A 2024 poll revealed that around 15.5 million Americans now take injectable weight loss medications like Ozempic, Wegovy, and Mounjaro. But the lesser-known fact is that many people who take these medications are not paying the full sticker price on the brand names, relying instead on a more affordable compounded version. But now, compounded GLP-1s are going away, and millions of Americans who relied on them to assist or maintain weight loss may not be able to afford them anymore.
Brand name semaglutides — Ozempic, Wegovy, and Rybelsus — cost roughly $1,000 per month when not covered by insurance, according to SELF. Historically, these medications have been covered when used to treat type 2 diabetes, but it’s less common for insurance companies to cover them for weight loss alone. On the other hand, a compounded GLP-1 — a generic version made by a compounding pharmacy — would be in the ballpark of $200 to $300.
What are compounded GLP-1s, and why were they a thing?
In 2022, the U.S. Food and Drug Administration (FDA) declared a shortage of tirzapetide and semaglutide, important medications for those with diabetes, as a result of “increased national demand,” likely as they gained traction as weight loss drugs.
That declaration permits compounding pharmacies to make exact copies of drug manufacturers’ brand-name medications. “The route of administration, the concentration, the dosage form is identical to a commercially available product,” says Dr. Michael Ganio, senior director of pharmacy practice and quality for the American Society of Health-System Pharmacists.
Once it became legal to compound generic versions of these drugs, more people could access and afford them. “Compounding usually improves access from a drug shortage perspective, and then also the accessibility from the expense. A lot of these drugs aren’t covered by insurance. The compounded products became very popular because they’re much more affordable,” Ganio says. “That leads us to where we are today with a lot of patients who are losing access, not necessarily because of the shortage, but because of the high dollar amount.”
When are compounded GLP-1s going away?
Many already have. The FDA’s policies on compounding GLP-1s state that the drug shortage is over, and manufacturers can now keep up with national demand. Compounded tirzapetide (Mounjaro) production should have ceased by March 19, according to the FDA ruling. Semaglutide (Ozempic, Wegovy, and Rybelsus) compounding must stop by April 22 for some state-licensed pharmacies, or 503A pharmacies, and by May 22 for other outsourcing facilities, also called 503B facilities.
“503A is your corner drugstore or your hospital pharmacy, and then a 503B is a large outsourcing facility where they compound in large volumes,” says Ganio. When a drug comes off the shortage list, he says most compounders will stop making it immediately. “But if they’ve prepared some product, 503Bs can continue to sell that for up to 60 days.”
An example of a 503B would be the online compounders you can order weight loss medications from, such as hims & hers.
What should you do if you can’t afford the brand-name weight loss medications?
Ganio says it’s difficult to estimate how many of those 15.5 million Americans rely on compounded versions of weight loss medications versus brand-name ones. But he says there is a lot of “contention” over the FDA declaring an end to the shortage, because they don’t have much insight on how much unmet demand there could be when compounders stop making these drugs.
The harsh reality is that for some people, this change could mean they can’t access their medications anymore, at least not in the same easy or affordable way as before. There are some things you can do, Ganio says:
- Ask your doctor if you can be prescribed a cheaper drug. Some manufacturers are offering direct pay models, where you pay cash out of pocket for their medications at half the typical price. For example, using this model, Novo Nordisk charges $499 a month for Wegovy instead of the usual list price of around $1,300. “It’s not as cheap as some of the compounded products that I’ve seen, but much more accessible than the initial list price that these medications were being sold for,” Ganio says.
- Check the manufacturers’ websites for discounts, rebates, coupons, or copay cards that could lessen the out-of-pocket expense.
Ganio notes that compounding these medications is still allowed if the patient requires a dosage that isn’t offered by a commercial product, though as a source told SELF, that loophole may not be very applicable to these medications — the dosing is rarely an issue, and instead, the price tag is.
A word of caution, though: Trying to stock up on compounded versions of the medication is not a great idea, and you should be wary of any pharmacies advertising that you do so. Ganio says most 503A pharmacies’ medications would have around a 10-day shelf life, after which the medications shouldn’t be used.
And if you see compounding pharmacies offering their own versions of injectable weight loss meds after the cutoff dates, you need to really investigate why before buying them. “If you have a compounder that’s continuing to market or sell a product, it’s important to ask why. It may be a red flag if you see that someone’s still marketing those,” says Ganio. “Is this a state-licensed pharmacy, or is it an outsourcing 503B facility? Is it registered with the FDA? Make sure they’re operating within the regulatory framework they should be operating within. If it is a 503A, they should be licensed in that state and following the state regulations. If they are an FDA facility, [check] that they’re following the FDA regulations.”