A new generation of weight loss drugs could have a significant impact on obesity in the United States. But high costs and off-label use by relatively healthy patients could limit access to treatments for those who need them most.
New weight-loss drugs show promise – but are expensive
New weight-loss drugs, which are repurposed diabetes drugs, “show weight loss unlike any other drug we’ve had in the past,” said David Creel, a psychologist and registered dietitian at the Bariatric & Metabolic Institute In 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 study 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 Wegovy’s clinical trial, called it a “game changer” and the “beginning of a new era of effective treatments for obesity.”
Similar, Eli Lilli reported promising results for its investigational anti-obesity drug, Tirzepatide, in June. During the study, patients lost up to 20% of their body weight. It’s currently only approved by the FDA to treat type 2 diabetes under the name Mounjaro, but it’s likely to be approved for weight loss soon, reports Kaiser Health News.
However, health experts warn that it is still too early to say how effective the new drugs will be, especially for different patients. In addition, the high cost of these drugs — which can exceed $1,000 a month and are typically not covered by insurance — can limit access for many patients.
Proponents argue that insurers should cover weight-loss drugs similarly to treatments for cancer or chronic diseases. Currently, Medicare prohibits obesity drug coverage for “anorexia, weight loss, or weight gain,” although bariatric surgery will be paid for.
“There’s no denying that when you take medication, you can achieve significant weight loss — and reduce the complications of obesity,” said Timothy Garvey, a professor at the University of California the University of Alabama-Birmingham. “It’s going to be hard for health insurers and payers to deny that.”
However, some experts say the drugs may not be worth the cost and could increase healthcare spending.
“If you pay too much for a drug, everyone’s health insurance goes up. Then people cancel health insurance because they can’t afford it,” so making these weight-loss drugs available can actually negatively impact the healthcare system, David Rind said. CMO for the Institute for Clinical and Economic Evaluation.
Some patients seek off-label use of diabetes medications to lose weight
Another growing problem is the off-label use of diabetes drugs like Ozempic and Mounjaro for weight loss. Although doctors may, at their discretion, prescribe the drugs to overweight or obese people to help them lose weight, the drugs are also prescribed to some patients who do not meet these criteria.
“It’s the Hollywood drug,” said Patti Stanger, star and executive producer of reality show The Millionaire Matchmaker, who took Ozempic herself. “It’s national. I have friends in Miami, I have friends in New York who do it.”
“Everyone wants a quick fix,” said Lisa Moskovitz, a Registered Nutritionist and CEO of New York Nutrition Group. However, when people stop taking Ozempic, “they lose that feeling of fullness, that benefit of not being so hungry. And now your hunger signals and cues can become much stronger.”
Currently, the use of these drugs in relatively healthy people has not been studied and is not supported by any scientific evidence, writes The Wall Street Journal. Neither Ozempic nor Wegovy have been approved for people with chronic medical conditions and are not intended for occasional weight loss.
“From our standpoint, we do not encourage, propose or encourage off-label use at all,” said Jason Brett, executive director of medical affairs at Novo Nordisk. He also noted that the company “does not consider weight loss for cosmetic purposes or episodic weight loss for people who do not meet these criteria of FDA-approved indications.”
Although physicians are generally able to prescribe drugs for off-label use at their discretion, Chanapa Tantibanchachai, a spokesman for the FDA, said that “[i]It is important to note that FDA approval (or clearance) of a medical device for a particular use does not guarantee its safety and efficacy for other uses.”
That American Diabetes Association (ADA) and Mutual help in diabetes have both raised concerns about how off-label use of these drugs could create shortages and affect patients with diabetes. Robert Gabbay, ADA’s chief scientific and medical officer, said he’s 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)