Patients sue CVS Caremark over dropping Zepbound from its formularies
The case tests whether a pharmacy benefit manager can move patients off a GLP-1 drug their prescribers call medically necessary in order to favor a cheaper competitor.
A class-action lawsuit accuses CVS Caremark of unlawfully dropping coverage for Zepbound, a tirzepatide drug, and steering members to Wegovy, a semaglutide drug, according to a Sept. 5, 2025 report on the filing [1].
Earlier in 2025, Caremark said it would remove Zepbound from its standard control, advanced control and value formularies effective July 1, and instead give preferred status to Novo Nordisk's Wegovy, arguing the two medications are interchangeable [1]. The case was filed in New York's Southern District Court [1].
The plaintiffs say the pharmacy benefit manager is shirking its fiduciary duty under the Employee Retirement Income Security Act, or ERISA, because their providers had deemed Zepbound medically necessary for them [1]. One patient in the suit was later diagnosed with sleep apnea, a condition Zepbound is approved to manage [1].
"Plaintiffs' claims for coverage for their Zepbound prescriptions were improperly denied, and the arbitrary and capricious denials issued by CVS Caremark ignored the language of the underlying plans, the reasons why Zepbound is medically necessary for each Plaintiff, and overruled the recommendations of Plaintiffs' skilled and knowledgeable medical providers," the lawsuit states [1].
A dispute over whether the drugs are interchangeable
The lawsuit challenges the idea that the two drugs are clinically equivalent, noting they are different molecules within the broader GLP-1 class: Zepbound is tirzepatide and Wegovy is semaglutide [1]. The plaintiffs say some patients who had severe symptoms on semaglutide had a milder experience with tirzepatide, and they note that drugs in this class carry separate approvals for additional conditions. Zepbound is the only product approved by the FDA for patients with obesity and sleep apnea, according to the suit [1].
The complaint also argues Zepbound has been shown to be more effective for weight loss, and says that on its formulary page explaining the switch, CVS acknowledges studies with that implication exist while stating that "real-world evidence suggests the two are comparable" [1].
"Because of their different methods of action, different clinical outcomes, and different side effects for individual patients, Zepbound and Wegovy are not clinically interchangeable," the plaintiffs said in the complaint [1].
CVS has said that giving preferred formulary status to Wegovy is critical to promoting competition that can drive down costs, and that GLP-1s are a major cost concern for employers and other plan sponsors [1]. Formulary placement is one of the general tools pharmacy benefit managers use to manage costs on behalf of clients [1].
A Caremark spokesperson told Fierce Healthcare that the lawsuit is "without merit" and that the company intends to defend itself, adding that Caremark does have an exemption process in place if needed [1].
"Our formulary strategy maintains clinically appropriate coverage while using competition to drive lower costs," the spokesperson said. "By drawing upon our decades of expertise in making prescription drugs more affordable and accessible, we are confident that our formulary move means lower costs and better outcomes for consumers and our customers" [1].
Why it matters for patients
Formulary decisions made by pharmacy benefit managers largely determine which GLP-1 drug a covered patient can get and what they pay for it. When a plan drops a drug that a prescriber considers medically necessary, patients can face denied claims, appeals or a switch to a different molecule. The lawsuit argues that patients who were doing well on Zepbound were moved off it for reasons tied to the plan's costs rather than their care [1].
It has not been reported whether the court has certified the case as a class action, or how many patients it would cover if it is certified. The outcome of the case is not yet known, and no ruling has been reported [1]. Whether CVS Caremark has changed its formulary decision since the July 1, 2025 effective date has not been reported [1].
What happens next
Caremark has said it will defend against the suit and points to an exemption process for coverage requests [1]. No schedule for further filings, hearings or a decision has been reported [1].
Sources
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