— Popular drug faces supply problems and increased demand
Sophie Putka, Enterprise & Investigative Writer, MedPage Today
April 7, 2023
Endocrinologists say patients are once again having trouble accessing injectable medications they use to control type 2 diabetes, this time with tirzepatide (Mounjaro).
Thanks to record demand, supply chain issues, and what some experts say is inappropriate off-label prescribing, endocrinologists said there has been a shortage in recent weeks which has pharmacies backed up and patients changing doses. In some cases, patients have had to switch drugs or go without their medication.
“It’s very frustrating,” said Karl Nadolsky, DO, an endocrinologist at Spectrum Health in Grand Rapids, Michigan. “I get up every morning and I look at patient messages and half of them are due to Mounjaro.”
Similar to recent problems with semaglutide (Ozempic, Wegovy), underlying tirzepatide shortages is the drug’s unprecedented success in controlling type 2 diabetes and sustaining weight loss. Patients who took tirzepatide experienced up to a 20% reduction in body weight, compared with 15% with semaglutide (Wegovy).
Media hype followed, with the Wall Street Journal publishing a story headlined, “The ‘King Kong’ of Weight-Loss Drugs Is Coming.”
Tirzepatide is not approved to treat obesity but was fast-tracked to be considered for the indication last year.
Beverly Tchang, MD, an endocrinologist at NewYork-Presbyterian Hospital and an assistant professor at Weill Cornell Medical College in New York City, said she receives five to ten notifications a day from patients experiencing trouble getting their tirzepatide doses at pharmacies.
“I think everyone underestimated the demand for this medication, which is the first of its class,” she wrote in an email to MedPage Today. Tchang said her colleagues in other states are running into similar problems. “It’s a lack of access driven largely by supply issues and cost,” she noted.
The drug is listed on the FDA Drug Shortages list, but all doses are marked as “available.”
Eli Lilly, the maker of tirzepatide, told Fierce Pharma in February it had resolved the shortage from late 2022 into early this year and was shipping all doses of the drug to wholesalers. A spokesperson for Eli Lilly echoed this in an email to MedPage Today, adding, “following a short period of delayed delivery and restocking of some Mounjaro doses at some pharmacies and wholesalers, it may take time for some pharmacies to get back to full stocking based on the distribution chain.”
“Some people will still need to wait 1-2 days for Mounjaro, as some pharmacies do not stock significant amounts of refrigerated products due to space constraints,” the spokesperson noted.
However, it seems they still haven’t caught up. Nadolsky said he is getting at least six messages from patients a day about the drug. A few months ago, after company reps assured doctors that the 7.5 and 10 mg doses would be more readily available, Nadolsky and his colleagues started renewing prescriptions and going back to patients’ normal doses.
“But then, despite being told that it was all going to be resolved, it’s almost like it’s gotten worse in the past few weeks,” he said, noting that he told his Eli Lilly drug rep that he was still getting messages about the same doses. The rep told him that the company’s supply was stable, but that distributors were lagging behind in stocking pharmacies.
Nadolsky said to get around the shortages, he’ll prescribe his patients the next dose up or down; the medication is titrated in six increasing doses. “It’s okay, generally speaking, probably for patients, but those changes aren’t being done for clinical purposes,” he said. “So, the patients are frustrated, we’re frustrated, because it’s taking time and work and effort that’s unnecessary.”
Some patients who have gone off of insulin because of tirzepatide have had to go back on it, and others who have skipped weeks have become more hyperglycemic, he said.
Malini Gupta, MD, an endocrinologist in Memphis, Tennessee and the director of G2Endo, told MedPage Today that social media has played a role in making demand for this class of drugs for weight loss surge. “The level of difficulty has gone up vertically,” she said. “What’s happening across the board is patients who are on these medications can’t get their medication, and it’s very frustrating because people are getting very angry. The pharmacies can’t keep the medications in stock.”
Nadolsky said he and his peers felt comfortable prescribing the drug off-label for obesity when clinically appropriate, but they’re encountering problems with insurance approval unless they’re prescribing it for type 2 diabetes. “They just became very, very strict,” he said. Without insurance coverage or coupons, tirzepatide costs $1,023 per fill, according to Eli Lilly, making it costly for many patients.
Gupta added that prescribing tirzepatide for weight loss in people without clinical indications has exacerbated the problem. “I can’t tell you how many people I know who are actually abusing it, where they’re going to illegal clinics, and they don’t have any real issues,” she said. “Everybody and their uncle thinks that they have high insulin resistance right now.”
When patients run into problems, she said, she might switch them to another medication. “Sometimes we have to try three or four different medications.”
Tchang, too, said she might switch patient doses or prescribe semaglutide injections, oral semaglutide, dulaglutide (Trulicity), or liraglutide (Saxenda).
But, like Nadolsky, Gupta has run into obstacles with insurers. “It’s a huge burden on physician staffing, because everything now needs prior authorization,” she said. “These things take time. We don’t have the manpower to do this.”
Gupta is also concerned about the likelihood of serious side effects for patients who take GLP-1 receptor agonists. She noted an increased risk for gastroparesis, and said the class of drugs should be avoided with type 1 diabetes, which some people don’t know they have.
Gupta also pointed to a recent study in the American Diabetes Association’s journal Diabetes Care which found a moderate increase in thyroid cancers in patients after 1 to 3 years of use, though the study raised some doubts.
“I think we need to be really looking at this data and take a step back before the widespread abuse takes on a darker turn,” she said.
Sophie Putka is an enterprise and investigative writer for MedPage Today. Her work has appeared in the Wall Street Journal, Discover, Business Insider, Inverse, Cannabis Wire, and more. She joined MedPage Today in August of 2021. Follow
Nadolsky disclosed financial relationships with Novo Nordisk, Boehringer Ingelheim, Sanofi, Eli Lilly, Insulet Corporation, and Amgen.
Tchang disclosed financial relationships with Novo Nordisk, Gelesis, Intellihealth, Cloud Health, Elsevier, Eli Lilly, Merck, and Alexion, and reported receiving research funding from the NIH.
Gupta disclosed financial relationships with IBSA Pharma, Boehringer Ingelheim, AstraZeneca, Eli Lilly, AbbVie, Abbott Laboratories, Horizon Therapeutics, Salix Pharmaceuticals, Amneal Pharmaceuticals, and Janssen Biotech.
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