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An injection pen for Zepbound, Eli Lilly’s weight loss medication, was showcased in New York City on December 11, 2023.
The steep monthly cost of approximately $1,000 for Eli Lilly’s weight loss drug Zepbound has placed this highly regarded treatment out of reach for many patients, including 29-year-old Willow Baillies, whose insurance does not cover the drug.
Located in Milwaukee, Wisconsin, Baillies has been on a weight loss journey while managing chronic autoimmune conditions for several years. In search of a more affordable option, she opted for a compounded, off-brand version of tirzepatide, the active ingredient in both Zepbound and Eli Lilly’s diabetes drug, Mounjaro, both of which belong to the popular class of medications known as GLP-1s.
Since beginning treatment with the compounded form of tirzepatide in June, Baillies reports significant improvements in her health, losing around 52 pounds and alleviating some of the pain associated with her autoimmune issues. This compounded version costs her roughly $350 per month.
However, recent news indicates that Baillies and similar patients may soon face challenges accessing compounded tirzepatide. Healthcare professionals and patients have expressed concerns that the FDA’s recent announcement—indicating that branded tirzepatide is no longer in short supply—may limit the availability of these more affordable alternatives from compounding pharmacies in the coming months. As a result, many patients may feel compelled to stockpile their medications, switch to less effective treatments, or cease their weight management efforts altogether due to financial pressures. Others might resort to potentially dangerous methods, such as mixing vials themselves.
The FDA’s announcement suggests that Eli Lilly’s extensive manufacturing enhancements are yielding results, which may allow more insured patients to access Zepbound following months of constrained supply. Nevertheless, this decision may eliminate a critical resource for those who previously relied on compounded versions to bridge the affordability gap left by insurance policies that often exclude weight loss medications.
Despite the FDA’s declaration, numerous insurance plans continue to exclude coverage for weight loss drugs, leaving some patients like Baillies to grapple with the high costs of medications, even those offered through Eli Lilly’s savings programs.
“I have stockpiled 10 compounded vials at home, ensuring I have at least a year’s supply,” Baillies stated in an interview. “We would go to great lengths to maintain this medication. It’s not just about aesthetics; it profoundly affects our quality of life.”
There remains skepticism among patients and health organizations regarding whether the claimed shortage resolution is genuinely effective, as many report ongoing challenges in accessing Eli Lilly’s drugs. Healthcare professionals are also concerned about the company’s ability to meet future demand, especially if a surge of patients shifts away from compounded therapies, compounded by the recent approval of Zepbound for treating obstructive sleep apnea.
While precise figures regarding patients using compounded tirzepatide remain unclear, one trade group estimates that over 200,000 prescriptions for compounded versions of Wegovy, a competitor weight-loss drug, are filled monthly.
“At this moment, I believe the shortage is resolved,” said Dr. Shauna Levy, an obesity medicine expert and medical director at the Tulane Bariatric Center in New Orleans. “However, I doubt this resolution will be permanent.”
Eli Lilly did not reply immediately to inquiries regarding this situation.
Regulatory Challenges and Timeframes
Previously, the FDA announced in October that the tirzepatide shortage was over. Soon after, however, the Outsourcing Facilities Association filed a lawsuit, claiming that the agency’s decision was made without adequate notice or consideration of ongoing supply challenges. This legal action prompted the FDA to reassess its position, allowing compounding pharmacies to continue producing the drug.
In its latest ruling, the FDA assessed various data sources, concluding that Eli Lilly’s supply is currently adequate to meet demand. The FDA is permitting 503A compounding pharmacies until February 18 to continue operations before enforcement actions may take effect. Compounding pharmacies categorized as 503B outsourcing facilities are granted an additional month, with a deadline of March 19.
Trade group members welcomed this extension, stating that it enables patients to switch back to branded tirzepatide gradually. However, challenges persist, with reports indicating a continuing lack of availability for the drug. As such, compounding pharmacies might still be permitted to produce specialized compounded tirzepatide under specific circumstances if a patient’s physician determines that variations will create a “significant difference” in patient outcomes.
Nonetheless, industry representatives caution that the overall scale of compounded tirzepatide will likely diminish as regulations tighten. The ongoing legal dispute between the FDA and the Outsourcing Facilities Association remains unresolved, with updates regarding litigation expected by January 2.
Seeking Alternative Solutions
Patients dependent on compounded tirzepatide are urgently evaluating their options. For example, Amanda Bonello, 36, from Iowa, who is prediabetic, reports that using the compounded injectable has helped her lose 26 pounds and stabilize her blood sugar levels. She notes that she cannot afford the brand-name drug since her insurance does not cover it, prompting her to consider switching to compounded semaglutide, another GLP-1 medication still experiencing shortages.
Bonello has initiated a petition advocating for FDA support of compounded GLP-1 access, which has garnered significant attention, accumulating over 15,000 signatures in a month.
Another patient, Erin Hunt, 31, based in Maryland, has also been utilizing compounded tirzepatide after initial difficulties obtaining Zepbound. She has reported a weight loss of about 55 pounds, alongside a noticeable reduction in symptoms related to her chronic inflammatory conditions. Hunt has expressed concerns regarding the costs of future medications, as her insurance does not cover Zepbound, and she has previously been able to purchase compounded tirzepatide for $300 to $350 monthly.
Jill Skala, a 49-year-old teacher in Pennsylvania, is bracing for the loss of her more affordable option, as her insurance will no longer cover Zepbound starting January 1. She has experienced significant physical and mental health improvements during her treatment, and with a stockpile prepared, she is uncertain about her options moving forward should she exhaust her supply.
Some individuals are contemplating engaging with unregulated online resources, often dubbed the “gray market,” to secure injectable peptides at considerably lower prices. This approach can involve purchasing powdered tirzepatide or semaglutide peptides from unverified sellers, creating a high-risk scenario that could involve unsafe mixing practices.
Dr. Levy has expressed severe concerns regarding the safety of these unregulated alternatives, stressing that improvised mixing of medications can have dire repercussions. She emphasizes the need for systemic changes in insurance coverage to address the growing demand for obesity treatments effectively.
Navigating Patient Care
Some compounding pharmacies, such as Strive Pharmacy, are continuing their operations while awaiting further legal developments. Strive operates a network of nine pharmacies across the U.S., providing compounded GLP-1 medications among other services.
Despite their willingness to accommodate individual prescriptions for specialized patient needs, Strive’s pharmacy chief noted that the looming regulatory deadline may force them to cease producing compounded tirzepatide altogether.
In a related case, Gina Wright, 58, who plans to initiate compounded tirzepatide with specific enhancements for her health needs, reflects the plight of many patients navigating these changes. Wright, uninsured for Zepbound, is exploring ways to get coverage based on her dual health conditions, including sleep apnea.
The ability to provide safe and effective compounded medications may become increasingly challenging as the regulatory landscape shifts and pharmacies must adapt to meet both patient needs and legal compliance.
The American Diabetes Association currently advises against the use of compounded GLP-1 alternatives due to existing concerns about their safety, quality, and efficacy. The organization has cited instances of adverse reactions stemming from incorrect dosing practices as a motivation for caution.
Despite the challenges they face, many patients like Molly B.—who has successfully lost weight and managed her health with compounded medications—remain hopeful for continued access to these options. For her, compounded tirzepatide has become a crucial part of her health journey after repeated denials for branded alternatives by her insurance provider.
“For the first time, I’m seeing real results, while in the past, I struggled endlessly without success,” she shared. “I sincerely hope to maintain access to this treatment.”
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