The end of a shortage of popular weight-loss drugs may mean many people lose access to them

(CNN) — Janet McCaskill says if there’s a diet, she’s done it.

“I tried Weight Watchers. I tried keto. I went to a nutritionist,” said the 58-year-old grandmother, who lives in Knightdale, N.C., outside Raleigh. She said some meal plans worked, but others didn’t.

At the end of 2022, weighing about 212 pounds and concerned about her health after losing her brother and parents to heart disease, McCaskill began using an off-label diabetes drug, Munjaro, to lose weight. This is part of a class of drugs known as GLP-1 receptor agonists, which also include Ozempic, Wegovy, and Zepbound.

“It literally saved my life,” she said.

But it’s expensive, and after switching to a lower-priced version made by a compounding pharmacy last year, McCaskill is now unable to get the drug because the U.S. Food and Drug Administration determined there was a shortage of brand-name drugs. I’m worried that it might be. Medication has finished – This means that you need to stop dispensing the medicine.

A law that allows compounding pharmacies to fill gaps in drug supplies, giving thousands or even millions of people access to expensive GLP-1 drugs at lower prices. It has become. Some doctors were concerned that compounded drugs could pose safety issues. Not FDA approved. But for people like McCaskill, it was a lifeline. And that access is rapidly changing as drug manufacturers dramatically increase supply.

“I’m devastated to say the least,” she said.

McCaskill said she lost nearly 100 pounds in just over a year and has maintained her current weight of about 117 pounds ever since. Blood pressure decreased, as did A1C, a measure of blood sugar, and triglyceride levels. She dramatically changed the way she ate and started exercising more.

McCaskill’s four granddaughters, ranging in age from 6 to nearly 12, were the “biggest reason” she started taking the drug, she said. “They are supportive and I am more active with them than ever before.”

McCaskill, an office manager for an auto restoration and repair business, said his insurance did not cover Munjaro. The drug uses the active ingredient tirzepatide and was approved by the FDA for type 2 diabetes in May 2022. McCaskill said her blood sugar levels were elevated, but she wasn’t diabetic, and many plans don’t include GLP-1 drugs for weight loss.

Instead, she said, she used a coupon from the manufacturer, Eli Lilly, to cut the cost in half and pay out of pocket, but it was still about $500 a month.

When Lilly’s voucher program ended in the summer of 2023, McCaskill health care providers offered another option. It is compounded tirzepatide, a version of the drug that is not FDA approved but is legally available through local pharmacies. It was less than $250 for one month. MacAskill made the switch and continued to see benefits, she said. She has been using that version ever since, and her husband started using it as well.

But now she’s worried they’ll both have to quit.

No longer in short supply

Last week, the FDA updated its database of missing drugs to remove tirzepatide, which had been on the list along with related semaglutide-based drugs Ozempic and Wigovy since 2022 amid unprecedented demand. Updated.

The move means McCaskill’s local pharmacy will have to stop dispensing tirzepatide, as it did. And while this is a sign that branded versions of tirzepatide-based drugs (like the diabetes drug Mounjaro and the approved weight-loss treatment Zepbound in late 2023) will become more widely available, MacAskill said caused people to panic.

“I worked until almost 10 o’clock last night answering patient questions,” said Michelle Kessler, a physician assistant at Durham Women’s Clinic in North Carolina and a health care provider in MacAskill. “All the patients I treat are doing very well, and then suddenly, without warning, they stop treatment.”

The FDA says compounding drugs that are “essentially copies of over-the-counter drugs” is permitted during shortages, but not in “regular or excessive quantities” once the shortage is resolved. The department said only those allowed.

Compounding is often done when a patient needs to make a tweak to a drug, perhaps because they are allergic to one of the ingredients in the original version or because they want a liquid instead of a pill.

“If you walk into a bakery and want a chocolate cupcake with white icing, we’ll make it. If you want a vanilla cupcake with blue icing, we’ll make it. ” said Jennifer Birch, pharmacist and owner of Central Compounding Center in Durham, where Dr. Kessler sends patients for compounded tirzepatide. “We can do it any way you want.”

Her pharmacy also makes medicines for pets, and can tweak flavors based on the animal’s preferences, such as fish, chicken, and sometimes bubble gum.

“How did you know that cats like bubble gum?” Birch said.

But lately, she said, her employees have been working around the clock on formulas of tirzepatide and semaglutide. Birch said that in the past six weeks, he has filled about 900 prescriptions for combination tirzepatide and 500 for combination semaglutide, using active ingredients purchased from chemical suppliers and using official testing. The company uses a method called “to ensure that products meet quality standards”. standard.

For compounded tirzepatide, Birch Pharmacy charges between $200 and $400 per month, depending on the dose.

Without insurance, Mounjaro costs $1,069 a month and Zepbound costs $1,060, Lilly said. The company also offers a savings card for Zepbound for about $650 per month for certain patients with commercial insurance that does not cover the drug.

In August, Lilly also launched a lower-dose, cheaper version of Zepbound in single-dose vials. The patient must collect the medicine and inject it using a needle and syringe. The usual form of this medication is in an auto-injector pen.

The vials can be purchased out-of-pocket through Lilly’s program called LillyDirect, which facilitates access to doctors and shipping of medications to patients. The lowest dose for four weeks costs $399, and the next dose (the one Mr. MacAskill is taking) costs $549.

“Many of us won’t be able to afford to keep paying this,” McCaskill said.

“Price is not the basis”

Evan Sagerman, an analyst at financial firm BMO Capital Markets who closely follows Lilly and semaglutide-based manufacturer Novo Nordisk, said prescriptions for tirzepatide and semaglutide are not tracked through traditional channels. It is unclear how many people are using the compound. Drugs called Ozempic and Wigoby.

He said some estimates put combination prescriptions at 20% of all prescriptions for the drug.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said millions of people may be using the compounded version and many may not be able to switch. We estimate that there is.

“While price is not a basis for dispensing a combination drug, the fact is that many patients could afford a combination of tirzepatide, but probably cannot afford the FDA-approved drug,” Bruner said. said.

His organization asked the FDA for at least 60 days before stopping compounding to “ensure continuity of patient care.” He said he has heard from more than a dozen member pharmacies that branded tirzepatide products are still not available through the ordering system, even though the shortage has been resolved.

“Patients and prescribers continue to experience intermittent local supply disruptions as products move through the supply chain from manufacturers and distributors to local pharmacies,” the FDA said in a statement on resolving the tirzepatide shortage. There is a possibility of being attacked,” he admitted.

In response to an inquiry into the 60-day buffer request, the FDA said it does not discuss its interactions with companies.

Compounding has made authentic medicines available to people who would otherwise not be able to find or purchase them, but the practice is not regulated by the FDA like branded and generic drugs. may involve risks.

“Doctors ask me all the time…’How do I know that the combination drugs my patients are taking are safe and effective?’ And I say, ‘You’re not.’ “I think so,” said Dr. Angela Fitch, chief medical officer at care provider Knownwell and past president of the Obesity Medicine Society. “That’s always been a problem.”

The FDA has received reports of dosing errors with semaglutide-containing products, some of which have resulted in hospitalizations, and some products sold by compounders are labeled as “used in approved drugs.” It warned that a salt form of semaglutide, a different active ingredient, was being used. ” also warns about counterfeit medicines and medicines sold incorrectly as “for research purposes” or “not for human consumption”, which may be harmful. The agency stated.

And Lilly and Novo Nordisk have taken legal action against some medical spas, weight loss clinics, pharmacies and other companies selling the compounded products, saying they pose a “significant risk to patients.” Novo Nordisk this week published the results of a study it conducted in the journal Pharmaceutical Research that found impurities and low concentrations of active ingredients in some compounded versions of its medicines.

Is the formulation of GLP-1 finished?

However, even if the shortage is resolved, it seems unlikely that drug compounding will be completely completed. For now, semaglutide remains on the FDA’s shortage list at the lowest dose of Wegoby, the version approved for weight loss. Novo Nordisk said it continues to invest to increase manufacturing capacity, but did not say when the shortage would be completely resolved.

Even so, companies whose business models are built around compounding, such as telemedicine provider Hims and Hers, are under pressure to provide doses different than those approved by the FDA. , they might find a way to continue offering a formula version. The company told analysts on its quarterly earnings conference call in August that it sees a path to “overcoming the shortage situation” by providing “personalized GLP-1 doses that increase the number of doses available commercially for patients.” He said he is doing so.

MacAskill said he hopes Lilly will consider further lowering the price of its drug to make it more accessible to people who rely on combination tirzepatide. And Fitch criticized insurers’ lack of coverage for obesity treatments.

Trial data shows that most people who stop taking GLP-1 drugs regain a significant amount of the weight they lost, and MacAskill says she’s never reversed the health improvements she’s seen. He says he doesn’t want to.

“I’ve heard that some people are trying to split their doses, but I’m scared to do that,” she said. “When it’s working 100% for me, I don’t want to mess with anything.”