Vytorin coverage will not change for people enrolled in health plans provided by UnitedHealth Group. The nation’s largest health insurer said it will continue paying for Vytorin, even though a recently released study showed it worked no better than cheaper statin drugs. Many health insurers have been reviewing their policies on Vytorin coverage because of that study – known as ENHANCE – and after a panel of prominent cardiologists recommended that Vytorin only be prescribed as a last resort for lowering cholesterol.
Vytorin, which was developed and marketed jointly by Merck and Schering-Plough, was approved for use by the Food and Drug Administration in 2004. Since it came on the market, Vytorin sales have reached $5 billion per year. But ENHANCE, which was released on January 14, showed that Vytorin was ineffective in preventing clogged arteries, and might actually increase plaque in some users. In spite of the findings, Merck and Schering-Plough delayed releasing ENHANCE for more than a year – something critics of the company have likened to fraud.
Over the weekend, the full ENHANCE study was vetted during the annual meeting of the American College of Cardiology. A panel of four doctors concluded that Vytorin should be used only as a last resort, considering that the expensive drug did not provide any added benefits. “Our strongest recommendation is that people need to go back to statins,” said panel member Dr. Harlan Krumhotz.
The Vytorin controversy has caused many insurers to reconsider covering the expensive drug. One factor that could influence health plans is whether medical societies change their guidelines for cholesterol-drug use. On Tuesday, the head of the American College of Cardiology told Dow Jones that it will publish new guidelines in the next few months giving physicians advice on which patients should be given Vytorin in light of the ENHANCE findings.
One insurer, Cigna Corp,. has already suspended part of a program that notified members using certain other cholesterol drugs that Vytorin was an effective and less costly alternative. The program, known as “step therapy,” is an effort to help health plans control drug costs. Cigna said its suspension of Vytorin’s role in the step therapy program would last until a committee of experts could review the latest study to decide if permanent coverage changes were needed. In the meantime, Cigna will continue to pay for Vytorin prescriptions, and the insurer stressed that no one should discontinue any therapy without first talking to a doctor.
But UnitedHealth Group has decided to keep paying Vytorin for now. UnitedHealth Group charges the lowest co-payments for generics, including a version of Zocor, in insurance plans sold to patients enrolled in Medicare prescription plans. The second, more expensive pricing tier includes Vytorin and Lipitor from Pfizer.
A spokesperson for the insurer told the New York Times that the current Vytorin policy will continue. “There were no safety issues raised in January or now,” Brian Solow, medical director of clinical services at Prescription Solutions, UnitedHealth’s pharmacy group, said Wednesday. “The last thing we want to do is see patients stopping their medication when they need it.” UnitedHealth has not required patients to try an alternate cholesterol-lowering drug before Vytorin in the past and has no plans to do so at this time, Solow said.
The news that the nation’s largest insurer is backing Vytorin is a rare bit o good news for the makers of Vytorin. According to The New York Times, Schering-Plough has lost $21 billion in market value since a preliminary report on the ENHANCE study was released in January. Since the recommendation of the American College of Cardiology recommendation, Schering-Plough has announced massive cutbacks that include laying off about 10 percent of its workforce and plant closures.