News/Blogs

GLP-1 agonists have taken center stage in the treatment of type 2 diabetes and obesity¹, sparking intense demand and supply challenges. As stakeholders grapple with shortages and the emergence of compounded alternatives, it’s crucial to understand the current landscape and its implications for pharmacy benefits management. 

Current Availability of GLP-1 Agonists 

As of August 2024, the availability of GLP-1 agonists varies²: 

• In Stock: Ozempic, Mounjaro, Zepbound, and most strengths of Wegovy and Trulicity 
• Limited Availability: Saxenda, certain strengths of Trulicity, Victoza, and the 0.25 mg/0.5 mL dose of Wegovy 

Even with the above shortages, our data suggests that the situation may not be as severe as portrayed in the media. Many products are accessible, albeit with some limitations. 

Compounded GLP-1 Agonists: A Closer Look 

As shortages have been reported, some have turned to compounded versions of GLP-1 agonists. However, there are several important considerations^3,4: 

• Safety and Efficacy Concerns: The FDA has received reports of adverse events related to compounded semaglutide. Unlike FDA-approved medications, compounded drugs are not evaluated for safety, effectiveness, or quality. 
• Regulatory Issues: Some pharmacies are using unapproved salt forms of semaglutide, which do not comply with FDA standards for compounded drugs. 
• Administration Challenges: Compounded GLP-1 agonists are typically dispensed in multi-dose vials, requiring more skill and training for proper administration compared to the pen devices used for commercial products. 
• Limited Demand: Despite the national marketing blitz, our data shows no appreciable demand for compounded GLP-1 agonists among our membership. 

Recommendations  

Given these factors, we do not recommend expanding coverage to include compounded GLP-1 agonists.  

Looking Ahead 

As the demand for GLP-1 agonists continues to grow, it’s crucial to stay informed about their availability, safety considerations, and regulatory guidelines. Our Clinical Account Executives can help you navigate challenges relating to GLP-1 antagonist shortages and compounds.

By the Serve You Rx Clinical Department

References

1. The Lancet. (2023). Drug shortages: Addressing a global problem. The Lancet, 402(10396), 1617-1618. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)01185-6/abstract
2. U.S. Food and Drug Administration. (n.d.). Drug shortages. U.S. Department of Health and Human Services. https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages
3. U.S. Food and Drug Administration. (n.d.). Medications containing semaglutide marketed for type 2 diabetes or weight loss. U.S. Department of Health and Human Services. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss#:~:text=Can%20semaglutide%20be%20compounded?,on%20FDA’s%20Drug%20Shortages%20list
4. U.S. Food and Drug Administration. (n.d.). Drug compounding and drug shortages. U.S. Department of Health and Human Services. https://www.fda.gov/drugs/human-drug-compounding/drug-compounding-and-drug-shortages

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About Serve You Rx®   
Serve You Rx is a full-service pharmacy benefit manager (PBM) with unquestionable flexibility and an unwavering commitment to doing what's best for its clients. With a fervent focus on those it serves, including insurance brokers, consultants, third-party administrators, and their clients, Serve You Rx delivers exceptional service and tailored, cost-effective benefit solutions. Independent and privately held for nearly 40 years, Serve You Rx can implement new groups in 30 days or less and say "yes" to a wide variety of viable solutions. Known for its adaptability, quality, and client-centricity, Serve You Rx aims to be a benchmark for better client service.