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Crestor Left Off Insurer Listing

Drug called vital to AstraZeneca

Mar 10, 2004 | The News Journal A consultant to the nation's largest private health insurer and more than one-third of Fortune 500 companies did not include Crestor on a list of drugs it recommends for reimbursement by insurers and corporations.

The decision by Medco Health Solutions Inc. is a blow to the new cholesterol drug AstraZeneca PLC calls vital to its future.

Medco's recommendation could mean that companies and insurers won't pay for Crestor, or that patients who take it will pay more out of pocket.

Medco made its decision in recent weeks after a "clinical and financial review" of Crestor, spokeswoman Jennifer Leone said. The company would not detail the reasons for its recommendation.

AstraZeneca has said it has confidence in Crestor, especially when compared to rival drugs.

"We will continue to seek opportunities to partner with Medco in the future," AstraZeneca spokeswoman Rachel Bloom- Baglin said in an e-mail message.

The Medco recommendation already has had an impact.

General Motors Corp., a Medco client with 1.2 million beneficiaries making it the nation's largest self-insured corporate health plan, will not reimburse for Crestor.

"We're going to follow the recommendation of Medco," said GM spokeswoman Doris Powers.

Another Medco client, United Health Care, the nation's largest private health insurer, said it had included Crestor on its list of drugs approved for reimbursement, but at the highest of three out-of-pocket payment categories. United has about 21 million members.

Crestor was approved by the federal Food and Drug Administration last August for treatment of high cholesterol.

The agency approved Crestor pills in doses between 5 milligrams and 40 milligrams after AstraZeneca withdrew an earlier application that also included 80 milligram doses. The withdrawal followed clinical trials linking Crestor use at that dosage to kidney diseases.

Last week, Public Citizen, the Washington-based public advocacy group founded by presidential candidate Ralph Nader, petitioned the federal agency to ban Crestor, claiming there were 11 reports of life-threatening kidney ailments in Crestor patients in the United States, United Kingdom, and Canada, where AstraZeneca began selling the drug last year. In one case, a 39-year-old U.S. woman died of kidney disease.

All but one of the 11 reported cases cited by Public Citizen occurred in patients taking 40 milligrams or less of Crestor a day. The woman who died was taking 20 milligrams a day, along with several other medications.

In a statement released Saturday, AstraZeneca called Public Citizen's claims "misleading, irresponsible and needlessly alarming to patients.

"Crestor is the most extensively studied statin ever approved by FDA." AstraZeneca said. "More than one million patients have taken the medication, with more than two million prescriptions dispensed."

David Moskowitz, a vice president of Friedman, Billings Ramsey & Co. Inc., an Arlington, Va.-based investment bank, said reservations about the drug are having an impact.

"The fact that there are now several major insurance companies refusing to put Crestor on preferred status on their formularies suggests fears not just in the physician community, but in the insurance community," Moskowitz said.

Last October, WellPoint Health Networks Inc. said it would not reimburse its 15 million patients for Crestor. Among other issues, WellPoint cited concerns about kidney problems in clinical trials of Crestor. WellPoint would replace United Health Care as the nation's largest private health insurer if a pending merger is approved.

Lisa Mee-Stephenson, spokeswoman for WellPoint, said doctors can get WellPoint to reimburse for Crestor in most cases if they specify in writing a medical necessity for the drug. The patient would then need to make the highest co-payment, in most cases.

Mee-Stephenson said the insurer will review Crestor's status later this month. WellPoint said it has eight cholesterol-lowering drugs on its recommended list and Medco has three.

AstraZeneca executives have described Crestor's acceptance as solid.

For example, Advance PCS, another health care consultant that influences prescriptions for about 75 million Americans, recommended Crestor last fall with a relatively low out-of-pocket payment. A spokesman said the Irving, Texas-based consultant did so after its own review of the drug's safety and the federal drug agency's approval.

AstraZeneca told Wall Street last fall that it hoped Crestor would capture up to one-fifth of the $20 billion annual worldwide market for statins, whose sales are led by Pfizer Inc.'s Lipitor, the world's best-selling prescription drug.

"Crestor is central to our ambitions, it is off to a very good start and we are confident we will make it a major megabrand," AstraZeneca's chief executive, Sir Tom McKillop, told analysts in January.

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