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The Food and Drug Administration (FDA) has recently made an announcement that the shortage of Zepbound has been resolved. This news has major implications for both compounding pharmacies and patients who rely on off-brand versions of the medication.
One such patient is Willow Baillies, a 29-year-old human resources specialist from Milwaukee, Wisconsin. Willow has been dealing with chronic autoimmune issues and weight loss for years but has been unable to afford the blockbuster treatment Zepbound due to its high monthly cost of around $1,000, which is not covered by her insurance. In an effort to save money, Willow turned to a compounded, off-brand version of the active ingredient in Zepbound, tirzepatide.
Tirzepatide is also used in Mounjaro, Eli Lilly’s diabetes medication, and has gained immense popularity among patients. Willow stated that since starting the compounded tirzepatide in June, she has seen significant improvements in her autoimmune symptoms and has lost around 52 pounds. The monthly cost of the compounded version is approximately $350 for her.
However, with the FDA’s announcement that branded tirzepatide is now readily available, patients like Willow who rely on compounded versions may soon lose access to their medication. This could lead to some patients stockpiling doses, transitioning to alternative treatments, or even being forced to discontinue care due to financial constraints. It may also lead to patients attempting to mix vials independently, a potentially dangerous practice.
During shortages declared by the FDA, pharmacists are allowed to compound versions of brand-name medications, but these compounded medications are not FDA-approved. They are custom-made duplicates prescribed by a doctor to meet the specific needs of a patient. This has led to opposition from drugmakers and some health experts who argue that compounded medications lack the necessary oversight and quality control.
The FDA’s decision to end the shortage of tirzepatide is based on a comprehensive analysis of data and is expected to increase access to Zepbound for patients with insurance coverage after months of limited supply. It also signifies that Eli Lilly’s efforts to increase production of tirzepatide are beginning to show results. However, it will also mean the end of a niche market for compounded drugs like tirzepatide that have been vital for patients who cannot afford the branded version.
Despite the resolution of the shortage, some patients still report difficulty in locating Eli Lilly’s medications. This has raised concerns among medical professionals about the company’s ability to meet the demand for Zepbound, especially since it has recently been approved for the treatment of obstructive sleep apnea. As more patients transition from compounded versions of the medication to the branded version, the pressure on Eli Lilly to meet demand will only increase.
It is unclear how many patients are currently using compounded tirzepatide, but an estimate from a trade group suggests that a significant number of prescriptions for compounded versions of similar weight-loss drugs are being filled each month. The resolution of the shortage may lead to a decline in the availability of compounded versions, but it is unlikely that they will disappear entirely from the market.
The legal dispute between the FDA and the Outsourcing Facilities Association regarding the production of compounded tirzepatide is ongoing. While the FDA has extended the deadline for enforcement actions against compounding pharmacies, the situation remains uncertain. Pharmacies may still be allowed to produce compounded versions of the medication under certain circumstances, but the future of compounded tirzepatide in the United States is still up in the air.
In conclusion, the resolution of the Zepbound shortage has significant implications for patients and compounding pharmacies. While it may increase access to the branded medication for some patients, it could also limit options for those who rely on compounded versions. The ongoing legal dispute adds another layer of complexity to the situation, leaving many patients and providers uncertain about the future of tirzepatide.
