Medications such as Ozempic (semaglutide) and Mounjaro (tirzepatide) have helped many people living with type 2 diabetes successfully control their blood sugar levels — and have helped patients that do not respond to other diabetes treatments. Cigna Healthcare continues to work with clients and business partners to make these groundbreaking treatments available for diabetes patients who need them, as well as protect people who may be using these drugs for weight loss purposes.

“This is what is known as off-label use,” said Katy Wong, chief pharmacy officer at Cigna Healthcare. “While Ozempic and Mounjaro are known to cause significant weight loss for diabetes patients, they are actually not approved by the FDA as weight loss medications,” she said. “However, people ask their doctor to prescribe these drugs to help them lose weight — even though they do not have a diabetes diagnosis.”

The dramatic weight loss effects of Ozempic and Mounjaro led to these medications becoming social media sensations, touted as miracle drugs that have helped countless TikTok users and influencers lose weight. However, the now-widespread off-label use of these medications is creating problems for people living with diabetes. After Mounjaro’s weight-loss benefits were promoted recently through social media, the drug was in short supply for two months. For Ozempic, the shortage lasted for six months. While supplies have been increasing, both drugs remain on the FDA’s drug shortage database, suggesting that many diabetes patients may be struggling to obtain them, and may have serious health complications as a result. 

“When people use these drugs off-label for weight loss, it becomes more difficult for patients with diabetes to get the treatment they need,” Wong said.

Wong added that such off-label medication requests could lead to potential safety risks. Common side effects of Ozempic and Mounjaro include nausea, vomiting, and diarrhea. Rare but serious side effects include inflammation of the pancreas, low blood sugar, and problems with the kidneys and gallbladder. These two medications should not be taken by people with a personal or family history of medullary thyroid carcinoma, as well as those with a syndrome known as multiple endocrine neoplasia type 2.

Health plans ensure diabetes medication are reserved for those with diabetes

Many health plans protect patients against off-label use of Ozempic or Mounjaro to help control weight. For example, part of Cigna Healthcare’s coverage criteria for Ozempic requires that patients have been diagnosed with type 2 diabetes and have tried metformin without success, when appropriate. “It’s about ensuring medication access and promoting appropriate use,” Wong said.

Weight-loss medication can be effective for some people — but not for everyone, and not without support

Wong noted the FDA has approved weight-loss drugs such as Wegovy, Saxenda, Contrave, and Xenical for patients who do not have diabetes. These drugs work by making a person feel less hungry, more full, or both. Cigna Healthcare covers Wegovy and Saxenda on their drug formularies for clients who elect to cover weight loss medications in their benefit plan.

However, weight-loss medication may not be suitable for everyone. Most medications state that they should be used only when an individual’s body mass index (BMI) is above the range for healthy weight. “Healthy BMI numbers can be different from person to person,” Wong said, noting that factors such as ethnicity, age, sex, and muscle mass affect the relationship between BMI and body fat.

Certain weight-loss medications may have other stipulations for patients, such as having a serious weight-related health condition like cardiovascular disease, hypertension, or high LDL cholesterol.

Weight loss requires a comprehensive plan

People cannot successfully lose weight through medication alone. Dr. Mandeep Brar, a clinical endocrinologist and a medical director at Cigna Healthcare, says that losing weight and keeping it off can be a complex endeavor, which typically requires more than counting calories and regular exercise.

Effective plans for weight loss involve a multidisciplinary team, which typically includes the individual’s primary care doctor, a registered dietician, and preferably an endocrinologist and exercise physiologist, Dr. Brar said. “This ensures the person is fully counselled on proper nutrition, exercise, and behavior modification strategies that help achieve and maintain long-term weight loss and improve clinical outcomes,” she added.

Dr. Brar noted that for certain people, these plans may also include weight-loss medication with appropriate guidance and follow-up, including individualized tools and support to encourage medication adherence as well as healthy behaviors and habits. “For patients to achieve their weight management goals successfully and sustainably, medications like Wegovy could be part of a comprehensive care management plan to help people stay on track with their medication, while implementing the necessary lifestyle changes that will allow them to achieve meaningful weight loss,” she said.

Dr. Brar and Wong cautioned that medication should never be used as a substitute for the behavior and lifestyle adjustments needed to maintain a healthy weight.

“When a doctor does recommend the use of an approved weight-loss medication, people still need to commit to a lifelong weight-loss strategy — which may include eating healthier, balanced meals, being more physically active, improving sleep patterns, and other lifestyle modifications,” Dr. Brar said.