Patients sue CVS Caremark over Zepbound formulary removal
The suit targets a mid-year coverage change that affected the most common CVS Caremark formulary template, which covers roughly 25 million to 30 million people.
Two patients filed a proposed class-action lawsuit against CVS Caremark on Sept. 3, 2025, alleging the pharmacy benefit manager stopped covering Zepbound (tirzepatide) because of a rebate agreement with Novo Nordisk, not because of clinical evidence [1][2][3]. The complaint, filed in the U.S. District Court for the Southern District of New York, brings claims under ERISA, the federal law governing employer-sponsored health plans, and demands a jury trial [1].
Plaintiffs Dennis Larkin and Danielle Gosline sue Caremark RX, L.L.C., which does business as CVS Caremark [1]. They allege the company breached its fiduciary duties and engaged in a prohibited transaction by pulling Zepbound from its formularies and giving preferred status to Wegovy (semaglutide), which is made by Novo Nordisk [1][2]. CVS Caremark removed Zepbound from its standard control, advanced control and value formularies effective July 1, 2025 [2].
The complaint describes the two patients' experiences. Larkin, of Mahopac, N.Y., received a Zepbound prescription in December 2023 for weight management and was diagnosed with severe obstructive sleep apnea in April 2024 [1]. His plan began using CVS Caremark on Jan. 1, 2025, and the company approved coverage that January, he says [1]. He refilled the prescription until June 19, 2025, when he was told his plan no longer covered Zepbound [1]. His first-level appeal was denied July 14, his second-level appeal was denied July 23, and a final external review denial reached him July 25, according to the complaint [1]. The denial letters said that "current plan approved criteria and current medical literature do not support the use of Zepbound over the available formulary alternatives," and named Wegovy as the primary covered drug, with a tirzepatide product, Mounjaro, as secondary [1]. Larkin started Wegovy on Aug. 9 and took a second dose on Aug. 16, and reported the return of gastroesophageal reflux disease, stomach pain, hunger and weight gain, the complaint states [1].
Gosline received a Zepbound prescription on Jan. 3, 2024, and CVS Caremark approved a new prior authorization on April 1, 2025, said to be valid through April 1, 2026, according to the complaint [1]. Her coverage request was denied July 1, 2025; she appealed July 7 and was denied July 8, the complaint says [1].
The scale is large. In 2024, CVS Caremark administered about 27% of all pharmacy benefit claims for the more than 154 million people covered under employer-sponsored health plans, the complaint states [1]. The July change applied to the most common formulary template, which represents between 25 million and 30 million individuals overall [3]. An analysis of electronic health records by Truveta for CNN found that about 1 in 10 people using Zepbound switched to a different GLP-1 in July, about 16 times more than typical, and that more than 8 in 10 of those switched to Wegovy [3]. New prescriptions for Zepbound fell for the first time in nearly a year, according to that analysis [3].
The two drugs are not the same molecule. Zepbound is tirzepatide, which Eli Lilly says targets both GIP and GLP-1 receptors; Wegovy is semaglutide, which targets GLP-1 [3]. On Dec. 20, 2024, Zepbound became the first and only FDA-approved drug to treat moderate-to-severe obstructive sleep apnea in adults with obesity, and Wegovy is not approved for that use, according to the complaint [1][3]. Novo Nordisk's Jason Brett said in a statement that "the notion that all GLP-1s are the same and 'interchangeable' is not correct" [3].
CVS Caremark says the lawsuit is "without merit." "We'll defend ourselves vigorously against those claims," David Whitrap, vice president of external affairs for CVS Health, said in an email [3]. A Caremark spokesperson said the formulary strategy "maintains clinically appropriate coverage while using competition to drive lower costs," and said a medical exceptions process exists for what the company described as the "rare cases" in which on-formulary options prove ineffective or cause harmful side effects [2][3].
Why it matters for patients
Millions of people whose pharmacy benefits run through CVS Caremark's most common formulary template were affected by the switch, and the timing mattered: some patients had prior authorizations that were honored in January and then denied in July [1][3]. Appeals can be exhausted within weeks, as Larkin's were, and the complaint says patients who stopped Zepbound "likely lost some of the gains in managing their health conditions that were realized while taking Zepbound" [1]. The lawsuit seeks to restore Zepbound coverage for people on CVS Caremark plans and "appropriate equitable relief" [3].
Switching is not a straight swap for everyone. Dr. Jody Dushay, an endocrinologist at Beth Israel Deaconess Medical Center, said there is no simple one-to-one dose conversion between Zepbound and Wegovy and that adjusting can take trial and error, with patients sometimes gaining weight or plateauing for a month [3]. She also said most switches have been acceptable but require extra work from doctors and pharmacists [3]. CNN reported that some appeals to stay on Zepbound have been approved and that some people switched with only mild side effects [3].
What happens next
The case was filed Sept. 3, 2025, and CVS Caremark has said it will defend itself [3]. The complaint seeks class-action status, but no hearing dates, rulings or timeline for the litigation have been reported. Whether the court certifies a class, and whether coverage is restored, has not been disclosed.
Sources
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