Ongoing shortages of popular weight loss and diabetes medications in the U.S. have ignited fierce competition among established pharmaceutical companies and a burgeoning market of compounded alternatives. Telehealth companies are eager to capitalize on this rapidly expanding industry.
Rising Demand for GLP-1 Medications
GLP-1 medications such as Ozempic and Mounjaro have surged in popularity due to their effectiveness in promoting weight loss. According to the health policy nonprofit KFF, approximately 1 in 8 U.S. adults have used a GLP-1 medication.
This increasing demand has led to multi-year shortages of drugs containing semaglutide and tirzepatide, the active ingredients in Ozempic and Mounjaro, respectively. When these medications are in short supply, compounding pharmacies can step in to provide alternative versions, ensuring patients continue to receive care.
The Role of Telehealth Companies
Major telehealth companies, including Hims & Hers and Noom, are taking full advantage of the current market situation. Jaime Almandoz, medical director of the University of Texas Southwestern Medical Center’s Weight Wellness Program, noted, “There’s never been such a demand, or a mismatch between branded supply and demand, that has driven this kind of explosion in compounding pharmacies and online platforms.”
While some pharmaceutical companies have launched legal actions against those providing compounded semaglutide products, both Hims & Hers and Noom have yet to face lawsuits from these manufacturers.
Regulatory Challenges and Concerns
Compounded drugs are not identical to their FDA-approved counterparts. Although compounding pharmacies are regulated by the FDA, their products lack FDA approval. Typically, compounding pharmacies create modified medications for patients unable to use the standard formulations due to allergies or other reasons.
There are two types of compounding pharmacies: 503A facilities, which create drugs tailored to specific prescriptions, and 503B facilities, which can produce larger batches for distribution. The latter are subject to stricter regulations.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding (APC), emphasized that compounded GLP-1s are not mere substitutes for FDA-approved versions. Prescriptions for compounded semaglutide must be explicitly written for that purpose.
Legal Actions from Big Pharma
Pharmaceutical giants like Novo Nordisk and Eli Lilly have initiated legal battles against companies offering compounded alternatives. Novo Nordisk has filed lawsuits against 40 pharmacies, spas, and clinics for distributing “copycat” drugs, claiming they may be contaminated or substandard. Eli Lilly has also launched six lawsuits against similar entities, expressing concerns about the safety of these products.
Cost Comparison of Compounded Drugs
Both Hims & Hers and Noom confirmed they source their compounded semaglutide from 503B facilities. While they do not accept insurance for these products, their prices are significantly lower than those of brand-name medications. For instance, Noom’s compounded semaglutide ranges from $149 to $279 per month, while a month’s supply of Ozempic can cost approximately $1,000, though insurance and manufacturer coupons can reduce out-of-pocket expenses.
Noom’s CEO, Geoff Cook, pointed out that the pricing of compounded semaglutide is more in line with what is seen in many other countries, highlighting the stark difference in U.S. pricing.
Future of Compounded Medications
The landscape surrounding compounded drugs hinges on the ongoing shortages of Ozempic and Mounjaro. While telehealth companies are optimistic about their future, noting potential expansions in their product offerings, there is uncertainty regarding the implications if the FDA resolves the shortage.
Almandoz raised concerns about the sourcing of semaglutide for compounded medications. “These are complex chemicals. What is the actual supply?” he questioned, emphasizing that these are on-patent drugs that are not simple to manufacture.
Physician Concerns Regarding Compounded Medications
Given the influx of patients seeking GLP-1 medications, Almandoz and other obesity specialists prefer not to prescribe compounded options when FDA-approved medications are available. He noted that professional organizations recommend against prescribing compounded versions under such circumstances due to potential risks, including overdoses linked to miscalculations in self-administered doses.
Almandoz added that while telehealth platforms may provide some level of medical supervision, it often lacks meaningful engagement, raising concerns about patient outcomes.
Conclusion
The ongoing shortage of weight loss drugs has led to an explosive market for compounded alternatives. As competition heats up between established pharmaceutical companies and new telehealth platforms, questions about safety, sourcing, and regulation remain paramount for both patients and healthcare providers.
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