Recent diabetes, obesity drug shortages reveal challenges for prescribers
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Recent shortages of the type 2 diabetes therapies semaglutide and tirzepatide, widely reported in the consumer press, appear to be resolving, according to manufacturers and prescribers.
Beginning in the middle of last year in the United States, but extending globally, the shortages caused numerous challenges for prescribers treating people with type 2 diabetes and with obesity.
The GLP-1 receptor agonist semaglutide in 0.5 mg, 1 mg and 2 mg doses was approved as Ozempic (Novo Nordisk) in December 2017 for treating adults with type 2 diabetes. Semaglutide with the brand name Wegovy was approved at a higher dose of 2.4 mg for chronic weight management for adults in June 2021 and for children aged 12 years and older in December 2022. The first-in-class glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist tirzepatide (Mounjaro, Eli Lilly) was approved in May 2022 for treating adults with type 2 diabetes. In October, the FDA granted fast track designation to tirzepatide for weight management with a decision expected in the coming months.
All three medications are associated with substantial weight loss, and publicity surrounding that potential may have created a run on the pharmacies.
“Typically, we don’t see anything quite like this,” Fatima Cody Stanford, MD, MPH, MPA, MBA, FAAP, FACP, FAHA, FAMWA, FTOS, associate professor of medicine and pediatrics at Harvard Medical School, obesity medicine physician-scientist at Massachusetts General Hospital Weight Center, and equity director in the division of endocrinology in the department of medicine and director of diversity at the Nutrition Obesity Research Center at Harvard University, told Endocrine Today. “This has been, I would say in my career, the most pronounced that I’ve ever seen for any drug access, and I’ve been in medicine for quite some time now.”
Increased demand
In 2022, semaglutide and tirzepatide shortages substantially affected people with diabetes and obesity as well as obesity medicine specialists, endocrinologists, primary care physicians and cardiologists who prescribe these medications. The shortages caused stress for prescribers who have a large percentage of patients on such medications.
“Medication shortages are not a common thing in the United States,” Rodolfo J. Galindo, MD, associate professor of medicine in the division of endocrinology at University of Miami Miller School of Medicine, told Endocrine Today. “We tend to see these shortages for rare indications, for medications that are rarely used. Even a couple of years ago, we had some issues with some medications that were generic for some rare diseases. You don’t see these [shortages] commonly for diabetes.”
Galindo said his patients were “happy” with their experience using semaglutide for type 2 diabetes.
“Then, when semaglutide was approved for obesity, that’s when we started seeing a lot of demand to the point that some patients with diabetes couldn’t get it for their diabetes.”
Galindo and other prescribers attribute at least some of this increased demand to social media influencers who reported using semaglutide and tirzepatide for weight loss. This likely contributed to critical drug shortages, Galindo said.
“Basically, everything went crazy. It gained a lot of attention from the media, but I think the most impressive thing is that on Twitter and other social networks, many of the influencers started saying they were using a medication for diabetes to lose weight, even if they didn’t have diabetes,” Galindo said. “Then there was a lot of demand for weight loss on any dose, whether the drugs were approved for diabetes or obesity. ... Patients were waiting for 2 weeks or 3 weeks to get the diabetes medication that they had been taking for months.”
Stanford, who is also an Endocrine Today Editorial Board Member, estimated that there are nearly 200 million people in the U.S. with diabetes or obesity who may require access to these drugs. She has prescribed these drugs to more than 2,000 patients, she said.
To try to navigate the shortages, Stanford advised patients to try to source their prescription from specialty and mail-order pharmacies, which may have supplies coming from larger warehouses compared with local shops.
“Some patients were traveling far and wide to get medications. Maybe they had a spouse traveling to a less-populated state, and they might have me send the script to that pharmacy in that state so they could get the medication,” Stanford said.
Prescribers were also advised by the manufacturers against writing new prescriptions for these medications to conserve the available supplies for patients already taking them, according to Jamy D. Ard, MD, professor of epidemiology and prevention and co-director of the Weight Management Center at the Wake Forest School of Medicine and an Endocrine Today Editorial Board Member.
Unsatisfactory, unsafe alternatives
For patients with obesity, that meant trying different strategies, Ard said.
“Often, what would end up happening, if you really thought this was the only way that someone was going to get a treatment response, we would start someone on Ozempic, try to get them to the higher dose and then switch over to Wegovy,” Ard said. “The other alternative was to try other GLP-1s, like Trulicity (dulaglutide, Eli Lilly). ... And then we can switch to an equivalent dose of semaglutide once it’s available.”
Still, even dulaglutide — approved in 2014 for treatment of type 2 diabetes and associated with some weight loss — became less available when shortages of semaglutide and tirzepatide became apparent, Galindo said.
Ard noted that some actors took advantage of the shortages to pitch unsafe “alternatives” to semaglutide and tirzepatide.
“You saw things popping up that clearly had no evidence or legitimacy — things like ‘compounded semaglutide’ or some semaglutide-like proteins that were being marketed,” Ard said. “Novo Nordisk came out and said this is not semaglutide and they are the only producer of that particular drug. Clinicians [should] say to patients who might inquire about those types of things that it’s not safe that we know of. ... We see that type of thing in this space all the time.”
Barriers to access
Even without shortages, prescribers and people with diabetes or obesity face day-to-day barriers in accessing their medications.
“The main issue is insurance coverage and prior authorization requirements,” Ard said. “There’s definitely been a significant increase in the number of prior authorizations required, and there is definitely a decrease in the eligibility criteria for getting coverage for these drugs now.”
Stanford agreed.
“I happen to be in Massachusetts, where private insurance plans, particularly if you’re on their top tier, do cover these medications for both obesity and diabetes,” Stanford said. “For those people who are privileged enough to be on the top tier of plans ... coverage is not necessarily an issue.”
However, for patients under MassHealth — the equivalent of Medicaid — these drugs are out of reach, particularly for obesity, Stanford said. Obesity and diabetes affect many people, so putting time and attention into reducing costs to ensure greater access should be a priority.
“I’ve found that some of my older adult patients have continued working to retain their insurance coverage because they didn’t want to lose coverage for their medications, particularly for GLP-1 agonists,” Stanford said.
Addressing drug shortages
Ard said the shortages have lessened, but plans to avoid future shortages are needed.
“The shortages have definitely improved, and a lot of that is based on my understanding of how the company has dealt with the supply chain issues and having redundancy there. I think it was hard to anticipate the demand,” Ard said. “In the future, companies will certainly anticipate that if they have a drug that is effective and has reasonable coverage and access that there will be demand for it because people do want treatment.”
Many factors contributed to the shortages, Galindo said, and he suspects the companies did not expect such high uptake after people realized the drugs approved for diabetes were also effective for weight loss.
“Losing weight is very challenging. I’m not really judging that you want to try [an off-label drug for weight loss],” Galindo said. “But the issue here is that people with a chronic disease like diabetes don’t have it, and that’s when it becomes problematic.”
In February, Novo Nordisk told Endocrine Today that supply disruptions for Ozempic were “due to the combination of incredible demand coupled with overall global supply constraints.” The company said shortages of Wegovy had been alleviated; “however, pharmacies may experience normal delays given the time required to order the product from their local distribution center, and geographical variabilities. ... While production is ongoing, the overall demand for this medicine is still uncertain and will continue to be assessed. Keeping supply stable is a priority.”
Also in February, Eli Lilly told Endocrine Today that shortages of tirzepatide were “due to strong global demand for incretin therapies and uncertainty around competitor incretin shortages.”
The issue of ensuring equity consistently in drug access should never be “one disease against another,” Stanford said.
“All people, regardless of their disease, who would be a good candidate for these medications should be considered,” Stanford said. “My focus is making sure that as many of my patients, regardless of what their socioeconomic status is, can access things, and right now I’m precluded from the ability to prescribe these to my patients who come from lower socioeconomic backgrounds and ... can benefit quite dramatically from many medications.”
Reference:
- Kansteiner F. Novo Nordisk, Eli Lilly replenish type 2 diabetes stars Ozempic, Mounjaro after off-label weight-loss boom. Fierce Pharma. Available at: www.fiercepharma.com/pharma/novo-nordisk-eli-lilly-replenish-type-2-diabetes-stars-ozempic-mounjaro-after-label-weight. Published March 20, 2023. Accessed March 20, 2023.
For more information:
Jamy D. Ard, MD, can be reached at jard@wakehealth.edu.
Rodolfo J. Galindo, MD, can be reached at rodolfo.galindo@miami.edu.
Fatima Cody Stanford, MD, MPH, MPA, MBA, FAAP, FACP, FAHA, FAMWA, FTOS, can be reached at fstanford@mgh.harvard.edu.
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