Introduction
Obesity is no longer viewed solely as a lifestyle problem; it is increasingly recognized as a chronic disease with multiple comorbidities that demand long-term medical management. The rapid rise of GLP-1 receptor agonists, including semaglutide (Wegovy) and tirzepatide (Zepbound), has transformed treatment expectations by offering both clinically significant weight loss and measurable improvements in conditions closely linked to obesity. Yet, until recently, many of these drugs remained locked behind insurance exclusions, labeled simply as “weight-loss medications” and therefore excluded from coverage by Medicare and often restricted by private insurers.
This landscape began to shift in 2024, when the Food and Drug Administration (FDA) approved two new indications that redefined how these therapies are positioned in medical care. In March, Wegovy became the first drug authorized to reduce the risk of major adverse cardiovascular events such as heart attack and stroke in adults with obesity or overweight who also have established cardiovascular disease. Later in the year, Zepbound was granted approval for treating obstructive sleep apnea (OSA) in adults with obesity, following strong clinical trial evidence that the drug significantly reduced the severity of apnea events.
These regulatory decisions carry weight far beyond the clinical trials. An FDA indication does more than validate scientific findings; it provides the legal and practical basis for insurance coverage. Medicare, which is legally prohibited from covering drugs “for weight loss,” can nevertheless cover them if the drugs are prescribed for cardiovascular disease or sleep apnea. Commercial insurers and Medicaid programs, often guided by FDA labels, are also more likely to include drugs on their formularies when indications target serious, high-cost conditions.
The implications are immediate: patients may now access these drugs not only through weight-management programs but also via cardiology or sleep medicine. At the same time, questions of affordability, equity, and sustainability remain unresolved. This article explores how the 2024 FDA approvals for Wegovy and Zepbound are reshaping access to anti-obesity medications, what they mean for patient care pathways, and how insurers are responding to this shifting therapeutic landscape.
FDA’s Role in Expanding Indications
The Food and Drug Administration plays a unique role in shaping the reach of prescription drugs. While the agency does not directly decide what insurers cover, its authority to grant indications effectively determines whether a drug is seen as a “lifestyle aid” or a treatment for disease. For anti-obesity medications, this distinction has historically meant the difference between exclusion and reimbursement. Until recently, most drugs for weight management were viewed with caution. Early “diet pills” had poor safety records, leading to strict coverage exclusions across Medicare and many private health plans. The Medicare Modernization Act of 2003 explicitly barred coverage of drugs used for “weight loss,” codifying the idea that such treatments were not medically necessary. Insurers often mirrored this stance, citing both cost concerns and a lack of compelling evidence. As a result, millions of patients with obesity could not access pharmacological therapy unless they paid out of pocket.
The situation began to change as clinical trials demonstrated that newer GLP-1 drugs had effects beyond weight reduction. Wegovy, a formulation of semaglutide, reduced cardiovascular risk in high-risk populations. Zepbound, based on tirzepatide, improved symptoms of obstructive sleep apnea, a condition with substantial morbidity and healthcare costs. Once the FDA added these indications to official labeling in 2024, the regulatory category of the drugs shifted. They were no longer simply “weight-loss medications” but therapies for recognized diseases with clear endpoints such as reduced heart attacks or improved apnea indices.
For patients, the impact of this change is significant. Coverage decisions by Medicare, Medicaid, and commercial plans are closely tied to the FDA label. A drug approved for “obesity” alone may be excluded, but a drug approved for “cardiovascular disease” or “sleep apnea” enters a different reimbursement framework. The label becomes the passport to coverage.
The mechanism is straightforward but powerful. Insurers often require that prescriptions match an FDA-approved indication. When physicians code the diagnosis as cardiovascular disease or obstructive sleep apnea, and the drug’s label supports that use, coverage becomes legally defensible. Without such a label, insurers can (and often do) deny claims on the basis that the drug is cosmetic or non-essential.
However, this process does not eliminate all barriers. Plans still decide on formularies, may impose prior authorization, and often set high cost-sharing requirements. But the FDA’s indication provides the foundation on which these decisions rest. Without it, coverage is impossible. With it, coverage becomes at least negotiable.
Another important dimension is perception. Physicians are more willing to prescribe a drug once the FDA recognizes its effect on a serious condition. Patients may feel less stigma receiving a prescription for cardiovascular protection or sleep apnea rather than for “weight loss.” Employers and policymakers, too, tend to view coverage for these indications as more legitimate. Thus, FDA approvals change not just the legal but also the cultural landscape around obesity treatment.
The 2024 approvals of Wegovy and Zepbound illustrate this transformation. By anchoring the drugs in conditions with high healthcare costs and established insurance frameworks, the FDA has indirectly expanded patient access. It has also set a precedent: future approvals for kidney disease, heart failure, or other obesity-linked disorders could further broaden coverage. Each new indication adds another pathway into the healthcare system.
At the same time, these developments underscore the limitations of relying on label expansions. Access remains fragmented, with patients who do not meet the criteria for cardiovascular disease or sleep apnea left outside the system. The underlying statutory exclusion in Medicare still exists, meaning obesity alone is not sufficient for coverage. FDA actions can soften the barrier, but only Congress can dismantle it.
To put it shortly, the FDA’s role is catalytic. Its decisions do not guarantee universal access, but they shift the balance from exclusion to possibility. For anti-obesity drugs, the new indications in 2024 may be remembered as the point when the conversation moved decisively from lifestyle to disease management, forcing insurers and policymakers to reexamine long-standing exclusions.
Wegovy and Cardiovascular Risk Reduction (FDA 2024 approval)
When the FDA approved semaglutide (Wegovy) in March 2024 for reducing major adverse cardiovascular events in adults with obesity or overweight and established cardiovascular disease, it marked a turning point. This was the first time an anti-obesity drug was recognized not only for weight management but for preventing life-threatening outcomes such as heart attack and stroke. The implications extend well beyond cardiology; they reshape how the drug is prescribed, reimbursed, and perceived within the healthcare system.
Evidence behind the approval
The decision was driven by results from the SELECT trial, a global, randomized study involving more than 17,000 participants. Patients with overweight or obesity and established cardiovascular disease but without diabetes were assigned to semaglutide or placebo. Over several years, the semaglutide group demonstrated a 20% reduction in major cardiovascular events compared with placebo. The benefits were consistent across subgroups, regardless of age, sex, or baseline weight. For clinicians, this was crucial evidence. Previous studies had shown that GLP-1 receptor agonists could improve glycemic control and promote weight loss, but SELECT proved cardiovascular protection independent of diabetes management. The FDA approval in March 2024 formally translated that evidence into a label, enabling prescribers to recommend Wegovy not only for obesity but as a cardiovascular therapy.
How the indication changes patient routing and coverage
Before this approval, patients interested in Wegovy usually sought it through weight-management clinics or primary care providers focused on obesity. Coverage was inconsistent, particularly under Medicare, which is prohibited from paying for drugs “for weight loss.” Commercial insurers frequently denied claims unless patients met stringent body mass index criteria and failed multiple attempts at lifestyle intervention. The new cardiovascular indication alters the pathway. Cardiologists can now prescribe Wegovy directly to patients with established heart disease, coding the treatment under a cardiovascular diagnosis. This provides the legal basis for Medicare Part D coverage and gives commercial insurers a strong rationale to include the drug in formularies. Instead of being routed through weight-loss programs, patients can enter through cardiology clinics, reframing the drug as part of secondary prevention rather than cosmetic therapy.
This shift is already influencing payer behavior. Several national insurers announced in late 2024 that they would add Wegovy for cardiovascular risk reduction to their preferred drug lists, albeit with prior authorization. Requirements typically include documented cardiovascular disease, BMI above a set threshold, and sometimes a trial of statin or other cardioprotective medication. Such guardrails are designed to control spending while offering access to the highest-risk patients.
Medicare Advantage plans, which cover nearly half of all Medicare beneficiaries, have also begun updating formularies. Some plans cover Wegovy on higher cost-sharing tiers, others with step therapy. While not seamless, the key change is that coverage is now possible, where previously it was categorically excluded.
Patient impact and broader implications
For patients with obesity and cardiovascular disease, the new indication represents an opportunity to access a drug that may extend life and reduce disability. The psychological shift should not be underestimated. Being prescribed Wegovy “for the heart” rather than “for weight” can reduce stigma and encourage adherence. Patients may be more motivated to continue therapy when the goal is preventing heart attack rather than merely lowering a number on the scale.
Still, barriers remain. Wegovy’s list price is more than $1,300 per month. Even with Medicare’s new $2,000 annual out-of-pocket cap beginning in 2025, many patients will struggle to afford copayments. Cost remains the single biggest obstacle to widespread adoption. Discontinuation rates in commercial populations have been high, often due to financial burden as much as side effects.
The broader public health implications are complex. On one hand, widespread use of Wegovy in high-risk populations could prevent thousands of cardiovascular events annually, saving billions in hospitalizations and long-term care. On the other, if uptake expands faster than expected, Medicare and private insurers could face enormous near-term costs. Analysts at the Kaiser Family Foundation have warned that balancing these competing dynamics will be a central policy challenge. Physician practice patterns are also evolving. Cardiologists are increasingly collaborating with endocrinologists and obesity specialists to manage GLP-1 prescribing. This interdisciplinary approach reflects the reality that cardiovascular disease, obesity, and metabolic dysfunction are deeply intertwined. Yet it also raises training and capacity questions: not every cardiology practice is prepared to monitor patients on GLP-1 therapy, particularly regarding gastrointestinal side effects or dosing protocols.
Finally, the FDA’s approval for cardiovascular risk reduction sets an important precedent. It signals to drug developers and insurers alike that the pathway to broad coverage is through comorbidity indications. Future trials are already targeting kidney disease and heart failure. Each positive result could carve out another insurance pathway, gradually normalizing GLP-1s as standard-of-care for chronic disease prevention.
In general, the March 2024 approval of Wegovy for cardiovascular risk reduction transformed the access landscape. It provided a bridge between obesity medicine and mainstream cardiology, opened Medicare coverage for the first time, and reframed a weight-loss drug as a disease-modifying therapy. The challenge now is whether the healthcare system can balance cost with access, ensuring that patients who need protection against cardiovascular events can actually obtain and sustain therapy.
Zepbound and Obstructive Sleep Apnea (FDA 2024 approval)
In December 2024, the FDA granted tirzepatide (Zepbound) a new indication for treating obstructive sleep apnea (OSA) in adults with obesity. This was the second major label expansion for an anti-obesity drug that year, following Wegovy’s cardiovascular approval. Together, the two decisions signaled that the FDA was no longer viewing these medications solely through the lens of weight loss but as treatments for serious chronic conditions.
Evidence and clinical impact
The approval was based on results from the SURMOUNT-OSA trial, which enrolled adults with obesity and moderate-to-severe OSA. Participants treated with Zepbound showed a significant reduction in apnea-hypopnea index (AHI), a key measure of sleep apnea severity, compared to placebo. Improvements were observed regardless of whether patients were using continuous positive airway pressure (CPAP) devices, the long-standing standard of care. This is clinically meaningful because OSA is strongly linked to obesity and contributes to a cascade of complications, including hypertension, cardiovascular disease, and daytime fatigue that impairs quality of life. Weight reduction has long been known to alleviate OSA, but pharmacologic options were limited. With Zepbound, physicians now have an FDA-approved therapy that targets the underlying obesity while directly addressing apnea outcomes.
For patients, this changes the treatment conversation. Instead of being told to rely solely on CPAP, lifestyle changes, or in some cases surgery, adults with OSA related to obesity now have access to a medication shown to reduce disease severity. Specialists in sleep medicine may increasingly collaborate with endocrinologists or obesity physicians, expanding the care pathway for a condition that affects an estimated 30 million Americans.
Implications for coverage and access
The insurance implications of this approval are substantial. Unlike obesity, OSA is widely recognized as a serious medical disorder with clear diagnostic criteria and significant healthcare costs. Payers already reimburse for sleep studies, CPAP equipment, and surgical interventions. By approving Zepbound for OSA, the FDA gave insurers a strong rationale to cover the drug under an existing, well-accepted disease category.
Medicare coverage remains limited to FDA-approved indications, but because OSA is not excluded by statute in the way obesity is, Zepbound prescriptions coded under this diagnosis are eligible for reimbursement. This distinction obesity vs OSA determines whether patients can access therapy. Private insurers are expected to follow suit, particularly as reducing untreated OSA lowers risks of heart disease, stroke, and costly hospitalizations.
Still, utilization management will be tight. Many plans are likely to require documented sleep study results, minimum severity thresholds, and possibly evidence of CPAP intolerance before authorizing Zepbound. These safeguards are intended to direct treatment toward patients with the highest burden of disease while containing costs. From a policy perspective, the Zepbound approval underscores how FDA decisions can reroute patient entry points. Instead of obesity clinics, many patients will now access medication through sleep specialists. This broadens the population eligible for pharmacotherapy and normalizes anti-obesity drugs as part of mainstream care. It reframes the drug not as elective but as necessary for managing a serious, chronic disorder.
The challenges remain familiar: high prices, coverage variability, and questions about long-term adherence. Yet the symbolic weight of the FDA’s OSA approval is undeniable. It positions tirzepatide as more than a weight-loss medication, carving out a space within sleep medicine and reinforcing the idea that obesity drugs can deliver disease-specific benefits.
How New Indications Reshape Coverage and Patient Access
The FDA’s 2024 approvals for Wegovy and Zepbound did more than validate trial results; they restructured the map of patient access. By anchoring these drugs in cardiovascular disease and obstructive sleep apnea, the agency shifted them from a contested category into conditions with established insurance frameworks.
Coverage rules now follow a clearer logic. For Medicare, Wegovy can be reimbursed under its cardiovascular indication, and Zepbound can be prescribed for OSA, neither of which are subject to the statutory exclusion that blocks obesity-only drugs. For Medicaid, states have stronger grounds to add GLP-1s to formularies since both indications target chronic, high-cost conditions. Commercial insurers, too, are more inclined to cover therapies that prevent heart attacks, strokes, or untreated sleep apnea complications.
The effect on patient routing is already visible. Instead of entering through weight-management programs, patients are being referred by cardiologists or sleep specialists. This broadens access beyond obesity clinics and integrates GLP-1 therapy into mainstream medicine. A patient with prior myocardial infarction may now receive Wegovy from a cardiologist, while someone diagnosed with severe sleep apnea may be offered Zepbound by a pulmonologist. Each pathway reframes treatment from optional weight control to necessary disease management. Yet, these shifts also highlight inequities. Patients without cardiovascular disease or OSA remain excluded, despite having obesity that significantly impairs health. Insurers may still enforce prior authorization or step therapy, slowing uptake. High list prices continue to deter sustained use, especially among lower-income groups. The danger is a two-tiered system in which only those with the “right” comorbidity can obtain medication through insurance.
Still, the 2024 indications represent a decisive move toward normalizing pharmacologic treatment of obesity-linked conditions. They demonstrate how regulatory recognition can unlock coverage, reshape clinical pathways, and redefine these drugs as part of chronic disease care. The door is not yet fully open, but it is wider than ever before.
Risks, Challenges, and Future Directions
The FDA’s new indications for Wegovy and Zepbound create opportunities, but they also raise challenges. Chief among them is cost. At list prices above $1,000 per month, widespread use could strain Medicare, Medicaid, and private insurers. Even with out-of-pocket caps under Medicare Part D, affordability remains uncertain, especially for patients on fixed incomes.
Another issue is adherence. GLP-1 therapies are associated with gastrointestinal side effects, and discontinuation rates in real-world settings are high. If patients stop therapy early, the expected reductions in cardiovascular events or sleep apnea severity may not materialize, undermining both clinical outcomes and cost-effectiveness. Equity also looms large. Those without cardiovascular disease or OSA remain excluded from coverage, even if their obesity leads to other serious complications. This selective access risks widening disparities, particularly for low-income groups and racial minorities who bear a disproportionate burden of obesity.
Looking ahead, more label expansions are on the horizon. Trials are underway for kidney disease and heart failure, conditions that could open further coverage pathways. Policymakers must decide whether to continue relying on incremental FDA approvals or to pursue legislative reform that directly addresses obesity treatment.
Conclusion
The 2024 FDA approvals of Wegovy for cardiovascular risk reduction and Zepbound for obstructive sleep apnea have redefined the role of anti-obesity drugs in U.S. healthcare. By tying these therapies to serious chronic diseases, the agency provided a pathway for Medicare, Medicaid, and commercial insurers to begin covering them, breaking through long-standing exclusions. For patients, this means expanded access routes: not only through weight-management programs but also via cardiology and sleep medicine. Coverage is still constrained by price, prior authorization, and eligibility criteria, yet the shift is undeniable. GLP-1 drugs are no longer framed as cosmetic but as disease-modifying interventions.
The future will hinge on balancing cost, equity, and sustainability. Whether through further FDA label expansions or congressional reform, access to these therapies is likely to grow. The question is not if, but how broadly, and how fairly, coverage will extend.
References
- Food and Drug Administration. (2024, March 8). FDA approves first treatment to reduce risk of serious heart problems specifically for adults with obesity or overweight. U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-reduce-risk-serious-heart-problems-specifically-adults-obesity-or
- Food and Drug Administration. (2024, December 20). FDA approves first medication for obstructive sleep apnea in adults with obesity. U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/news-events/press-announcements
- Wilding, J. P. H., Batterham, R. L., Calanna, S., Davies, M., Van Gaal, L. F., Lingvay, I., … & Kushner, R. F. (2021). Once-weekly semaglutide in adults with overweight or obesity. The New England Journal of Medicine, 384(11), 989–1002. https://doi.org/10.1056/NEJMoa2032183
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