Ozempic approved for Chronic Kidney Disease
The FDA has approved Semaglutide for chronic kidney disease. We explore research and the possible implications for insurance coverage and more.
While news of the benefits (and possible benefits) of GLP1 Receptor Agonists travels fast, regulatory bodies such as the FDA move slowly.
Check out our quick explainer
The FDA's job is to move slowly and carefully, and they've finally reached a decision on GLP1 (in this case Semaglutide, a formulation created by Novo Nordisk) and it's effectiveness in treating kidney disease for people with Type 2 diabetes:
That said, Ozempic's benefits related to treating maladies that come with type 2 diabetes are not unexpected – it's an excellent type 2 diabetes drug for a reason.
While there hasn't been an official FDA announcement yet (the incoming administration is undergoing a modernization effort that started in 2024), it's great to see this endorsement of GLP1s as a class of drugs.
How do we know Ozempic and GLP1s broadly help with Kidney Disease?
There's been some research that we covered mid last year:
GLP1.Guide Staff
Peter Rossing
There was reason to be skeptical of the Novo Nordisk funded 2024 study, but it's great to see that they were doing pioneering research rather than just playing into biases.
While it's been clear that there are numerous benefits to using GLP1 Receptor Agonists, the preponderance of peer-reviewed research on the topic finally encouraged the FDA to move towards approval.
Will insurance companies be more likely to cover GLP1s?
As more and more benefits of GLP1s emerge, one of the most important things to watch as benefits of GLP1s are recognized and covered by insurance companies.
Currently, there's no sign of a significant change in stance of insurance companies towards GLP1 drugs – they are still doing all in their power to avoid covering the drugs.
What most hope for here is that the need to cover treatments to kidney disease compels insurance companies to cover (and seek discounts on) GLP1 based remedies, but there is still resistance to offer GLP1s. Some insurers cover GLP1s however, for example Aetna:
Even companies like Aetna speak of formulary support rather than outright name brand support for names like Ozempic and Wegovy due to cost.
Even just receiving prescriptions remains unreasonably hard – many people employ the work-around of tele-health to receive prescriptions for Ozempic, Mounjaro and others – it looks like this will be necessary for some time to come.
How will this change affect the Semaglutide Shortage?
Semaglutide is still in shortage. The FDA approval is only likely to increase demand which might keep it in shortage longer than affected. Though high demand does not imply high purchasability – many people still cannot afford the drug due to it's high price without insurance coverage.
On that front, there's been some movement lately, with Novo Nordisk making forward-looking statements regarding "good news" related to Wegovy and Ozempic shortages ending soon:
There has even been a website set up to update the public (more likely investors) with regards to the shortage:
While the shortage ending should imply lower prices, it is clear that companies like Novo Nordisk and Eli Lilly do not want them to end for that purpose. It remains to be seen whether this will turn out to be consumer positive or not.
