insurance policies are often written with technical language that is difficult to understand. Patients could become confused about what is covered, and may not realize the limitations of their coverage until they try to file a claim, she said.

Donovan believes the root issue is cost — a system built around maximizing prices and revenue, rather than helping patients. 

For example, the industry has limited competition after consolidation, and its traditional payment model reimburses providers based on each service they perform, which can lead to overtreatment and higher costs. 

Drug middlemen called pharmacy benefit managers — which negotiate drug discounts with manufacturers on behalf of insurance plans — also put pressure on other parts of the system. For example, lawmakers and drugmakers have accused PBMs of charging insurers more for drugs than they reimburse pharmacies, pocketing the difference as profit. 

Donovan acknowledged that insurers attempt to negotiate with providers to cut prices for services and products. But she said insurers are often more focused on managing costs for their business than advocating for patients. 

Industry experts don’t expect insurance companies to make material changes to their policies in response to the killing. 

Policy changes at companies alone won’t drastically improve care for patients, according to Veer Gidwaney, the founder and CEO of Ansel Health. His private company offers simplified supplemental insurance for members diagnosed with more than 13,000 conditions

Gidwaney said there will need to be structural changes to the entire industry, which will require harder, longer-term legislative efforts. That may prove difficult with Republicans set to take control of a closely divided Congress for the next two years.

To decrease costs and barriers to access for patients, Donovan said the government could more heavily scrutinize the health-care consolidation that eats up independent providers. She also said legislators could pass more laws to protect patients from surprise ambulance bills and address shortages across the health-care system that drive up costs, such as the limited supply of certain drugs or clinicians. 

The incoming administration under President-elect Donald Trump could also push for more transparency in the health-care industry, according to Stephen Parente, an insurance professor at the Carlson School of Management at the University of Minnesota. Parente served in two different health policy roles in the first Trump administration and has worked directly with UnitedHealthcare’s Thompson. 

He noted, for example, that the Trump administration issued a rule that required most employer-based health plans and issuers of group or individual plans to disclose price and cost-sharing information for covered items and services, which went into effect in July 2022. 

“There might be fresh pressure for denial rates to be put out. I’d like for insurers and Medicare to be transparent about their denial rates,” Parente said. 

Until any significant changes occur, patients can “really try to take control of their own health,” said Michael Hinton, a patient who was diagnosed with a chronic digestive disease called gastroparesis more than 14 years ago. He said that could look like taking notes and asking questions during appointments, tracking insurance payments, learning more about the condition they suffer from and turning to third parties for help.

In Hinton’s case, the Patient Advocate Foundation helped him navigate coverage for a critical surgery that was denied twice by his insurance. 

“I find it so disturbing and sad. It’s just unbelievable,” Hinton said, referring to the fatal shooting earlier this month. “There are other methods of change — and that could look like trying to be your own advocate.” 

Merck on Wednesday said it has snagged the rights to an experimental weight loss pill from Chinese drugmaker Hansoh Pharma, in a deal worth up to $2 billion.

The oral drug has not yet entered human trials, and Merck did not specify which diseases it plans to test the drug on first. Still, it boosts the pharmaceutical company’s chances of winning a slice of the booming obesity drug market, which some analysts expect to be worth more than $100 billion a year by the early 2030s.

Several other drugmakers, including Pfizer and Roche, are racing to develop more convenient obesity pills that can compete with blockbuster injections from Novo Nordisk and Eli Lilly.

Under the terms of the deal, Merck will gain the exclusive global license to develop, manufacture and commercialize Hansoh Pharma’s HS-10535, an experimental oral drug that targets a gut hormone called GLP-1. Novo Nordisk’s popular weight loss drug Wegovy and diabetes treatment Ozempic similarly target GLP-1 to tamp down appetite and regulate blood sugar.

Merck will pay Hansoh $112 million upfront for rights to the drug, with the potential for an additional $1.9 billion in milestone payments and royalties on sales, according to a news release.

Merck said a pretax charge of $112 million, or 4 cents per share, will be included in its fourth-quarter results.

In the release, Dean Li, president of Merck Research Laboratories, said the oral drug has “potential to provide additional cardiometabolic benefits beyond weight reduction.”

Merck CEO Rob Davis early last year said the company was seeking GLP-1 treatments with benefits beyond weight loss.

“I think everyone recognizes weight management is a hard thing to get reimbursed. But if you can show cardiovascular outcome, if you can show diabetes outcome, which you’re starting to see data for, if you can see fatty liver disease benefits … that is an area where we think there’s opportunity,” he said at a conference at the time.

It is the latest transaction involving experimental GLP-1 drugs from China. AstraZeneca last year licensed Chinese company Eccogene’s experimental oral drug, which has since moved into mid-stage development.

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.

There may be a new, unintended side effect linked to Novo Nordisk‘s blockbuster diabetes injection, Ozempic. 

Danish health authorities on Monday said they are asking the European Union’s drug regulator to review the findings of two Danish studies linking Ozempic to an increased risk of a rare vision-threatening eye condition in Type 2 diabetes patients. 

The condition is called non-arteritic anterior ischemic optic neuropathy, or NAION. It is characterized by vision loss due to decreased blood flow to the front part of the optic nerve, which connects the eye to the brain. 

The disease typically occurs without any pain and most commonly affects people ages 50 and above. NAION affects between 2.3 and 10.3 patients per 100,000 people per year in the U.S., according to some estimates. 

The Danish Medicines Agency said it has kept close tabs on NAION as a possible adverse effect of semaglutide, the active ingredient in Ozempic, over the last six months. The agency received 19 reports of the condition in Denmark as of Dec. 10. 

But the overall number of NAION cases in Denmark has increased since Ozempic was introduced in the Danish market in 2018, Jakob Grauslund, professor in eye diseases at the University of Southern Denmark, or SDU, said in a release Monday. Denmark used to see around 60 to 70 cases a year but now has up to 150, added Grauslund, who helped conduct one of the studies. 

It’s the latest potential concern about popular GLP-1s such as Ozempic, which mimic gut hormones to regulate blood sugar and tamp down appetite. Demand for the drug class has soared despite hefty price tags and a handful of unpleasant side effects that are most commonly gastrointestinal, such as nausea and vomiting. 

In a statement Monday, Novo Nordisk said after a “thorough evaluation of the studies” and an internal safety assessment, the Danish drugmaker is “of the opinion that the benefit-risk profile of semaglutide remains unchanged.” The company added that patient safety was a top priority. 

The studies, conducted independently by SDU researchers and other institutions, both found that diabetes patients who used Ozempic were more than twice as likely to be diagnosed with the condition than those who took another diabetes drug. 

The first Danish study was based on data from more than 400,000 diabetes patients, a quarter of whom were treated with Ozempic and the rest with other diabetes drugs. The second study involved data from more than 44,000 Danish diabetes patients who received Ozempic between 2018 and 2024 and nearly 17,000 Norwegian patients who took the drug between 2018 and 2022. 

The studies were posted on medRxiv, a website that posts studies before they’ve been reviewed by outside scientists. Both appear to confirm a link first suggested in a Harvard University study earlier this year. 

Still, the authors of the first SDU study said that the absolute risk of the condition among semaglutide users is low. They added that assuming the risk remains constant over time, the results indicate that a diabetes patient taking Ozempic for 20 years would have a 0.3% to 0.5% chance of developing NAION. 

“Although our findings thereby do not rule out the possibility of an increased risk of NAION when using semaglutide for obesity, the low number of observed events suggests that any potential risk is likely of limited absolute magnitude,” the authors of the first study said. 

They added that additional analyses that are designed differently are needed to further investigate whether Wegovy users, who take semaglutide for obesity, also have an increased risk of the condition.

For now, analysts are less concerned about the risk of NAION and its potential to reduce prescriptions of Ozempic.

“Unless semaglutide is found to be unique among GLP-1s in harboring this risk, prescribing [is] not likely to be affected,” TD Cowen analyst Michael Nedelcovych said in a research note on Monday.

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

If physicians have their way, telehealth is here to stay. That’s according to a new report from Doximity, which found that 83% of doctors would like telemedicine to remain “a permanent part of their clinical practice.”

Doximity runs a digital platform for medical professionals that has been likened to a LinkedIn for doctors. But users can do more than network and read news on Doximity, as the company also offers telemedicine tools like voice calls and video calls.

Since the company has some stake in the game, Doximity published a report on Tuesday that outlines the state of telemedicine in the U.S. and its role in health-care delivery. It surveyed 1,171 of its physician telemedicine users and 131 of its nurse practitioner telemedicine users in August. 

More than 77% of the doctors surveyed said they are using telehealth weekly, and 35% said they’ve incorporated the technology into their daily clinical practice. Nearly 90% of nurse practitioners said they use telemedicine weekly, and 52% do so daily.

“Strong physician support for telemedicine underscores its increasing role in modern health care, with the potential to transform how care is delivered for years to come,” Doximity said. 

Additionally, around two-thirds of physicians said that telehealth had “improved patient outcomes” in their practices, particularly among neurologists, endocrinologists and rheumatologists. Doximity found that endocrinologists, urologists, gastroenterologists, rheumatologists and neurologists were the top adopters of the technology, respectively. 

The most common use of telemedicine in clinical practice is for follow up visits, as 84% of doctors said they will use the technology to carry out those appointments. Next, 60% of physicians said they use telehealth for medication management, 57% said they use it to discuss lab reports or test results with patients and 52% said they use it to help patients manage chronic disease.  

Half of the doctors surveyed said telemedicine had improved patients’ adherence to treatment plans, up from 37% last year. 

Nearly one-third of physicians said the technology has helped them serve more patients per day, and two-thirds said it has helped them better treat their patients. 

Read the full report from Doximity here.

Feel free to send any tips, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.