A new generation of weight loss drugs could have a significant impact on obesity in the United States. But high costs, as well as off-label use from relatively healthy patients, could limit access to the treatments for the patients who need it most.
New weight loss drugs, which are repurposed diabetes medications, "are showing weight loss unlike any other medications we've had in the past," said David Creel, a psychologist and registered dietitian in the Bariatric & Metabolic Institute at the Cleveland Clinic.
For example, Novo Nordisk's Wegovy, or semaglutide, is a higher dose of the company's self-injectable diabetes drug Ozempic. It mimics a hormone called glucagon-like peptide-1 to target areas of the brain that regulate appetite and food intake.
FDA approved Wegovy last year after a clinical trial showed it helped patients lose an average of 15% of their body weight over 68 weeks. Robert Kushner, an obesity researcher at Northwestern University Feinberg School of Medicine who led the clinical trial for Wegovy, called it a "game-changer" and the "start of a new era of effective treatments for obesity."
Similarly, Eli Lilly in June reported promising results for its experimental obesity drug tirzepatide. During the trial, patients lost up to 20% of their body weight. Currently, it has only been approved by FDA to treat Type 2 diabetes under the name Mounjaro, but it will likely soon be approved for weight loss as well, Kaiser Health News reports.
However, health experts note that it's too soon to tell how effective the new medications will be, especially for different patients. In addition, the high cost of these drugs—which can be over $1,000 a month and are not typically covered by insurance—may limit access for many patients.
Advocates argue that insurers should cover weight loss medications similarly to how they cover treatments for cancer or chronic conditions. Currently, Medicare bars coverage for obesity medications for "anorexia, weight loss or weight gain," although it pays for bariatric surgery.
"It's undeniable now that you can achieve substantial weight loss if you stay on medications—and reduce the complications of obesity," said Timothy Garvey, a professor at the University of Alabama-Birmingham. "It will be hard for health insurers and payers to deny."
But some experts say the drugs may not be worth the cost and could increase health care spending.
"If you pay too much for a drug, everyone's health insurance goes up. Then people drop off health insurance because they can't afford it," so providing these weight loss drugs may actually negatively impact the health care system, said David Rind, CMO for the Institute for Clinical and Economic Review.
Another growing issue is the off-label use of diabetes drugs, such as Ozempic and Mounjaro, for weight loss purposes. Although physicians may use their medical discretion to prescribe the drugs to people who are overweight or obese to help them lose weight, some patients who do not meet those criteria are also being prescribed the drugs.
"This is the Hollywood drug," said Patti Stanger, the star and executive producer of the reality show "The Millionaire Matchmaker, who has taken Ozempic herself. "It's nationwide. I have friends in Miami, I have friends in New York who are doing it."
"Everyone wants a quick fix," said Lisa Moskovitz, a registered dietitian and CEO of NY Nutrition Group. However, when people stop taking Ozempic, "you lose that feeling of fullness, that benefit of not being as hungry. And now your hunger signals and cues can become a lot stronger."
Currently, the use of these drugs among people who are relatively healthy has not been studied and is not supported by scientific evidence, the Wall Street Journal writes. Neither Ozempic nor Wegovy have been approved for people with chronic conditions and are not meant to be used for casual weight loss.
"From our standpoint, we don't promote or suggest or encourage any off-label usage at all," said Jason Brett, Novo Nordisk's executive director of medical affairs. He also noted that the company is "not looking at weight loss for cosmetic purposes or episodic weight loss for people who don't fit those criteria from the FDA-approved label indications."
Although physicians are generally able to prescribe medications for off-label use as they see fit, Chanapa Tantibanchachai, an FDA spokesperson said that "[i]t is important to note that the FDA approval (or clearance) of a medical product for one intended use does not assure its safety and effectiveness for other uses."
The American Diabetes Association (ADA) and Mutual Aid Diabetes have both expressed concerns about how off-label use of these drugs may cause shortages and affect patients with diabetes. Robert Gabbay, chief scientific and medical officer for ADA, said he has already seen some of his own patients struggle to fill their prescriptions. (Appleby, Kaiser Health News, 10/13; O'Brien, Wall Street Journal, 10/12)
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