FDA Approval of Zepbound® for Obstructive Sleep Apnea: A Game-Changer for Patients and a Potential "Backdoor" to Broader Medicare Coverage

Today, the FDA granted approval for Eli Lilly’s Zepbound® (tirzepatide) as the first and only prescription medication to treat moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity. While this groundbreaking approval highlights the dual benefits of Zepbound for both OSA and weight loss, it also signals a potential shift in how GLP-1 medications could gain traction in Medicare coverage under specific diagnoses.

Addressing More Than Snoring

Obstructive sleep apnea, often dismissed as “just snoring,” is a serious condition that impacts millions of Americans. Characterized by airway collapses during sleep, it can lead to fatigue, daytime sleepiness, and even more severe health complications like cardiovascular disease.

The SURMOUNT-OSA Phase 3 trial demonstrated that patients taking Zepbound experienced up to 25 fewer breathing interruptions per hour, with nearly half achieving remission or mild, non-symptomatic OSA within a year. Additionally, Zepbound's weight-loss effects were remarkable, with participants shedding up to 20% of their body weight.

“OSA is more than a sleep disorder—it’s a systemic condition with far-reaching consequences,” said Patrik Jonsson, Executive Vice President at Lilly. “Zepbound’s approval marks a critical advancement, reducing the dual burden of OSA and obesity.”

A Likely Pathway to Medicare Coverage

While this approval is a significant step forward, its implications for Medicare patients could be even more impactful. Currently, many Medicare plans do not cover GLP-1 medications for obesity alone, leaving millions without access. However, this new indication for OSA—classified as a medical condition rather than strictly a weight-loss issue—could open the door for broader Medicare coverage.

This scenario mirrors what we’ve seen with Novo Nordisk’s Wegovy®, which gained traction in some Medicare plans under its approval for reducing cardiovascular risks in patients with heart failure. Similarly, Medicare patients with an OSA diagnosis may now have a pathway to access Zepbound for their condition, with its weight-loss benefits serving as a secondary (but no less critical) outcome.

What This Means for Patients

For patients, this approval could spark a sea change in the availability of GLP-1 medications under insurance plans. By targeting specific medical conditions tied to obesity, manufacturers like Eli Lilly and Novo Nordisk are effectively leveraging these “backdoor” indications to make life-changing treatments more accessible.

Moreover, it raises the possibility of broader conversations between healthcare providers and patients about the interconnected nature of obesity and other health conditions like OSA, heart failure, and diabetes.

The Road Ahead

While the FDA approval of Zepbound for OSA is a monumental step, it also raises critical questions. Will Medicare swiftly adapt its policies to cover Zepbound for OSA patients, as it has for similar indications? Will this move spur further innovation in how insurers classify and cover obesity medications?

As these conversations unfold, one thing is clear: Zepbound’s new indication is more than a treatment—it’s a statement about the evolving landscape of obesity care.

Stay tuned to On The Pen for continued updates and analysis on the latest developments in weight loss and diabetes treatments. Sharing this article is a powerful form of advocacy that brings us closer to educating the masses and reducing the stigma of obesity. If you found this article insightful, please share it within your networks, especially in Facebook groups and Reddit forums dedicated to GLP-1 medications and diabetes management. Together, we can make a difference.