Pharmaceutical intermediary ceases coverage for a GLP-1 drug used in treating obesity; legal action ensues.
CVS Caremark's Decision to Discontinue Coverage of Zepbound Sparks Controversy
A class-action lawsuit has been filed against CVS Caremark over its decision to stop covering Zepbound, Eli Lilly's blockbuster GLP-1 drug to treat obesity. The lawsuit alleges that the change from CVS Caremark and subsequent denials of patient and doctor appeals violate standards for evaluating the medical necessity of treatment options under the Employee Retirement Income Security Act.
The change has been disruptive for many patients, taking time and resources away from them and their care. Cole, a patient affected by the change, expressed his frustration, stating that the change takes away from the things he cares about, like spending time with his grandkids. He has spent over 100 hours working to regain coverage for Zepbound.
CVS Caremark maintains that Wegovy and Zepbound are "two clinically similar products." However, studies have found that people who used tirzepatide injections such as Zepbound lost more weight and were more likely to reach specific weight loss targets than those using semaglutide medications such as Wegovy. Zepbound is also approved to treat sleep apnea in people with obesity, while Wegovy does not have this approval.
Jason Brett, executive medical director for Novo Nordisk, the manufacturer of Wegovy, stated that all GLP-1s are not interchangeable. He emphasized that Wegovy has the "broadest GLP-1 label," including indications for reducing risk of major adverse cardiovascular events in some patients and for treatment of a certain liver condition in some adults.
Dr. Jody Dushay, an endocrinologist, noted that when the dosing is not right, people may gain weight or plateau, leading to frustration. The process of switching from Zepbound to Wegovy is burdensome, requiring extra work for pharmacists and doctors, and there's not a simple one-to-one conversion for doses.
The coverage change made by CVS Caremark in July affected the most common formulary template, representing between 25 million and 30 million individuals. In July, overall prescribing rates for Zepbound were half of what they had been for the past year and a half, while first-time prescriptions for Wegovy saw the largest monthly increase in more than a year.
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, with the vast majority switching to Wegovy. Neither drug manufacturer commented on the lawsuit specifically, but Eli Lilly emphasized that Zepbound targets both GIP and GLP-1 receptors, unlike other incretins approved for obesity management.
The lawsuit seeks to restore coverage of Zepbound for people on CVS Caremark plans and award other "appropriate equitable relief." CVS Caremark suggested that there was "another covered medication that's safe and effective for your condition and may cost less" when informing patients about the change, namely Wegovy from Novo Nordisk.
The complaint against CVS Caremark regarding the discontinuation of Zepbound treatment was signed by Eli Lilly. The change has raised concerns about the role of pharmacy benefit managers in healthcare decisions and their impact on patient care. The case is ongoing, and the outcome will likely have implications for how pharmacy benefit managers make decisions about which treatments to cover in the future.
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