Expanding Coverage for FDA-Approved GLP-1s Is Critical for Patient Safety

(NewsUSA) - The newest generation of GLP-1 drugs has delivered life-changing benefits to patients managing diabetes, obesity, heart disease, and other chronic health conditions. And yet even though tens of thousands of lives would be saved each year by expanding access to GLP-1s, many insurers have declined to provide comprehensive coverage.

As a result, some patients have gambled with their health – likely unknowingly – by turning to compounded versions that are both risky and potentially less effective. These compounded GLP-1s—which are never approved by the U.S. Food and Drug Administration (FDA) and do not undergo their gold standard review for safety, effectiveness, or quality—come from loosely regulated pharmacies that don’t have to follow the same manufacturing standards. It’s a combination that can lead to catastrophic harm. As one example, in 2012, a fungal meningitis outbreak linked to a New England-based compounder killed more than 100 people and sickened over 700 others across 20 states. It’s no wonder why FDA has repeatedly warned that compounded products can have “potentially serious health risks.”

Fortunately, the clock has run out on those risky copycats. The FDA has declared that both semaglutide and tirzepatide—the active ingredients in Wegovy and Ozempic, and Mounjaro and Zepbound, respectively—are no longer in shortage, which had created a loophole for compounders to produce them. A federal court recently declined to issue an injunction blocking the FDA’s tirzepatide decision. The effect of those decisions is to put a halt to the continued manufacture and sale of these substandard drugs.

Efforts should now shift to helping increase access to FDA-approved GLP-1 drugs. As GLP-1 medicines continue to grow in popularity, expanded insurance coverage is critically needed to ensure that patients have access to safe and effective treatments. Patients living with obesity deserve access to FDA-approved treatments just like patients with diabetes or heart disease. There’s no reason why they should be denied insurance coverage for proven medicines like GLP-1s.

Manufacturers have launched programs to help make FDA-approved GLP-1s more affordable for patients who must pay out of pocket—but that’s just a start. To truly improve access, obesity has to be treated like every other chronic disease. And that means increasing government and commercial insurance coverage. 

Unsurprisingly, some insurers claim that the cost of GLP-1s is too high. That’s a shortsighted view. Given the current obesity public health crisis, covering these drugs now will not only help improve the lives of millions living with obesity but will also help reduce the prevalence and health care spending on the many costly conditions associated with it, such as diabetes, hypertension, heart disease, and liver disease, among others. Robust coverage may also help more people join or return to the workforce and ultimately save billions in lost productivity.

Tens of millions of Americans are living with obesity and they deserve access to proven FDA-approved treatments—they should not have to settle for substandard alternatives. With the GLP-1 shortage resolved, policymakers need to focus on increasing GLP-1 insurance coverage so patients who need help managing chronic health conditions can access safe and effective FDA-approved GLP-1 medicines.