The demand for glucagon-like-peptide-1 (GLP-1) medications, used for both diabetes and weight loss, has surged significantly, showing no signs of slowing down. Anticipated new drugs in the GLP-1 category, along with additional indications for existing drugs, are expected to add 1% to the projected 9% increase in employer-sponsored healthcare costs for 2025, according to data released by Aon in August 2024.
Wegovy vs Zepbound: The Ultimate Showdown in Weight Loss Medications
Although many GLP-1 drugs have gained popularity in recent years, Zepbound is poised to become a leading medication in 2025. This is due to improved availability, a new treatment indication and positive head-to-head trial results. The first head-to-head trial comparing the popular GLP-1 weight loss medications, Zepbound and Wegovy, has shown that Zepbound users lost 47% more weight than those on Wegovy, according to Eli Lilly. This data reveals that, under identical trial conditions, Zepbound, which mimics two hormones, is more effective for weight loss than Wegovy, which has a single hormone mechanism of action. Currently, many doctors prescribe the drugs based on availability at the pharmacy due to intermittent supply shortages. These results may impact product selection more in the coming year as shortages improve.
Zepbound Pioneering a New Era in Sleep Apnea Treatment
On December 20, 2024, the FDA approved Zepbound as the first drug treatment option for obstructive sleep apnea (OSA). Zepbound is approved for treating moderate to severe OSA in adults with obesity, to be used in combination with a reduced-calorie diet and increased physical activity. OSA is a condition where a person's upper airway becomes blocked, leading to pauses in breathing during sleep. While it can affect anyone, OSA is more prevalent in individuals who are overweight or obese.
Similarly, Wegovy received a secondary indication in March 2024 to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight. As both of these expanded indications are related to the medications' weight loss outcomes, coverage still depends on a payer's decision to cover weight loss medications. In some instances, a plan may choose to allow coverage for the expanded indications only.
FDA's Removal of Tirzepatide from Shortage List Sparks Legal Battle
The Food and Drug Administration (FDA) announced the removal of tirzepatide (Zepbound/Mounjaro) from the shortage list in October 2024. This means compounded versions would no longer be allowed, as the FDA restricts compounding drugs that are commercially available. Following the announcement, the Outsourcing Facilities Association, a trade organization for compounding pharmacies, filed a lawsuit challenging the FDA’s decision. They claimed the decision was made without proper notice and disregarded evidence indicating that a shortage still persists. They argued that this action benefits Eli Lilly at the expense of the users.
On December 19, 2024, the FDA maintained its position but provided ample notice to compounding pharmacies and their users to make appropriate transitions. State-licensed 503A compounding pharmacies have been given 60 days, until February 18, 2025, to discontinue tirzepatide compounding. Outsourcing 503B compounding pharmacies have been given 90 days, until March 19, 2025. As of December 19, tirzepatide is the only GLP-1 product being removed from the FDA’s shortages list, while dulaglutide (Trulicity), semaglutide (Ozempic/Wegovy) and liraglutide (Victoza/Saxenda) remain listed as “in shortage.”
Victoza Goes Generic
As of June 2024, Teva launched its generic version of the diabetic GLP-1 medication Victoza, liraglutide. Teva was the authorized generic distributor for the initial six-month exclusivity period. By late December 2024, at least one additional generic distributor had launched their product, with more expected to follow. Liraglutide is currently listed as in shortage, but additional generic distributors should help reduce the supply deficit and drive lower prices through competition. The Teva product saw a 16% to 17% reduction in price. As a once-daily injection, Victoza relinquished significant market share in recent years to newer products like the once-weekly Ozempic, making it unlikely to substantially impact payer costs.
However, liraglutide, being one of only two available generic GLP-1 medications, could be a favorable option where cost has been a barrier in diabetes treatment. The FDA also approved a generic version of Byetta (exenatide), but its utilization has diminished in favor of newer agents like Victoza. The next expected generic GLP-1 would be Trulicity, with a patent expiring in 2027. For more popular drugs like Ozempic/Wegovy, patent expiration in the US isn’t expected until 2032, and for the recently launched Zepbound/Mounjaro, expiration isn’t set until 2039.
Sources:
- Bruce Japsen. "Lilly's Obesity Drug Zepbound To Be Key Health Cost Driver For 2025," Forbes, 2024.
- FDA News Release. "FDA Clarifies Policies for Compounders as National GLP-1 Supply Stabilizes," FDA, 2024.
- Eli Lily News Release. "Lilly's Zepbound (tirzepatide) Superior to Wegovy (semaglutide) in Head-to-Head Trial," Lily Investor Relations, 2024.
- Patrick Wingrove. "Lilly's Zepbound Tops Wegovy in Weight Loss Head-to-Head Trial," Reuters, 2024.
- Patrick Wingrove and Bhanvi Satija. "US FDA Says Lilly's Weight Loss Drug Shortage Resolved," Reuters, 2024.
- FDA News Release. "FDA Approves First Medication for Obstructive Sleep Apnea," FDA, 2024.
- FDA News Release. “FDA Approves First Generic Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes," FDA, 2024.
- Hikma News Release. “Hikma Receives FDA Approval and Launches Generic Version of Victoza," Hikma, 2024.
