GLP-1 medications such as Ozempic, Wegovy, Mounjaro, and Zepbound have rapidly transformed the management of diabetes and obesity, becoming some of the most requested treatments within employer-sponsored health plans.
However, the high cost and frequent shortages of these FDA-approved drugs have led employers and patients to explore compounded GLP-1 medications as an alternative. As a pharmacist, I aim to provide clarity on the safety, efficacy, and innovative strategies employers can use when considering compounded GLP-1 therapies.
GLP-1 Medications: Why All the Buzz?
GLP-1 receptor agonists have gained widespread acclaim due to their demonstrated clinical efficacy in managing Type 2 diabetes and supporting significant weight loss, while reducing cardiovascular risk factors.
The FDA continues to approve these medications for more uses, making these treatments even more attractive to patients and employers. Additionally, exciting pipeline developments such as oral semaglutide and dual and triple agonists like retatrutide suggest continued growth in this therapeutic area.
Given the pace of GLP-1 innovation, employer policies should remain adaptable to emerging clinical evidence and regulatory developments, such as label expansions, updated prescribing guidelines, new safety alerts, or FDA decisions regarding compounded and novel therapies.
Understanding Compounded GLP-1 Medications
Compounded GLP-1 medications are prepared by compounding pharmacies, usually at a lower cost than branded alternatives. Unlike FDA-approved medications, compounded versions bypass the rigorous clinical trials and strict oversight typically required.
Employers and patients might consider compounded versions during severe shortages or for significant cost savings, but these medications call for careful consideration. Employers should seek compounding pharmacies accredited by reputable bodies such as PCAB (Pharmacy Compounding Accreditation Board).
Employers and patients might consider compounded versions during severe shortages or for significant cost savings, but these medications call for careful consideration. Employers should seek compounding pharmacies accredited by reputable bodies such as PCAB (Pharmacy Compounding Accreditation Board).
Pharmacist Concerns About Compounded GLP-1s
From a pharmacist’s perspective, compounded GLP-1 medications present several risks:
- Safety risks: Potency can vary significantly between batches, increasing the risk of suboptimal dosing or overdose. Past documented issues have included contamination and improper storage, leading to serious adverse reactions.
- Efficacy risks: Lack of formal clinical testing means effectiveness can vary. Degradation due to improper storage, lack of bioequivalence studies, and absence of structured safety monitoring programs such as REMS or post-market surveillance may result in unpredictable clinical outcomes. Degradation due to improper storage and absence of bioequivalence studies may result in unpredictable clinical outcomes.
- Regulatory and legal risks: Compounded medications do not have FDA approval, potentially exposing employers to liability under ERISA and pharmacy benefit management contracts.
- Reputational risks: Adverse outcomes from compounded medications could lead to negative media coverage, damaging the employer’s reputation.
- Dosing variability alert: Compounded GLP-1s may differ in concentration or formulation compared to branded products, creating potential for confusion or error in administration.
FDA Shortage Update: Why This Still Matters
Although the FDA has removed certain GLP-1 medications like Ozempic or Wegovy from its official drug shortage list as of 2024, access challenges and demand surges persist in many real-world settings. Pharmacies may still experience delays or limited inventory depending on region, patient volume, or dosage strength. More importantly, employers continue to face financial pressure and member demand for alternatives. This makes it critical for plan sponsors to clearly define when compounded GLP-1s are clinically appropriate and legally supportable, even in a post-shortage environment.
A Pharmacist-Recommended “Place in Therapy” Framework
To responsibly manage compounded GLP-1s, employers should adopt clear guidelines.
Appropriate use:
- During significant shortages or when branded medications are unattainable
- When a patient has a documented allergy or intolerance to an inactive ingredient in the FDA-approved product
- When a clinically justified dose or formulation is not commercially available — for example, micro-dosing or alternative administration
- When a patient faces financial barriers and no affordable FDA-approved options are available, with documented clinical oversight and informed consent
Inappropriate use:
- Simply for convenience or general cost-cutting without exploring other available, safer options
- For widespread, elective use without individualized clinical justification
- When used as a first-line alternative in place of available FDA-approved medications
Decision-making checklist for employers:
- Confirm PCAB or equivalent pharmacy accreditation
- Require third-party testing for purity, potency, and sterility
- Clarify 503A vs. 503B status and associated legal protections
- Review batch documentation and recall history
- Obtain signed employee consent outlining known risks
Innovative Employer Strategies for GLP-1 Management
Here are some innovative, practical strategies for GLP-1 management that are grounded in pharmacy best practices.
Digital health integration
Digital health platforms can enhance weight loss and chronic condition management through virtual clinical oversight, behavioral coaching, and data-driven interventions. When evaluating these programs, assess not only user experience, but also licensed provider oversight, patient safety protocols, regulatory alignment, and the level of effort required for integration with existing benefit ecosystems.
Examples:
Virta Health delivers a nutrition-first, medically supervised weight loss and diabetes reversal program with integrated GLP-1 deprescribing protocols. Across its client base, Virta has:
- Discontinued GLP-1 use in over 50% of active users
- Kept GLP-1 utilization under 25% across all weight loss members
- Achieved about 5% average weight loss in 90 days, with durable outcomes post-medication
- Optional outcomes-based contracts available for employers seeking risk alignment
Omada Health supports chronic disease and weight management through connected devices, digital coaching, and virtual care teams. In a 2025 analysis of 1,124 GLP-1 users without diabetes:
- 94% persisted at 12 weeks, and 84% at 24 weeks compared to typical rates as low as 33%
- Users who remained on GLP-1s through 24 weeks achieved 12.1% weight loss, while early discontinuers lost 7.4% resulting in a 64% relative improvement
- Omada’s companion support model helped members reach clinical trial-level outcomes in real-world settings
Outcomes-based contracting
This model shifts financial risk from the employer to the vendor by tying payment to the achievement of predefined clinical outcomes. It’s best suited for pilot programs or GLP-1-specific carve-outs, where employers want cost containment without compromising access.
Request contract samples with clear definitions of success, such as weight loss thresholds, A1C reductions, and deprescription rates, as well as transparent claims-based performance validation.
Example:
Twin Health delivers personalized, data-driven care through its “digital twin” platform, aiming to reverse chronic metabolic disease without relying on GLP-1 medications. The program operates under a 100% outcomes-based contract with no per member, per month (PMPM) fees.
- Employers only pay when predefined outcomes are achieved
- Guaranteed improvements in A1C, weight loss, and deprescription of GLP-1s and other medications
- ROI is validated using pharmacy and medical claims data
- Reported outcomes include a 2.2-point average A1C reduction for members with starting A1C greater than8.0 and a 14-pound average weight loss for members with a BMI greater than 30, based on internal data from Twin Health’s commercial populations as of September 2024
- Demonstrated reductions in diabetes-related pharmacy spend while maintaining clinical appropriateness
Precision medication management
Employers can start by using claims and clinical data to identify risk levels and guide GLP-1 eligibility. This includes applying evidence-based criteria such as BMI thresholds, diagnosis history, and documentation of prior lifestyle interventions. Emerging tools like pharmacogenomics may offer future potential for personalization but should be adopted cautiously until validated for clinical use at scale.
Examples:
- A Truveris analysis of over 1.1 million GLP-1 claims from early 2023 to early 2025 found that GLP-1 spend increased fivefold, with a 16% average cost increase per claim, highlighting the need for utilization strategies such as step therapy, targeted prior authorization, and indication-based coverage.
- Pharmacogenomic research suggests that genetic differences may affect GLP-1 treatment response. In a genome-wide study of over 4,500 adults with type 2 diabetes, 4% of patients with favorable variants in the GLP1R and ARRB1 genes saw a 30% greater reduction in HbA1c after six months of therapy.
GLP-1 budget modeling
Work collaboratively with actuaries, pharmacy consultants, and PBMs to forecast utilization, model benefit tiering scenarios, and project the impact of step therapy or lifestyle-first pathways on total cost of care.
Example:
- WTW reported that GLP-1 medications now represent 16% of pharmacy spend, up from 1% in 2020, highlighting the importance of modeling three- to five- year budget exposure and management levers.
Practical Tools and Employer Resources
Employers seeking further insights or personalized guidance should consult with pharmacists and benefits experts. When exploring digital health programs or vendor partnerships, it is essential to critically evaluate clinical oversight, regulatory compliance, and outcomes reporting to ensure alignment with your organization’s standards and member safety.
Equip your HR and benefits team with actionable resources, such as these:
- Employee Education Article: Clearly communicate risks, benefits, and appropriate use of compounded GLP-1 medications
- Employer Pharmacy Checklist: Criteria for selecting reputable compounding pharmacies, ensuring rigorous quality control and safety measures
Key Takeaways
- Compounded GLP-1 medications pose clinical, legal, and reputational risks if not properly managed.
- Their place in therapy extends beyond shortages to include documented ingredient intolerances, non-standard dosing needs, and financial hardship with appropriate safeguards.
- Employers must vet compounding pharmacies thoroughly and require third-party testing and documented employee consent.
- Innovative strategies like digital health integration, outcomes-based contracting, and predictive analytics can optimize safe access while managing cost and utilization.
Balancing Innovation, Safety, and Affordability
Navigating compounded GLP-1 medications demands a careful, pharmacist-informed strategy. By clearly understanding the safety, efficacy, and regulatory landscape, employers can adopt innovative approaches that protect employee health, minimize risks, and manage costs effectively.
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