Patients Face Zepbound Drug Switch Post-Shortage

Patients Face Upset as Insurer Mandates Switch from Preferred Obesity Drug

Tens of thousands of individuals across the United States confront an unwelcome change to their healthcare plans. Their insurance mandates a shift away from a popular obesity medication towards an alternative generally associated with less substantial weight loss outcomes. This situation underscores the complex interplay between patient needs, pharmaceutical pricing, and the powerful intermediaries shaping access to medicines. The decision highlights how corporate negotiations can directly disrupt established treatment pathways, leaving many feeling powerless and concerned about their health progress. It brings into sharp focus the role of pharmacy benefit managers and the opaque nature of drug pricing agreements that ultimately dictate which treatments patients can receive.

The Contentious Formulary Change

CVS Caremark, a prominent pharmacy benefit manager (PBM) operating under the umbrella of CVS Health, initiated the controversial adjustment. The organisation decided to remove Zepbound, manufactured by Eli Lilly, from its standard list of covered medications, known as a formulary. Instead, patients needing obesity treatment under affected plans must predominantly use Wegovy, produced by Novo Nordisk. This move proceeded despite clinical evidence suggesting Zepbound often yields superior weight reduction results for many individuals. Research findings supporting Zepbound's potential advantage, initially publicised in late 2024, gained further validation. A significant clinical trial comparison, financed by Eli Lilly, saw its results published in The New England Journal of Medicine, confirming the earlier observations. Importantly, prior independent research efforts, not funded by the drugmaker, had also pointed towards similar conclusions regarding Zepbound's efficacy relative to Wegovy.

Patient Voices: Disruption and Distress

The impact of Caremark's formulary alteration resonates strongly with those directly affected. Ellen Davis, aged 63 and residing in Huntington, Massachusetts, exemplifies the patient perspective. After successfully using Zepbound for a year, achieving an 85-pound weight loss and notable health improvements, she faces an unwanted medication change. Ms Davis, a retiree after a long career with Verizon – a company utilising Caremark for prescription coverage – expressed feeling as though her stability was abruptly undermined. She articulated her frustration in a letter to Verizon, criticising the policy. Ms Davis argued the change forces individuals onto less effective medication against their personal preference and without clear medical rationale. Her experience mirrors that of many others navigating this unexpected treatment hurdle.

Online Mobilisation and Physician Concerns

News regarding the impending coverage removal for Zepbound disseminated rapidly through online channels following Caremark's official announcement. Healthcare professionals also voiced apprehension. Joseph Zucchi, working as a physician assistant at a weight-management clinic located in New Hampshire, took action. He established an online petition via change.org, calling upon Caremark to rethink its decision. It merits noting that Mr Zucchi had previously disclosed receiving compensation from Lilly for speaking engagements. By mid-May 2025, his petition had attracted significant attention, gathering over 2,700 signatures from concerned individuals. Caremark indicated its plan to cease Zepbound coverage would take effect in July 2025, intensifying the urgency for patients and prescribers seeking alternatives or exceptions.

Clinical Considerations and Treatment Flexibility

Medical professionals generally regard both Wegovy and Zepbound as valuable tools in combating obesity. However, many clinicians express a preference for Zepbound when initiating treatment for most patients, citing its efficacy profile. The formulary change imposed by Caremark substantially curtails doctors' capacity to personalise obesity medication regimens based on individual patient needs and responses. The ability to select the most suitable drug, considering factors like degree of weight loss required, tolerance to side effects, and pre-existing conditions, becomes restricted. Doctors emphasise that patient responses can vary significantly; some individuals might achieve better results or experience fewer adverse effects with Wegovy. Consequently, having both medications readily available allows for optimal patient management and adjustments if one proves less suitable than the other.

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Caremark's Rationale: Cost Containment Focus

CVS Caremark defends its decision as a strategic measure aimed at curbing escalating prescription drug expenditures for its clients, primarily employers. David Whitrap, a spokesperson for Caremark, stated the organisation leveraged its negotiating power. He explained Caremark positioned clinically comparable products against each other to secure the most advantageous net cost. Mr Whitrap claimed the deal involving Wegovy would result in a 10 to 15 per cent reduction in obesity drug spending for employer clients compared to the previous year's arrangements. He characterised the action as fulfilling the core PBM function: achieving lower drug prices through competitive negotiation. This rationale prioritises financial savings within the healthcare system, framing the exclusion as a necessary outcome of market dynamics.

Addressing the Efficacy Question

When questioned about the research indicating Zepbound's superior average weight loss, Caremark's representative, Mr Whitrap, acknowledged both medications demonstrate high levels of effectiveness. He further suggested that findings from controlled clinical trials do not always perfectly mirror patient outcomes observed in everyday clinical practice. This perspective implies that while trial data might favour one drug, real-world results could show less differentiation, thereby justifying the selection based primarily on cost. However, this stance overlooks the statistical significance reported in head-to-head studies and the preferences expressed by numerous clinicians based on their professional experience treating diverse patient populations. The debate highlights the inherent tension between population-level cost management and individualised patient care needs.

Manufacturer Perspectives and Market Positioning

Executives at Novo Nordisk, the maker of Wegovy, have publicly stated they did not lobby for Zepbound's exclusion from Caremark's formulary. They sought to distance their company from the PBM's decision, asserting that treatment choices should ideally rest with patients and their healthcare providers. Lars Fruergaard Jorgensen, Novo Nordisk's chief executive, reiterated this position to financial analysts, emphasising the principle of choice. Meanwhile, Eli Lilly faces the direct consequence of having its product restricted. This situation unfolds within a lucrative and rapidly expanding market for new-generation obesity drugs, currently dominated by these two pharmaceutical giants. Novo Nordisk had initially enjoyed a lead, but Eli Lilly's Zepbound had been steadily gaining market share prior to Caremark's intervention.

The Opaque World of Rebates and Fees

The financial mechanics underlying Caremark's decision involve complex negotiations centred on rebates. PBMs bargain with drug manufacturers for these payments in exchange for favourable placement on their formularies. These rebates theoretically reduce the overall drug cost passed on to employers and insurers. Additionally, manufacturers often pay substantial administrative fees directly to PBMs. For blockbuster drugs like Wegovy and Zepbound, these fees can represent considerable revenue streams for the PBMs, potentially reaching hundreds of millions of dollars annually. The precise figures associated with these rebates and fees remain confidential business information. Neither Novo Nordisk nor Eli Lilly disclosed the specifics of their financial offers during the negotiations with Caremark that led to Zepbound's exclusion.

PBM Market Power and Formulary Exclusions Trend

CVS Caremark, alongside Cigna's Express Scripts and UnitedHealth's Optum Rx, collectively governs approximately 80 per cent of the prescription drug market in the US. This concentration grants them immense leverage in negotiations. While Express Scripts and Optum Rx had not, as of mid-2025, implemented similar widespread blocks against either major obesity drug, the practice of formulary exclusion has become increasingly prevalent since around 2012. Research, partly supported by pharmaceutical industry funding, tracked a dramatic increase in medications excluded from at least one major PBM formulary. The number rose from just 50 in 2014 to 548 by 2022. This count specifically considered instances where patients were compelled to switch to a completely different medication, not merely a generic substitute or biosimilar.

Navigating Formulary Instability

Patients often find themselves caught off guard by abrupt changes to their medication coverage. Formulary lists undergo periodic updates, and drugs can be added or removed with little direct explanation provided to the end-user. Restrictions fluctuate frequently, sometimes leading to paradoxical situations where one PBM covers a specific drug while its competitor excludes it, and vice versa for another medication in the same therapeutic class. While experts suggest many formulary exclusions might not result in direct harm – and could occasionally lead to a beneficial switch – certain changes trigger significant backlash. The unpredictability and lack of transparency surrounding these decisions contribute to patient anxiety and complicate long-term treatment planning for chronic conditions.

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Precedents and Wider Impact

Caremark's move involving obesity drugs echoes previous controversial formulary adjustments. In 2022, the PBM mandated a switch for many patients from the widely used anticoagulant Eliquis to a rival medication, Xarelto. This decision provoked sharp criticism from medical societies, particularly after anecdotal reports surfaced concerning blood clots in patients whose treatment regimens were disrupted during the transition period. Notably, Caremark reversed its decision approximately six months later, reinstating coverage for Eliquis. Individuals managing chronic conditions like autoimmune diseases (such as arthritis) or respiratory illnesses (like asthma) frequently encounter forced medication changes. They might need to switch inhaler types or biologic therapies based on evolving formulary rules, causing disruption and requiring adaptation periods.

The Ripple Effect on Employers and Patients

The announcement of the Zepbound exclusion prompted an immediate response from affected employees. Representatives for employer groups reported receiving numerous calls and emails from workers covered by Caremark plans, seeking clarification on whether their specific plan would enforce the change. Although employers technically approve the PBM-managed formularies, they typically do not participate actively in constructing the lists or negotiating the underlying deals. They rely on PBMs to manage costs and access. The current situation places employers in a difficult position, balancing cost-containment objectives with employee well-being and satisfaction regarding their health benefits. Patients, meanwhile, express frustration at choices being made without their input or direct medical necessity.

Understanding the Scope and Exceptions

It is important to note that Caremark's change primarily affects individuals with certain types of private health insurance whose employers have adopted the PBM's most widely used formulary template. The restriction does not apply universally to all Caremark members. Furthermore, the exclusion specifically targets the use of these drugs for weight management. Patients prescribed tirzepatide (Zepbound's active ingredient) or semaglutide (Wegovy's active ingredient) for the treatment of type 2 diabetes under different brand names (Mounjaro and Ozempic, respectively) are generally not impacted by this particular formulary decision. Caremark has stated it will maintain a process for considering medical exceptions on a case-by-case basis, potentially granting continued Zepbound coverage for individuals who demonstrably require it.

The Limited Medical Exception Pathway

While Caremark offers a pathway for medical exceptions, securing approval may prove challenging for many patients. Mr Whitrap suggested exceptions might be considered for individuals who, for instance, had previously tried Wegovy and failed to achieve adequate weight loss or experienced intolerable side effects. However, numerous patients deliberately chose Zepbound in consultation with their doctors, often as their initial therapy, based on its perceived efficacy or specific patient factors. These individuals may not meet the criteria for an exception under Caremark's anticipated guidelines. Carl Houde, a 49-year-old resident of Saugus, Massachusetts, voiced this sentiment, stating he selected Zepbound collaboratively with his physician and found its potential removal distressing.

Patient Choices and Financial Considerations

Faced with losing insurance coverage, some patients indicated they were exploring the possibility of paying for Zepbound out-of-pocket to maintain their treatment continuity. This option, however, presents a significant financial barrier. Without insurance subsidies, these medications typically cost consumers around $500 per month or more, although manufacturer savings programmes can sometimes reduce this burden. Victoria Bello, 28, from Syracuse, New York, highlighted the substantial health benefits she gained from Zepbound and expressed anxiety about losing access. Her concern about potentially stalling her health progress underscores the real-world consequences of formulary restrictions, forcing difficult choices between health needs and financial capacity, particularly given the high list prices exceeding $1,000 per month before any discounts or insurance.

Understanding the Medications: Science and Side Effects

Both Wegovy and Zepbound belong to a class of drugs known as GLP-1 receptor agonists, initially developed for diabetes management. They function by mimicking gut hormones that regulate appetite and blood sugar. Wegovy mimics one such hormone, GLP-1. Zepbound represents a newer development, acting as a dual agonist, mimicking both GLP-1 and another hormone called GIP. Scientific thinking suggests this dual action contributes to Zepbound's potentially greater impact on weight reduction. The Eli Lilly-funded comparative trial involving 750 participants over 16 months illustrated this difference: high-dose Zepbound users lost an average of 50 pounds, compared to 33 pounds for Wegovy users. Both injectable medications share common side effects, including nausea, vomiting, diarrhoea, and constipation, with similar rates reported in the trial.

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Beyond Weight Loss: Cardiovascular Benefits

While weight reduction is the primary focus for obesity treatment, these medications offer additional health advantages. Both semaglutide (Wegovy) and tirzepatide (Zepbound) have demonstrated positive effects on cardiovascular health markers in clinical studies. Reducing weight often correlates with improvements in blood pressure, cholesterol levels, and overall heart health. Notably, Novo Nordisk successfully obtained regulatory approval to specifically market Wegovy for its cardiovascular benefits in certain patient populations, a claim Eli Lilly is also pursuing for Zepbound. Dr Jason Brett, a Novo Nordisk executive, emphasised that the number of pounds lost constitutes only one dimension of effective obesity management, highlighting the importance of these broader cardiovascular outcomes demonstrated by Wegovy in large-scale trials.

Regulatory Scrutiny and Calls for Reform

The practices of pharmacy benefit managers, including formulary exclusions and rebate negotiations, have attracted increasing attention from regulators and legislators in the United States. Concerns about market concentration, lack of transparency, and potential conflicts of interest have fuelled calls for reform. The Federal Trade Commission (FTC) has undertaken investigations into PBM business practices. Various legislative proposals at both federal and state levels aim to increase oversight, mandate greater transparency regarding rebates and fees, and potentially limit certain PBM tactics like spread pricing (where PBMs charge insurers more than they reimburse pharmacies). These efforts reflect a growing recognition that the current system, while intended to control costs, may inadvertently harm patient access and choice.

The Future Landscape: Competition and Costs

The intense competition between Eli Lilly and Novo Nordisk in the obesity drug market is likely to continue, potentially influenced by further clinical data, pricing strategies, and the introduction of new rival medications from other pharmaceutical companies. Several other firms are actively developing treatments targeting obesity through similar or novel mechanisms. The long-term trajectory of drug pricing and access will depend on these market dynamics, alongside the outcomes of regulatory scrutiny directed at PBMs. Patients like Elisabeth Degallier, 56, from Rochester, Minnesota, remain apprehensive. Having found Zepbound life-changing, she felt Caremark's decision prioritised financial metrics over scientific evidence. Her experience fuels broader anxieties about the stability of access to essential, effective – and often expensive – medications.