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The Food and Drug Administration (FDA) has recently announced that the shortage of Zepbound has been resolved, which will have significant 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. Baillies has been dealing with chronic autoimmune issues and weight loss for years, but due to the high cost of Zepbound – approximately $1,000 per month – her insurance does not cover it. As a result, she turned to a compounded, off-brand version of tirzepatide, the active ingredient in Zepbound and Mounjaro, Eli Lilly’s diabetes medication.
Since starting the compounded tirzepatide in June, Baillies has seen a significant improvement in her autoimmune-related symptoms and has lost approximately 52 pounds. The monthly cost of the compounded medication is around $350, which is much more affordable for her compared to the branded version.
However, with the FDA declaring that branded tirzepatide is no longer in limited supply, compounding pharmacies will no longer be able to produce and distribute cheaper off-brand versions of the drug. This decision could potentially leave patients like Baillies without access to the medication they have come to rely on, forcing them to stockpile doses, switch to alternative treatments, or even discontinue care altogether due to financial constraints. Some may even resort to mixing vials independently, which can be dangerous.
Compounded medications are custom-made duplicates of brand-name drugs prescribed by a doctor to meet specific patient needs. The FDA does not approve compounded medications, which has led to opposition from drugmakers and some health experts. However, during declared shortages, pharmacists are allowed to produce compounded versions of brand-name medications to meet patient demand.
The FDA’s decision to end the shortage of tirzepatide is based on a thorough analysis of data and is expected to make Zepbound more accessible to patients with insurance coverage. This also signifies that Eli Lilly’s efforts to increase production of tirzepatide are starting to yield results. However, it also means the closure of a niche market for compounded tirzepatide that has been invaluable for patients who cannot afford the branded version.
While Eli Lilly offers savings programs and half-priced vial versions of the medication, some patients still find the prices to be prohibitively high. Additionally, there are insurance plans that do not cover pharmaceuticals for weight loss, further limiting access to the medication for certain patients.
Baillies, like many others who depend on tirzepatide, has stockpiled a year’s supply of the compounded medication at home. She is willing to go to great lengths to continue taking the medication that has improved her quality of life significantly. The resolution of the Zepbound shortage has sparked debate among patients, healthcare professionals, and trade groups, as some patients are still having trouble finding Eli Lilly’s medications.
Some medical professionals are concerned about Eli Lilly’s ability to meet the increased demand for Zepbound, especially as more patients transition from compounded tirzepatide to the branded version. The true impact of the shortage resolution remains to be seen, but it is clear that there are still challenges ahead for both patients and pharmacies.
The legal dispute between the FDA and the Outsourcing Facilities Association regarding the production of compounded tirzepatide is ongoing, adding to the uncertainty surrounding the availability of the medication. The FDA has extended enforcement action deadlines for compounding pharmacies, allowing them more time to comply with regulations.
While the future of compounded tirzepatide in the United States remains uncertain, it is clear that the resolution of the Zepbound shortage will have far-reaching consequences for patients and pharmacies alike. As the situation continues to evolve, it is important for all stakeholders to work together to ensure that patients have access to the medications they need to improve their health and quality of life.
