As demand for Ozempic grows, patients turn to combination versions

When Tina Jacobson tried to take Ozempic to lose weight, her health insurance company denied coverage because she wasn't diabetic.

Instead of paying more than $1,000 out of pocket for type 2 diabetes drugs that lower blood sugar and suppress appetite, a Florida real estate agent turned to a clinic that prescribed cheaper alternatives.

A compounded version made at a specialty pharmacy using Ozempic's active ingredient, semaglutide, costs $350 a month. Ms. Jacobson, who is 5 feet 7 inches tall, started taking it last summer when she weighed nearly 200 pounds and had lost 50 by January.

“I know some people who are taking Ozempic and Wegovy,” Jacobson, 52, said of another semaglutide drug that patients take to lose weight rapidly, “but for the most part, almost everyone I've spoken to is taking a combination medication.”

As the popularity of revolutionary new classes of injectable diabetes and obesity drugs soars, widespread shortages and rising prices of brand-name GLP-1 drugs, including Maunjaro and Zepbound, have driven millions of people looking to lose weight to a booming, less regulated secondary market for knock-offs that are more affordable and easily available online.

The so-called compounded drugs aren't approved by the Food and Drug Administration, which doesn't test them for safety, effectiveness or quality. Compounded drugs play a vital role in the pharmaceutical industry, but they also pose risks. Concerns have been raised in the Ozempic era as telemedicine startups, medical spas and online pharmacies have mushroomed to jump on the bandwagon.

“We urge patients to err on the side of caution,” said a spokesperson for the FDA, which has recently issued several warnings and letters about concerns about combined semaglutide.

Compounding is legal and has been around for decades. For example, drugs may be compounded for patients who are allergic to dyes in brand-name drugs or who need their medication in liquid form rather than pill form.

It would also be allowed if an FDA-approved drug is experiencing an FDA drug shortage. listThe active ingredients in Munjaro and Zepbound, semaglutide and tirzepatide, are both on the list, leading to a flood of tailored combination versions on the market.

“We're in extraordinary times where GLP-1 has become a phenomenon that even drug companies couldn't predict and are unable to keep up with demand,” said Scott Brunner, chief executive officer of the Compounding Pharmacy Alliance. He said the national trade group doesn't track industry figures because it's hard to know how much is dispensed because compounding drugs aren't typically covered by insurance and are paid for out-of-pocket.

In the domestic pharmaceutical hierarchy, the compounds occupy a widely misunderstood position: They are not generic drugs, which the FDA considers to be “bioequivalent” to brand-name drugs and are approved for sale after the patents have expired, following review by the FDA.

Nor are these counterfeits like “those Louis Vuitton handbags you see on the sidewalks of New York,” Brunner said.

The challenge is to recognise the difference, and the responsibility falls on the consumer to understand it.

Wegovy is a semaglutide-based drug used for weight loss.

(Amanda Andrade Rose/The Associated Press)

“Unfortunately, a lot of patients are doing their research on Reddit and TikTok and getting terrible advice,” Brunner says. “I spend half my time sorting through all the questionable stuff going on online.”

Around 42% of online pharmacies selling semaglutide are operating illegally. study The findings were published this month in the medical journal JAMA Network Open.

“Semaglutide products are actively sold without a prescription by illicit online pharmacies, who ship unregistered, counterfeit products,” the study authors said.

Compounded drugs are available through state-licensed pharmacies, federal and Outsourcing Facilityand is performed by a qualified physician.

The opaque online market for compounded semaglutide is keeping regulators busy around the world. In the United States, the FDA is dealing with a range of issues amid surging consumer demand.

The authorities Warning letter To stop the distribution of illegally sold semaglutide, it said the medicine “may be counterfeit, may contain the wrong ingredients, may contain too little, too much or no active ingredient or may contain other harmful ingredients”.

In July, the company said it had received reports of administration errors with its semaglutide injection combination, some of which had led to patients being hospitalized.

Unlike the brand-name drugs Ozempic and Wegovy, which are sold in prefilled injection pens, compounded semaglutide is typically sold in vials and patients are given a syringe and must measure and self-administer the medication. error These problems arose from patients taking the wrong amount of medication and from health care professionals miscalculating dosages when writing prescriptions.

“Many patients who received compounded vials of semaglutide had no experience self-injecting,” the FDA said. “Unfamiliarity with withdrawing medication from a vial into a syringe and confusion over different units of measurement (e.g., milliliters, milligrams, units) may have contributed to dosing errors.”

And last year, the FDA warned that some compounders were smearing their products with Salt Form Semaglutide is different to the one used in brand-name medicines.

“Products containing these salts, including semaglutide sodium and semaglutide acetate, have not been proven safe and effective,” the agency said.

The FDA encourages consumers to carefully investigate online pharmacies. TipFor example, you can only buy from establishments that require a doctor's prescription, are licensed by your state's Board of Pharmacy, and have a certified pharmacist on-site to answer your questions.

Not surprisingly, Novo Nordisk, maker of Ozempic and Wegovy, and Eli Lilly, maker of Maunjaro and Zepbound, do not tolerate their drugs being copied. The GLP-1 drug market is expected to reach $1.2 billion by 2020. $100 billion By 2030, pharmaceutical companies will be vying for dominance in the industry, competing with companies they perceive as encroaching on their sales and brand names.

“Patients should be aware that Novo Nordisk is the only company distributing FDA-approved medicines, including semaglutide, in the United States,” a spokesperson for the Danish healthcare company said. “We do not directly or indirectly supply or sell bulk semaglutide to compounding pharmacies or other entities.”

Last week, the company Reported Ozempic sales increased 30% to $4.26 billion in the second quarter, while Wegobee sales increased 53% to $1.71 billion.

Novo Nordisk announced that it has filed 34 lawsuits against medical spas, weight loss clinics and compounding pharmacies across the country for engaging in the illegal marketing and sale of compounded drugs that purport to contain semaglutide.

But until big pharma produces enough of the drug to get it off the FDA's shortage list, compounded medications will likely continue to make up a big chunk of the GLP-1 market.

Telemedicine companies are doubling down on compounded drug offers, despite the prospect that brand-name drugs will eventually come off the shortage list.

In May, virtual health and wellness platform Hims & Hers Health began selling an injectable formulation of semaglutide, and the company said customers reported losing an average of 10.2 pounds in the first month.

“The interest has been so high we haven't had to do any marketing,” said Pat Carroll, the company's chief medical officer. “There's a staggering number of people across the country who could benefit from this drug who are struggling not just with access but with the cost.”

Compounded semaglutide is sold by healthcare company Hims & Hers.

(He and She)

Hims & Hers began selling the name-brand Ozempic last week, but it costs $1,799 a month. In contrast, the San Francisco company sells a 12-month prescription of combined semaglutide for $199 a month.

Kaylee Stutz, 30, was initially hesitant to try the combination weight-loss drug. She started taking Wegoby in June 2023, but kept running into shortages when she tried to refill her supply at Amazon Pharmacy.

“I went to the doctor and it just said 'not available,' so I kept checking,” the Seattle-based online content creator said. “I was putting off my dose for about 10 days at a time.”

After two months of “anxiety-inducing” periods, she was switched to a combination semaglutide and then to a combination tirzepatide, which she found worked better for her. She went from 230 pounds to now 175.

“In the end, I stayed on the premises because I didn't want to deal with the shortage,” Stutz said. “If I could get the branded stuff, and it was available all the time, I would have stayed there.”