The recent announcement by the Food and Drug Administration (FDA) that the Zepbound shortage has been resolved has significant implications for compounding pharmacies and patients who rely on off-brand versions of the popular drug. This news has sparked mixed reactions among individuals like Willow Baillies, a 29-year-old human resources specialist from Milwaukee, Wisconsin, who had been unable to access Zepbound due to its high cost.
Baillies, who has been struggling with chronic autoimmune issues and weight loss, found relief in a compounded, off-brand version of tirzepatide, the active ingredient in Zepbound and Mounjaro, Eli Lilly’s diabetes counterpart. She noted that since she began taking the compounded tirzepatide in June, she has experienced a significant improvement in her health, losing approximately 52 pounds and reducing autoimmune-related discomfort. The monthly cost of the compounded medication amounts to around $350, a more affordable alternative compared to the $1,000 monthly cost of Zepbound.
However, with the FDA’s recent announcement that branded tirzepatide is no longer in limited supply, compounding pharmacies may no longer be able to produce and distribute cheaper versions of the drug. This decision poses a challenge for patients like Baillies, who rely on compounded medications due to financial constraints. Without access to these compounded versions, patients may be forced to stockpile doses, switch to alternative treatments, or discontinue care altogether. Some may even resort to potentially dangerous practices like mixing vials independently.
While the FDA’s decision aims to ensure greater access to Zepbound for patients with insurance coverage and signifies progress in Eli Lilly’s efforts to increase production of tirzepatide, it also creates a dilemma for those who have benefited from compounded versions of the drug. Patients like Baillies have reported that the prices of Eli Lilly’s savings programs and half-priced vials are still prohibitively high, particularly since weight loss medications are often not covered by insurance plans.
As patients and healthcare professionals grapple with the implications of the FDA’s decision, there are concerns about the sustainability of Eli Lilly’s supply of Zepbound and the possible impact on patients transitioning from compounded tirzepatide. The exact number of individuals using compounded versions of tirzepatide is unclear, but it is estimated that over 200,000 prescriptions of compounded weight-loss medications are filled each month.
Dr. Shauna Levy, an expert in obesity medicine, expressed confidence that the shortage of tirzepatide has been resolved for now but remains skeptical of a permanent solution. The ongoing legal dispute between the FDA and the Outsourcing Facilities Association further adds to the uncertainty surrounding the availability of compounded tirzepatide in the future.
Compounding pharmacies, particularly 503A pharmacies that customize medications for individual patients, face impending deadlines for compliance with FDA regulations. While 503B outsourcing facilities have been granted an extension, the fate of compounded tirzepatide remains uncertain pending the resolution of the legal dispute between the FDA and the Outsourcing Facilities Association.
As patients, healthcare professionals, and compounding pharmacies await further updates on the status of tirzepatide, there is a sense of unease regarding access to affordable alternatives to Zepbound. The outcome of the ongoing legal dispute and the enforcement actions against compounding pharmacies will greatly impact patients who rely on compounded medications for their health and well-being.
