The Food and Drug Administration (FDA) has recently announced that the shortage of Zepbound has been resolved, which has implications for both compounding pharmacies and patients who rely on off-brand versions of this medication. One such patient is Willow Baillies, a 29-year-old human resources specialist from Milwaukee, Wisconsin, who was unable to access Zepbound due to its high cost and lack of insurance coverage. 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.
Baillies has experienced significant improvements in her health since starting the compounded tirzepatide in June, with reduced autoimmune-related discomfort and a weight loss of 52 pounds. The monthly cost of this compounded medication is around $350, a much more affordable option compared to the $1,000 price tag for Zepbound.
However, with the FDA’s announcement that the branded version of tirzepatide is no longer in limited supply, patients like Baillies may soon lose access to compounded versions of the medication. This could force patients to stockpile doses, switch to alternative treatments, or even discontinue care altogether due to financial constraints. Some may even resort to mixing vials independently, a dangerous practice.
Compounded medications are custom-made duplicates of brand-name drugs prescribed to meet the specific needs of individual patients. During FDA-declared shortages, pharmacists are allowed to produce compounded versions of these medications. However, the FDA does not approve these medications, leading to opposition from drugmakers and some health experts.
The FDA’s decision to end the shortage of Zepbound will likely allow more patients with insurance coverage to access the medication after months of limited supply. Additionally, it reflects Eli Lilly’s efforts to increase production to meet demand for tirzepatide, especially as the drug is now approved for the treatment of obstructive sleep apnea.
Despite this positive development, some patients have raised concerns about the high prices of Eli Lilly’s savings program and the lack of insurance coverage for weight-loss medications. Baillies, along with other patients, has accumulated a year’s supply of compounded tirzepatide, showing the lengths patients will go to in order to access affordable treatment.
There are conflicting reports regarding the resolution of the shortage, with some patients still experiencing difficulties in obtaining Eli Lilly’s medications. This has led to apprehension among medical professionals about Eli Lilly’s ability to meet the demand for Zepbound as patients transition from compounded tirzepatide.
Currently, it is unknown how many patients are taking compounded tirzepatide, but estimates suggest that a significant number rely on compounded versions of similar medications each month. While some patients may still have access to compounded tirzepatide under specific circumstances, its prevalence in the United States is expected to decline.
The legal dispute between the FDA and the Outsourcing Facilities Association regarding the production of compounded tirzepatide is ongoing, further adding to uncertainty surrounding the availability of these medications. Pharmacies that produce compounded medications, particularly those considered 503A pharmacies, may still be able to manufacture tirzepatide in certain cases.
The FDA has extended deadlines for enforcement actions against compounding pharmacies in light of this ongoing legal battle. However, the ultimate fate of compounded tirzepatide remains uncertain until the dispute is resolved in court.
In conclusion, the resolution of the Zepbound shortage has significant implications for both patients and compounding pharmacies. While some patients may benefit from increased access to the branded medication, others face challenges in maintaining their current treatment regimens. The outcome of the legal dispute will have lasting effects on the availability of compounded tirzepatide and the options available to patients in need.
