November 11 FDA Approves New Weight Loss Drug, Zepbound
On November 8, 2023 the FDA approved a new medication for weight loss that could impact the roughly 40% of Americans with obesity today. Tirzepatide, currently on the market under the trade name, Mounjaro, for type 2 diabetes will now be available for weight loss at a higher concentration under the trade name, Zepbound. Tirzepatide is part of a class of medications known as GLP-1 agonists that have skyrocketed in popularity in recent years. It works by mimicking one hormone that helps reduce food cravings, as well as a second hormone that may also improve how the body breaks down sugar and fat, helping to amplify the weight loss effects.
This newest FDA approval comes as no surprise and is the latest product to join its competition following the same logic. Semaglutide, is currently on the market under the brand name, Ozempic, for diabetes and is available in a higher strength under the brand name, Wegovy, for weight loss.
Like Wegovy, Zepbound is a once weekly self-administered injection and is recommended in addition to a reduced caloric diet and increased exercise. Side effects with these medications are mainly gastrointestinal issues such as nausea, vomiting, constipation and diarrhea. In clinical trials, the highest dose of Zepbound led to an average weight loss of over 22% of body weight, more than the 15% average weight loss seen with Wegovy.
Zepbound is expected to be available in the U.S. after Thanksgiving in six doses at a list price of about approximately $1,060, which is about 20% lower than Wegovy. Lilly, the drug’s manufacturer, said it would offer a savings card for patients with commercial insurance to get the drug for $25 for a one or three-month supply, if the patients’ insurance plan covers the medication. If the patients’ insurance does not cover Zepbound, the savings card would allow them to pay $550 for a one-month prescription.
So, what does this new approval mean for your clients? Clients that don’t currently cover weight loss products won’t be impacted by this approval. The prior authorizations will still be in place that require a diagnosis of type 2 diabetes for Mounjaro and that will not change. If anything, the buzz around this new drug may cause extra pressure from employees to cover weight loss medications. For those groups that currently cover weight loss products, this will affect them and plan spend will likely rise as a result of this latest approval. We would expect to see Zepbound hit PBM formularies in approximately 6 months pending evaluation by Pharmacy and Therapeutics (P&T) committee.