Insurers Taking Another Look at Vytorin CoverageApr 2, 2008 | Parker Waichman LLP
Insurers are said to be reconsidering coverage for Vytorin, after a study showed the cholesterol-lowering drug provided no added benefits over cheaper statins. Already, one large insurer has changed its approach to Vytorin coverage, and it is thought others will follow.
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. Vytorin is a combination of cholesterol-lowering Zetia and the statin Zocor. Statins like Zocor reduce the amount of cholesterol produced by the liver, while Zetia lessens the amount of cholesterol in food that is absorbed in the intestines. High cholesterol levels put a person at risk of developing clogged arteries – a major risk factor for heart attacks and strokes. Doctors and Vytorin users were led to believe that the drug would effectively reduce both sources of cholesterol, thereby lessening the amount of plaque build up in the arteries, as well as the risk of having heart attacks and strokes.
But the 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.
Now some insurers are considering following the panel's recommendation. Already, Cigna Corp. has 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. Under Cigna's step-therapy program, members can take "non-preferred" cholesterol drugs, but they have higher copays than "preferred" brands and generic drugs. 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.
Other insurers are also undertaking Vytorin reviews. An independent committee of experts that advises Medco Health Solutions Inc. on drug coverage policies "will be looking at the new data and be making recommendations on any changes" deemed necessary, Medco spokeswoman Ann Smith told Dow Jones Newswires. Another PBM, Express Scripts Inc., is reviewing the study, which the company says is standard practice whenever new drug data comes out. UnitedHealth Group Inc. one of the nation's largest health insurers, isn't making any immediate coverage changes for Vytorin, partly because medical guidelines haven't changed. But a committee will be reviewing the new data later this month.
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.