Diabetes Drug Shortages Leave Patients With Few Options

The diabetes drugs semaglutide (Ozempic) and tirzepatide (Mounjaro) have become so popular as weight-loss medications that many people with diabetes have struggled to get their prescriptions filled.

Shortages Create Frustration

As of this writing, the U.S. Food and Drug Administration officially lists both Ozempic and Mounjaro as “currently in shortage,” and dozens of Diabetes Daily community members have chimed in with their difficulties on our Facebook page. It’s become common to make multiple phone calls before finding a pharmacy with your chosen drug in stock — if you can find one at all.

It’s not easy to stop and start these powerful drugs willy-nilly, a fact that has only added to the frustration of people with diabetes who cannot secure reliable access. Ozempic and Mounjaro both frequently cause uncomfortable gastrointestinal side effects, including nausea, diarrhea, and vomiting. For many people, the side effects become tolerable and eventually subside, only to reoccur when stepping up to a higher dose. If you have already graduated to the full dose of Ozempic, a drug shortage threatens to undo your months of progress titrating to higher doses — and reverse the health benefits, too.

Last August, Medscape reported on some of the “workarounds” that doctors and patients were forced to experiment with during the first major Wegovy and Ozempic shortage. Some doctors attempted to sidestep unavailable smaller starter doses by prescribing liraglutide, a related drug previously approved for weight loss, and later switching back over to Ozempic or Wegovy. Others encouraged their patients to procure the drug in Canada or even Brazil.

Most concerningly, some patients have turned to compounding pharmacies, facilities that create and dispense unauthorized versions of semaglutide. Compounding pharmacies are fully legal, and serve an important need in the American healthcare system, creating custom medications for patients with rare requirements. But the products of these facilities are generally considered risky, because they are not regulated by the FDA. As NBC News recently reported, several states have begun to crack down on compounding pharmacies offering what is essentially homemade semaglutide, because nobody knows if it’s safe or effective.

The popularity of Rybelsus has also been surging, likely boosted by ongoing availability issues for injectable semaglutide. Rybelsus is an oral form of semaglutide, the same medicine as Ozempic and Wegovy, but the pill form of this drug comes with some significant downsides.

A Brief History of Ozempic Shortages

The problems started well over a year ago, in December 2021, when pharmaceutical manufacturer Novo Nordisk was forced to suspend production at one American facility when the contractor’s manufacturing practices didn’t pass muster. That facility was preparing Wegovy, a formulation of semaglutide marketed for weight loss in people without diabetes that is essentially equivalent to Ozempic. Novo Nordisk paused its advertising, and for the next several months it became difficult for new patients to find the drug.

Ozempic, though, was still available, and was about to become a celebrity weight loss sensation. With Wegovy off the market for new patients, demand for the diabetes drug Ozempic skyrocketed, and suddenly people with diabetes found it difficult to acquire the drug they’d been prescribed. Diabetes Daily reported on the first Ozempic shortage in August 2022, and it’s been a rocky road since then, with shortages coming and going.

Last week, Novo Nordisk announced that it would again have to pause its promotion of Wegovy “to avoid stimulating further demand.” The business will strictly limit the availability of starter doses, likely through September. This could again increase demand for Ozempic, which (supposedly) only recently emerged from its own six-month shortage.

Mounjaro Shortages

Like Ozempic, tirzepatide (Mounjaro) has had shortage issues come and go. Mounjaro, which was approved almost exactly one year ago, was tough to find as recently as February.

Though it has flown under the radar in comparison to Ozempic, Mounjaro’s turn in the spotlight is about to come. Mounjaro is arguably the most effective type 2 diabetes medication ever created, and it is also arguably the best obesity medication ever created. In the SURMOUNT trial, the drug helped adults lose 22.5 percent of their body weight in 72 weeks, an extraordinary result on par with bariatric surgery. Some participants on the heaviest dose of Mounjaro lost over 50 pounds.

Eli Lilly, Mounjaro’s manufacturer, is eager for the drug to be approved as a weight loss treatment for people with obesity, a move that will unlock billions of dollars of revenue. The FDA granted the drug a fast-track review, and Lilly reportedly believes that it will be available with the new indication before the end of 2023.

If and when tirzepatide is approved as a weight loss treatment, Lilly will probably choose to market it using a different name than Mounjaro, so as to distinguish between formulations intended for people with and without diabetes. Nevertheless, people with diabetes that already take Mounjaro can be forgiven for being nervous about supply issues. Though Lilly is dramatically increasing its manufacturing capacity, it’s possible that a new wave of publicity will once again drive more demand for tirzepatide than the maker is capable of meeting. That could again cause patients without diabetes to reach for Mounjaro, just as Wegovy shortages led to Ozempic shortages — taking the drug out of the hands of people with diabetes.

E-Businesses Promise ‘Convenient’ Drug Access

The Ozempic and Mounjaro shortages likely wouldn’t have occurred if thousands of doctors hadn’t been eagerly prescribing the drugs off-label for their patients without diabetes. Some experts have decried this practice as ethically questionable, arguing that people with diabetes should have priority for these scarce treatments.

Other doctors, clearly, have no such qualms. In fact, a new industry has sprung up to make it easy for people without diabetes to get prescriptions for the new weight loss drugs. Businesses like Ro, which has recently blanketed New York City with ads for Ozempic and Wegovy, exist to provide prescription medicine effortlessly, without an in-person doctor’s evaluation.

The venerable diet company Weight Watchers recently spent $106 million to purchase a startup named Sequence, another online prescription facilitator like Ro. Sequence calls itself “the most convenient and comprehensive program to access GLP-1 medications so you can jumpstart sustainable weight loss.”

CNN reported that these online drug companies are approving the drug even for people of average weight, despite the belief, widespread among experts and health authorities, that the drugs should be limited to people with a true medical need to lose weight.

Remarkably, this new industry is largely driven by Americans paying full sticker price for their weight loss drugs, as high as $1,000 per month. At the moment, relatively few insurers are covering Wegovy, and fewer still cover the off-label use of diabetes drugs Ozempic and Mounjaro, though e-businesses like Ro and Sequence promise to argue your case with your health insurance provider. Ro’s Ozempic weight loss package, which guarantees a steady supply of the medication, costs $135 per month — and that does not include the cost of the drug itself.

Finally, demand within the diabetes community itself is also only likely to rise: The American Diabetes Association only recently demoted metformin and endorsed the use of GLP-1 receptor agonists, including Ozempic, as first-line treatments for type 2 diabetes.

Semaglutide and tirzepatide will earn their makers untold profits; it seems safe to assume that, at some point, there will be enough of the drugs for people both with and without diabetes. But as of now, it’s impossible to predict the growth of these two drugs, and people with diabetes might be wise to expect more scarcity issues in the near future.

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