ECRI Blog

Glucagon-like peptide receptor agonists (GLP-1 RAs) now available to promote weight loss—Wegovy (semaglutide), Zepbound (tirzepatide), and Saxenda (liraglutide)—could potentially make much needed gains against the obesity epidemic; however, the benefits of these medications come at a significant financial cost to patients and payors and the risk of rare but serious adverse events. Making sure the medications reach the right patients—those most likely to derive long-term benefits with low risk—will be critical to make the most of GLP-1 RAs. Prescribers will lead that effort by identifying and recruiting eligible patients, which is a difficult task because obesity is a complex disease; therefore, prescribing information will need to be interpreted in the context of each patient’s unique characteristics and circumstances. Furthermore, old and new misconceptions about obesity and weight loss drugs—now amplified and reinforced by social trends and media—can predispose patients and make discussions with physicians difficult.

Roughly one year after their introduction, Wegovy (semaglutide) and Zepbound (tirzepatide) continue to shake up the obesity treatment landscape in the United States. Uptake for these two glucagon-like peptide receptor agonists (GLP-1 RAs) has surpassed expectations and is driving demand for Saxenda (liraglutide), an older GLP-1 also indicated for weight loss, along with off-label use of Ozempic (semaglutide) and Mounjaro (tirzepatide), two GLP-1 formulations indicated for treating diabetes. The reason for this is clear: a large body of clinical evidence shows the drugs can help patients lose 15% to 25% additional weight when used alongside evidence-based lifestyle interventions (counseling, diet, and exercise). These effects are greater than those seen with older weight loss medications (typically ~5% total weight loss) and close to typical weight loss seen with bariatric surgery.

The prevalence of overweight and obesity keeps worsening in America despite our enormous collective effort to lose weight. The U.S. Centers for Disease Control and Prevention estimates that overweight and obesity now affect over 70% of Americans and add over $170 billion to annual U.S. healthcare costs. About half of Americans try to lose weight each year, and social trends constantly shift around a myriad of weight loss interventions and products. Among these, weight-loss-inducing medications have historically received limited attention. However, public interest and demand for weight loss drugs has spiked since the introduction of two new drugs: semaglutide (Wegovy) in 2022 and tirzepatide (Zepbound) in 2023. 

In the last two decades, the number of commercially available genetic tests is thought to have increased by more than 5,000%—from approximately 1,500 to an estimated 100,000 or more. This number only increases daily as US-based, Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories commercialize new tests through the laboratory-developed test (LDT) pathway. LDTs are specialized tests performed only by certain labs and are regulated by Medicare through CLIA. This pathway, which is largely exempt from FDA premarket review, permits tests to come to market quickly and with little regulatory oversight. 

The LDT pathway can be problematic because it does not require evidence from laboratories to support test claims. FDA previously identified problems with high-risk LDTs, ranging from a lack of appropriate controls yielding erroneous results to outright falsification of data. This makes it difficult for payers to know which tests to cover and for clinicians to know which tests are likely to help patients.  

When compared to ten other developed nations, the United States has the highest maternal death rate. Yet, according to a recent maternal mortality review committee report by the Centers for Disease Control and Prevention, 84% of pregnancy-related deaths are preventable. This maternal health crisis has been shaped, in part, by socioeconomic inequities and inconsistent insurance coverage policies, which limit healthcare access by underserved populations. So what tools are available now to help reduce preventable harm among childbearing women? Clinical evidence suggests that telehealth could be one solution.