As GLP-1 utilization expands and cost of coverage continues to rise for plans, employers and benefits consultants are examining additional coverage options. Among these approaches, carve-in and carve-out models represent two different pathways that employers are leveraging to control GLP-1 spend.
Carve-in models: GLP-1 carve-in programs are integrated with the PBM, and GLP-1 drugs are still processed through the pharmacy benefit. Utilization management rules will still be applied by the PBMs, thus retaining clinical oversight within the PBM. While the GLP-1s are still being processed by the PBM, there can be rebate impacts if these programs add certain restrictions. GLP-1 carve-in models most often consist of lifestyle management programs that can improve member engagement and adherence through structural support, while still maintaining clinical oversight through the PBM.
Carve-out models: GLP-1 carve-outs remove these medications from PBM processing, meaning no rebates, no formulary controls, and limited visibility into utilization. Some employers view this as a pathway to predictable pricing or lower cash-pay costs, while others are evaluating the risks tied to minimal oversight and the absence of standard utilization management.
Because GLP-1 medications are carved out of the pharmacy benefit, claims bypass the formulary and do not generate PBM rebates. This shift may also intersect with PBM contracting frameworks, given the removal of GLP-1 claims from typical rebate guarantees and utilization controls.
Two types of GLP-1 carve-out models have emerged: lifestyle management programs and manufacturer affiliated programs. Although both approaches move GLP-1 claims out of the PBM benefit, each carries distinct operational, clinical, and financial implications. Understanding how these models work can help employers navigate emerging solutions with greater clarity.
Lifestyle Management GLP-1 Carve-Out Programs
How It Works
Lifestyle GLP-1 carve-out programs, such as Omada and FlyteHealth, are structured clinical and lifestyle support models designed to influence member behavior and strengthen adherence. These GLP-1 carve-out programs provide an intensive management experience that goes beyond medication access alone.
Members enroll directly with the vendor rather than accessing GLP-1 medication through PBM coverage. Upon enrollment, members participate in a supervised program that may include baseline assessments, coaching, nutrition guidance, and regular monitoring. Vendors often rely on their own clinical teams, including physicians, nurse practitioners, dietitians, and health coaches.
The GLP-1 medication may be dispensed through the vendor’s own channels, through cash-pay structures, or through negotiated arrangements with pharmacies or manufacturers. Employers typically pay a per-member fee for program access, and in some cases, the vendor manages appropriate use criteria, adherence expectations, and continuation rules.
Benefits
Lifestyle GLP-1 carve-outs offer several potential advantages. They can improve member engagement and adherence through structural support, while also shifting clinical oversight and administrative responsibilities from employer to vendor.
Members also receive ongoing lifestyle support that may help maintain engagement and reduce discontinuation. This combination of external clinical oversight, behavior change strategies, and whole member support can support more consistent use and potentially improve outcomes.
Employers may experience reduced administrative burden, as clinical and operational responsibilities shift to the vendor. Pricing transparency may also improve, although actual savings vary and ROI remains mostly unproven.
Manufacturer GLP-1 Carve-Out Programs
How It Works
Manufacturer affiliated GLP-1 carve-out programs provide direct cash-pay access to medications through two types of arrangements: direct-to-consumer options and direct-to-employer partners. Because these claims do not run through the pharmacy benefit, prior authorization, step therapy, and PBM edits do not apply. Employers may permit HRA reimbursement, but spend does not count toward deductibles or accumulators. Unlike lifestyle programs, manufacturer models do not include clinical oversight, lifestyle coaching, or utilization management.
- Direct‑to‑consumer programs, such as NovoCare and Lilly Direct, offer lower cash‑pay pricing outside the benefit, leaving employers with no visibility into utilization and no rebate generation.
- Direct‑to‑employer programs, such as Waltz Health and 9amHealth, allow employers to “cover” GLP‑1 therapy outside the PBM while aiming to reduce per‑claim costs, but they may do so without clinical oversight or behavioral support.
Benefits
These programs offer lower per‑claim costs compared with PBM pricing, eliminate access barriers for members, and simplify administration for employers. For members, cash-pay access offers a faster, more straightforward, and predictable pathway. For employers, removing GLP-1s from the PBM contract may provide an alternative financial structure, though at the expense of oversight, visibility, and rebates.
Key Considerations for GLP-1 Carve-Out Programs
As employers and benefits consultants evaluate GLP-1 options, several considerations should be taken into account:
- GLP-1 lifestyle carve-out programs may impact PBM rebates, but these options provide lifestyle or clinical support, which may affect long‑term adherence.
- Manufacturer carve‑out programs come with meaningful trade-offs, including the absence of utilization management, which can increase the risk of inappropriate use.
- Direct‑to‑consumer arrangements can shift the full cost burden to members unless employers choose to allow HRA reimbursement.
Understanding the ways these models differ, and how each option may align with clinical priorities, member expectations, and overall financial goals, remains important as GLP-1 utilization continues to grow.