A turning point for weight management benefits

It’s official: following October’s resolution of the shortage of Eli Lilly’s tirzepatide — also known by its brand names Zepbound and Mounjaro, the FDA in late February officially declared an end to the supply squeeze on GLP-1 semaglutide, which is also branded as Ozempic and Wegovy.

The supply update likely spells the end of widespread GLP-1 compounding in the U.S., which became an immensely popular avenue for patients to access weight loss drugs while the branded products were in shortage.

We should note that the Outsourcing Facilities Association, a compounding group, filed a lawsuit against the FDA right after its announcement, the outcome of which we’re yet to see.

Currently, U.S. regulations allow companies to offer compounded versions of drugs only when the brand-name versions are in short supply. Since GLP-1 drugs have been in shortage since 2022, several companies such as Hims & Hers, Ro, and WeightWatchers have offered compounded versions of the drugs. 

However, with GLP-1 drugs no longer in shortage, many of these companies will soon be unable to sell the current compounded versions. FDA has given these companies a facility-dependent grace period of 60 to 90 days to stop selling compounded GLP-1 drugs before the agency takes enforcement action, aiming to avoid unnecessary disruptions in patient care.

The 60-day deadline applies to compounding pharmacies who will no longer be able to sell compounded semaglutide after April 22nd, while after mid-May, patients who have been using compounded semaglutide will need to transition to other treatment options, such as Ozempic, Wegovy, or alternative weight loss treatments.

So what does this mean for the roughly one-third of employers who are already covering GLP-1s as part of their healthcare benefits, and those considering covering them? And the people whose treatment is at risk of being disrupted, or at least made more expensive?

Watch the full recording of our recent webinar to find out more.

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