(Updated to include Cigna news in paragraphs three, 11 and 12.)

By Peter Loftus

Of DOW JONES NEWSWIRES

Some major U.S. drug-benefit plans are reviewing a negative study of cholesterol pills Vytorin and Zetia to see if any changes in their reimbursement policies are warranted.

Such reviews are critical because they could lead to restrictions on health- plan payments for the drugs, which are marketed by a joint venture of Merck & Co. (MRK) and Schering-Plough Corp. (SGP). Any restrictions could further hurt sales of Vytorin and Zetia, which are already under pressure due to cardiologists' calls that they be prescribed less.

So far, only Cigna Corp. (CI) has said it was adjusting its coverage policy. The Philadelphia health insurer said it was immediately suspending 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.

If Cigna - as well as the other drug-benefit plans and health insurers - conclude that no change is needed, then Vytorin and Zetia could maintain their largely favorable positions in drug plans. Health plans might not see a need for any changes because the new data don't raise any significant safety concerns about the drugs.

An independent committee of experts that advises Medco Health Solutions Inc. ( MHS) 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.

The committee meets about four times a year, and the next meeting is scheduled for later this month, Smith said. Medco and other pharmacy-benefit managers, or PBMs, administer drug-benefit plans for employers and managed-care companies.

Another PBM, Express Scripts Inc. (ESRX), is reviewing the study, which spokesman Steve Littlejohn said is standard practice whenever new drug data comes out. The review itself doesn't necessarily mean Express Scripts would change its coverage policy for Vytorin and Zetia, he said.

UnitedHealth Group Inc. (UNH), one of the nation's largest health insurers, isn't making any immediate coverage changes for Vytorin or Zetia, partly because medical guidelines haven't changed. But a committee will be reviewing the new data later this month, spokeswoman Lynne High said.

"As of now we aren't making any changes but we'll clearly review the evidence as it's made available to us," High said.

Another large insurer, WellPoint Inc. (WLP), already has Vytorin on the "third tier" of its list of preferred drugs than some other health plans. That means out-of-pocket costs for members are generally higher than for drugs in the first two tiers. Vytorin's position isn't expected to change with the release of the full study results, spokeswoman Kristin Binns said. Zetia is on the second tier, but new prescriptions must get prior authorization from the insurer.

As for Cigna, the insurer 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. A spokeswoman declined to say when the committee would make a decision; meanwhile, though, 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.

Under Cigna's step-therapy program, members can take "non-preferred" cholesterol drugs such as Pfizer Inc.'s (PFE) Lipitor and AstraZeneca PLC's ( AZN) Crestor, but they have higher copays than "preferred" brands and generic drugs.

On Sunday, researchers at a medical meeting in Chicago presented full results of the so-called "Enhance" study, which showed Vytorin - a combination of the drugs Zetia and simvastatin - was no better than simvastatin alone at slowing artery thickening, despite producing a greater drop in bad cholesterol levels. The results led some cardiologists to recommend that use of Vytorin and Zetia be limited due to lack of evidence they reduce the risk of heart attacks and related disease more than older cholesterol drugs such as simvastatin.

Merck and Schering-Plough have emphasized that the drugs are effective at lowering levels of bad cholesterol, and that medical guidelines call for lowering bad cholesterol in order to stave off heart problems. A larger, ongoing study is testing whether the cholesterol benefit of Vytorin translates into reduced risk of heart disease, but results won't be known for several years.

Merck and Schering-Plough have indicated that they plan to defend their drugs before insurers, to ensure they maintain their favorable reimbursement policies. The drugs had combined sales of $5.2 billion in 2007, but analysts expect a decline in 2008 on lower prescription volumes.

On Monday, Deepak Khanna, general manager of the Merck/Schering-Plough partnership, indicated he was optimistic that drug plans wouldn't make any drastic changes to their reimbursement policies. Managed-care companies understand that Vytorin can help get some patients to their cholesterol goals when simvastatin can't, he said.

The preliminary results of the Enhance study were released in January. Shortly thereafter, two-thirds of a managed-care executives who answered a survey said they were unlikely to make immediate changes to their coverage policies for Vytorin and Zetia.

The survey, conducted by research firm Cognet-X Inc., of Bensalem, Pa., showed that many health plans already had policies in place to ensure Vytorin and Zetia were used appropriately. These include "generics-first" policies that provide incentives for people to try cheaper generics such as simvastatin before trying Vytorin or Zetia.

Medical guidelines generally call for doctors to start patients on statins - which include simvastatin and Pfizer Inc.'s (PFE) Lipitor - and to escalate their doses when possible. They should add Zetia or switch to Vytorin only if cholesterol goals aren't met or if patients can't tolerate higher statin doses.

Cognet-X is now conducting another survey to see if the full presentation of the Enhance data will change the thinking of managed-care executives, said Sharon Bender, executive director of strategic studies at the firm.

One factor that could influence health plans is whether medical societies change their guidelines for cholesterol-drug use.

The head of the American College of Cardiology said Tuesday the heart- specialist group will put out new guidelines in the next few months giving physicians advice on which patients should be given Vytorin and Zetia, in light of the new data. In Chicago at the group's annual meeting, ACC chief executive Jack Lewin noted that it will be at least four years before results looking at whether Vytorin and Zetia cut the number of heart attacks and strokes will be available, and doctors need advice in the interim.

-Peter Loftus; Dow Jones Newswires; 215-656-8289; peter.loftus@dowjones.com

(Jennifer Corbett Dooren contributed to this article.)

  (END) Dow Jones Newswires
  04-01-08 1752ET
  Copyright (c) 2008 Dow Jones & Company, Inc.