The Tirzepatide Shortage Is Over – Now What?
Late yesterday, FDA announced that Lilly’s tirzepatide shortage is officially over. Both Mounjaro and Zepbound are fully available in all marketed strengths and dosage forms.
“The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. Tirzepatide injection has been in shortage since 2022 due to increased demand.
“FDA confirmed with the drug’s manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand. Patients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.”
For now, the tirzepatide’s primary competitor, semaglutide, remains in short supply from Novo Nordisk. Two other GLP-1s, liraglutide and dulaglutide, are also still in a state of shortage.
Is the Compounding Party Over?
This may well mean a quick end to any large-scale compounding for tirzepatide. In their statement yesterday, FDA reminded compounders of legal restrictions against making copies of an FDA-approved drug when the supply is adequate from its primary source. In a statement yesterday, the Alliance for Pharmacy Compounding said pharmacies must immediately cease preparing and dispensing compounded copies of Mounjaro and Zepbound. CEO Scott Brunner described this as a mixed blessing:
“For Lilly, this is surely progress, but for many patients, at least in the near term, I’m not so sure. I suspect plenty of patients taking compounded tirzepatide are going to be caught flat-footed by this. They are being cut-off cold-turkey, their prescription no longer fillable. They’ll need to get in to see their provider to get a new prescription, and that will take some time. It’s possible that so many patients presently taking compounded GLP1s will be eventually switched to the FDA-approved versions – if they can afford them, of course – that it will push tirzepatide injection back into shortage. We’ll see.”
Supply, Demand, Price, and Competition
In truth, this is only one step in a long journey toward an equilibrium of supply, demand, and price for this remarkable new class of drugs. But it is an important one. That’s because it demonstrates that Lilly is committed to getting past a price skimming strategy that makes life-changing new obesity medicines available to only a small sliver of the population that needs them.
When supply and competition are constrained, prices stay high. Lilly seems to be opening up the supply at the same time it is signaling readiness to improve the affordability of its drug.
After listening to the Novo Nordisk CEO trying to deflect questions in a Senate hearing last week about prices for its related drugs – Ozempic and Wegovy – it is not clear how that company will respond to pricing and supply moves from Lilly.
Changes Ahead
One thing is clear. Changes are coming to the economic and social environment for obesity care. ConscienHealth’s Ted Kyle described some of this for Business Insider recently:
“It’s going to be really messy but five years from now, prices will more reasonable, access much better, and more people will be getting care with a whole lot less blame and shame.”
Will Novo be content to keep skimming profits with a very tight supply? Competition – already intense – will only increase. Complacency is a good way to lose a position of market leadership. It could be costly to Novo Nordisk.
Click here, here, and here for more on the resolution of tirzepatide shortages.
Window Opened to the Street Penthieure, painting by Pablo Picasso / WikiArt
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October 3, 2024