Why cheaper alternatives to weight-loss drugs like Wegovy, Zepbound will be tougher to get

The days of cheaper alternatives to popular weight-loss drugs like Wegovy and Zepbound are over for some Long Islanders and are numbered for others, pharmacists and compounding industry groups say.

People nationwide who can’t afford the name-brand drugs, which can cost more than $1,000 a month, have been flocking to pharmacies or telehealth companies like Hims & Hers to buy compounded versions, which contain the same active ingredients but often are available at a fraction of the price. But the Food and Drug Administration is phasing in bans on compounded copies of the brand names, with the latest step taking effect Wednesday.

Jessica Baylis, 44, of Greenlawn, who has lost nearly 40 pounds since she began taking compounded tirzepatide in 2023, said she would have difficulty paying name-brand prices. Zepbound and Mounjaro are Eli Lilly's name brands of tirzepatide.

"If I don’t have this medicine available to me, I will 100% gain weight," she said. "It’s sort of like we’re being told, ‘We have this miracle, but you can’t get it.’ "

A 2022 study found that within a year of going off semaglutide, sold under the name brands Wegovy and Ozempic, participants regained an average of two-thirds of their lost weight.

A compounding industry leader estimates that about 10 million Americans take compounded versions of the drugs, at least twice the number who take name brands. Unlike the name brands, compounded versions are not FDA-approved.

After the FDA declared shortages of the drugs over, for tirzepatide in December and semaglutide in February, it told pharmacies and companies they had a few months before they had to stop making copies of the name-brand medications.

Starting Wednesday, large compounders called outsourcing facilities that sell to pharmacies, hospitals and others cannot manufacture compounded tirzepatide. The FDA earlier barred individual pharmacies from creating compounded copies of tirzepatide — although some variations that are not exact copies are still legal.

A federal judge March 5 denied a request by the Outsourcing Facilities Association for a preliminary injunction against the tirzepatide restrictions.

The organization also is suing the FDA over compounding restrictions for semaglutide. They go into effect on April 22 for pharmacies and May 22 for outsourcing facilities. The association argues in its suits that despite assertions by the FDA, Eli Lilly and Novo Nordisk, the maker of Wegovy and Ozempic, a shortage remains.

Eli Lilly said in a statement that Zepbound and Monjouro "are available to meet current and anticipated patient needs."

Large-scale providers of tirzepatide and semaglutide such as San Francisco-based Hims & Hers are among those whose compounded medications comes from outsourcers. 

Expensive alternatives

As the restrictions are phased in, many people’s only option will be expensive name brands, said Joseph Navarra, owner of Town Total Compounding Center in Woodbury.

GoodRx, a website that tracks prescription prices,  recently showed a range of prices in Long Island pharmacies for Zepbound of between $995 and $1,097 a month, for people not using insurance, and for Wegovy of between $1,309 and $2,133 a month.

Navarra said he has sold a compounded version of Zepbound for as little as $300, and a compounded version of Wegovy for as little as $150 a month.

"The medication has been life-changing" for his customers, said Navarra, pointing to how after losing weight, some have been able to come off drugs for heart problems, diabetes and joint pain.

Even if there is no longer a shortage of the medications, he said, "I look at it as a difference between shortage and access. There will be a good amount of patients who won’t have access to the medications because they can’t afford it or their insurance companies won’t cover it."

Although almost all employer health insurance plans cover semaglutide, tirzepatide and similar drugs called GLP-1s when used for diabetes treatment, only 44% of large employers’ plans cover them for obesity, according to a survey released in November by Mercer, which offers benefits consulting.

And even a majority of people whose insurance paid at least part of the cost for the medications said it was very or somewhat difficult to pay for them, according to a poll released in May by the nonprofit health policy organization KFF. That survey found that 12% of U.S. adults had taken GLP-1 drugs, and 6% were currently taking them.

It’s unclear how many of the estimated 10 million or so Americans who use compounded versions of the medications will be affected by the changes, Lee Rosebush, the outsourcing association's chairman, said in an interview. Most compounded drugs likely come from outsourcers, he said.

'Loophole' to restrictions

Baylis said tirzepatide has been "life-changing," giving her more energy and lowering cholesterol and anxiety in addition to making her feel better about herself.

"It makes me nervous if I can’t get medicine that improves my quality of life," she said.

There are exceptions to the new restrictions. But like many patients, Baylis doesn’t know whether she qualifies.

Under the law, an outsourcing facility can only manufacture "an essential copy" of the name brand, Rosebush said. Those are barred for tirzepatide starting Wednesday and May 22 for semaglutide.

But a neighborhood compounding pharmacy, for example, will still be able to make variations of the name-brand drugs.

As with other compounded medications, pharmacies can adjust the dosage of GLP-1 drugs and make other changes, said Maria Mantione, chair of the Department of Pharmacy Practice at St. John’s University in Queens, former chair of the New York State Board of Pharmacy and a former pharmacist in Levittown.

That can create a "loophole" for health care providers to prescribe medications that fall under the FDA exceptions, she said.

Nicole Imbasciani, a nurse practitioner and owner of Rock Star Recovery and Wellness in Massapequa, said of her 75 to 100 patients who take compounded tirzepatide and semaglutide, "almost all" are on a variation, and she believes they won’t be affected by the new restrictions.

Imbasciani, whose insurance covers Zepbound for her own weight-loss treatment, said some patients can’t tolerate the name-brand doses, so she prescribes lower amounts. She also prescribes the addition of B6 for some patients to combat nausea, a common side effect of the medications, and B12 to counter fatigue, another potential side effect.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, a trade group, said providers can prescribe compounded variations to a name brand if they judge it makes a clinical difference for patients. But while he knows of other health care providers who prescribe the two medications with B12 or B6, he said, "there are many who will argue that it still is a copy," and thus covered under the new restrictions.

Yet he doesn't expect the FDA to scrutinize each prescription. "The FDA tries really hard not to question the judgment of a prescriber," he said.

He said he understands why pharmacists and health care providers are concerned about patients on compounded drugs who are unable to afford the name-brand versions. But, he said, "Compounding was never intended to be in competition with the drugmakers."

Not FDA approved

The FDA said its lack of approval for compounded drugs "means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed."

There also are counterfeit versions of drugs, and they can be dangerous because of the uncertainty of what the fake drugs contain, Mantione, of St. John's University, said.

Eli Lilly and Novo Nordisk warned in statements about taking compounded drugs, with Novo Nordisk saying they "expose patients to serious safety and efficacy risks."

Yet although compounded drugs are not approved by the FDA, registered outsourcing facilities are subject to FDA inspections and must adhere to "similar quality standards as Pfizer and the drug manufacturers," Mantione said.

Prices higher in U.S.

About 70% of U.S. adults have obesity or are overweight, conditions "associated with some leading causes of death, including heart disease, stroke and diabetes, and is linked to an increased risk of certain types of cancer," the FDA says.

With the health stakes so high, prices for the medications should be more accessible, Rosebush said, pointing to how Americans pay far more for the drugs than people in other countries.

Wegovy, for example, had a $328 monthly list price in Germany and $1,349 in the United States, according to a KFF analysis of weight-loss drug prices released in August 2023.

In their statements, Novo Nordisk and Eli Lilly pointed to self-pay programs the companies have launched in the last several months that reduce monthly costs for many people to $499 a month, if the drugs are ordered directly through the companies. The starter dose for Zepbound is $349.

But "$500 is still a lot of money for a lot of people," Dr. Craig Primack, senior vice president for weight loss at Hims & Hers, said in an interview.

Much of the company’s compounded semaglutide is manufactured in two outsourcing facilities, so as of May 22, "we’ll be canceling a lot of plans," with money refunded, he said. One-year plans for compounded semaglutide cost $165 a month, he said.

Hims & Hers will continue to sell customized versions of semaglutide for those prescribed it, a company spokesman said later in an email. Prescribers are contracted by Hims & Hers, the spokesman said by phone. 

Primack said either Congress or the FDA should allow broader use of compounded obesity medication. Otherwise, he said, many people in need "will not be able to afford the drug."

By David Olson

david.olson@newsday.com@DavidOlson11

David Olson covers health care. He has worked at Newsday since 2015 and previously covered immigration, multicultural issues and religion at The Press-Enterprise in Southern California.