A category-action lawsuit has been filed in opposition to CVS Caremark over its choice to cease covering Zepbound, Eli Lilly’s blockbuster GLP-1 drug to deal with weight problems.
When the key pharmacy profit supervisor informed patients about the change this year, it recommended that there was “another covered medication that’s safe and effective for your condition and may cost less”: particularly Wegovy, from Novo Nordisk, with which CVS Caremark introduced a partnership simply earlier than the change took impact.
But many sufferers and their medical doctors say the therapies aren’t medically interchangeable.
John Cole, who lives within the Midwest, says he misplaced greater than 60 kilos over the course of about 5 months whereas utilizing Zepbound. Letters from his household drugs physician, heart specialist and rheumatologist all point out that he’s benefited from this therapy. But he’s gained some weight again after shedding entry to Zepbound by CVS Caremark, and his care crew has submitted dozens of letters to the corporate over the previous two months amid repeated attraction denials.
“It is my professional opinion that the patient’s health problems all seem to be improving on Zepbound and we would be hesitant to switch medications when things are going well,” one in all Cole’s medical doctors wrote to CVS Caremark.
Zepbound and Wegovy are each efficient at treating weight problems and accepted by the US Food and Drug Administration to take action, however there are variations.
Studies have found that individuals who used tirzepatide injections corresponding to Zepbound misplaced extra weight and had been extra prone to attain particular weight reduction targets than these utilizing semaglutide drugs corresponding to Wegovy. The two medication have a completely different set of broader indications, with Zepbound additionally accepted to deal with sleep apnea in folks with weight problems, for instance. Side results can range too, generally making one remedy extra tolerable than the one other.
The lawsuit, filed Wednesday within the Southern District of New York, alleges that the change from CVS Caremark – and subsequent denials of affected person and physician appeals – violates requirements for evaluating the medical necessity of therapy choices beneath the Employee Retirement Income Security Act, which is relevant to employer-sponsored well being plans.
“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 criticism reads. “And as studies have proven, Zepbound is more effective than Wegovy in achieving weight loss, and only Zepbound is has been proven effective and approved by the FDA for treating sleep apnea in patients with obesity.”
The lawsuit seeks to revive protection of Zepbound for folks on CVS Caremark plans and award different “appropriate equitable relief.”
CVS Caremark says the go well with is “without merit.”
“We’ll defend ourselves vigorously against those claims,” David Whitrap, vice chairman of exterior affairs for CVS Health, mentioned in an e mail.
CVS maintains that Wegovy and Zepbound are “two clinically similar products” and that “forcing the drug manufacturers to compete with one another on price” will encourage each Eli Lilly and Novo Nordisk to decrease costs for their merchandise within the US and broaden entry total.
“Our formulary strategy maintains clinically appropriate coverage while using competition to drive lower costs. 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,” Whitrap wrote within the e mail, additionally noting that a medical exceptions course of is offered for the “rare cases” during which “on-formulary options prove ineffective or cause harmful side effects.”
The protection change made by CVS Caremark in July applies to the most typical formulary template, which represents between 25 million and 30 million people total.
An unique analysis of electronic health records for NCS by Truveta, a health-care knowledge and analytics firm, means that it has had a important influence nationwide.
About 1 in 10 folks utilizing Zepbound switched to a completely different GLP-1 in July, the primary month after the change – about 16 occasions greater than typical, in keeping with the Truveta knowledge. The overwhelming majority of those that stopped utilizing Zepbound – greater than 8 in 10 – switched to Wegovy.
And total prescribing charges for Zepbound in July had been half of what that they had been for the previous yr and a half, the Truveta analysis found. New prescriptions for Zepbound fell for the primary time in practically a yr, whereas first-time prescriptions for Wegovy – which had been declining – noticed the most important month-to-month improve in additional than a yr.
Neither drug producer commented on the lawsuit particularly, however they emphasised the variations between their merchandise.
Eli Lilly says that Zepbound is a twin receptor agonist that “targets both GIP and GLP-1 receptors, unlike other incretins approved for obesity management, which target only GLP-1 receptors.” And Novo Nordisk says that Wegovy has the “broadest GLP-1 label,” together with indications for decreasing danger of main hostile cardiovascular occasions in some sufferers and for therapy of a sure liver situation in some adults.
“The notion that all GLP-1s are the same and ‘interchangeable’ is not correct,” Jason Brett, govt medical director for Novo Nordisk, mentioned in a assertion.
Some appeals to remain on Zepbound have been accepted and different folks have been capable of change to Wegovy with solely gentle negative effects, however the change has been disruptive for many sufferers and their medical doctors.
The course of is burdensome, mentioned Dr. Jody Dushay, an endocrinologist at Beth Israel Deaconess Medical Center and assistant professor of medication at Harvard Medical School.
“The majority of the switches have been OK; however, ‘OK’ means extra work for the pharmacist with whom I work and for me,” she mentioned.
Also, there’s not a easy one-to-one conversion for Zepbound and Wegovy doses, and it will probably take a lot of trial and error to make the change acceptable.
“When the dosing is not right, people may gain weight or plateau for a month and get frustrated,” Dushay mentioned. “I’m deliberately more conservative with dosing so that people don’t get slammed with side effects.”
Cole says he’s spent extra 100 hours over the previous two months working to regain protection for Zepbound – and the logistics and medical adjustments take him away from the issues he cares about.
“When I got [Zepbound], I tell everybody, it’s like a gift to be able to lose this weight and to feel so much better and spend time with the grandkids and be able to go on walks and move around the yard,” he mentioned. “Now, it’s something I shouldn’t have to be going through. They should be cared about my health and not take things away from me.”