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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (465)	7/6/1998 4:05:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 1722

Reuters: Pfizer up despite refusal of HMOs to cover Viagra Monday July 6, 3:41 pm Eastern Time NEW YORK, July 6 (Reuters) - Shares of Pfizer Inc. (PFE - news) rose on Monday as the company vigorously defended the safety of its impotence drug Viagra amid refusals by two U.S. health insurers to pay for the medication because of safety concerns. Shares were up 1-1/16 to 108-9/16 in afternoon trade. The Wall Street Journal reported earlier Monday that Prudential HealthCare, a unit of Prudential Insurance Co of America, and Humana Inc. (HUM - news) decided late last week not to pay for Viagra due to concern about deaths and adverse reactions among men who took the drug. The U.S. Food and Drug Administration said in mid-June that it had received reports of about 30 men dying after taking the pill, which became the fastest-selling new drug in history after being approved by the agency three months earlier. But the FDA and Pfizer have said none of the deaths have been directly linked to the drug. Furthermore, they have said it is safe if used appropriately and that the deaths have raised no new concerns beyond warnings already noted on Viagra's label. Pfizer spokeswoman Mariann Caprino on Monday reaffirmed the company's strong faith in the drug's safety. She said over 2.5 million prescriptions had been written for Viagra -- typically for men over 45, many of whom have underlying health problems such as hypertension, diabetes and cardiovascular problems. ''The number of adverse events of people on Viagra is below what you would expect even in a general population of men who had never taken the drug,'' Caprino said. ''If you took two million men over age 45, you'd expect several hundred to die in any month. But the number of deaths among people taking Viagra is nowhere near that amount. We see nothing here that is cause for alarm,'' Caprino said. The FDA in June said several of the deaths were of men who were given nitroglycerin in violation of a prominent warning on the Viagra label that use of such ''organic nitrates'' by people taking Viagra could cause a dangerous fall in blood pressure. Other health maintenance organizations, including Kaiser Permanente and Aetna Inc. (AET - news) unit Aetna/U.S. Healthcare, have refused to cover Viagra, citing costs of the drug, which retails for about $10 a pill. But Caprino said Prudential and Humana were the first to deny coverage because of safety concerns. Hambrecht & Quist analyst Alex Zisson said he believed cost was clearly the dominant motivating factor spurring insurers to deny coverage for the blue, diamond-shaped pills. He said many seem to consider the drug more a ''lifestyle'' medication than a disease treatment. ''Lifestyle drugs are a problem for managed care companies because they are having a hard enough time paying expenses for serious diseases. Money they pay for quality-of-life drugs comes right out of their earnings,'' Zisson said. Federal health officials, however, have begun notifying states that their Medicaid programs must pay for Viagra although state officials may later end reimbursement for the drug if they determine it is being abused or inappropriately prescribed.

To: Anthony Wong who wrote (465)	7/6/1998 4:14:00 PM
From: Anthony Wong	Respond to of 1722

Pfizer Says Insurers Cause 'Unnecessary Fear' About Viagra July 06, 1998 3:24 PM NEW YORK -(Dow Jones)- Pfizer Inc., the maker of Viagra, is accusing insurers of instilling "unnecessary fear" in consumers by refusing to pay for the impotency treatment on safety grounds. Pfizer (PFE) began the offensive Monday in an unusual confrontation with insurers who hold the power to approve or disapprove its many drugs. It was responding to Prudential HealthCare and Humana Inc. managers who said their companies wouldn't reimburse patients for Viagra because they weren't sure it was safe. Prudential HealthCare, a unit of Prudential Insurance Co. of America, with more than five million members in managed-care plans, and Humana (HUM), a managed-care company with 6.2 million members, said last week they took the action because they weren't assured of the drug's long-term safety. Wall Street analysts questioned whether insurers looking for an excuse to avert the financial pain of paying for the pricey $10-a-pill impotency treatment. "Any challenges to the safety of Viagra are factually and medically incorrect," Pfizer spokeswoman Mariann Caprino said. "It's irresponsible to raise the concerns of the general public over the safety of this drug ... and it's causing unnecessary fear." At least 30 Viagra users have died since the drug came on the market in March. Pfizer and the Food and Drug Administration point out that users of the blockbuster drug are often elderly and have other health problems. Both maintain that there's no evidence any of the patients would have died if they took the drug as directed. Kaiser Permanente and other insurers have refused to cover Viagra because of the high cost. But Prudential and Humana officials say safety was their primary concern. "We had some concerns about the long-term safety effects of the drug," Humana spokeswoman Valerie Kennedy said. Prudential spokesman Kevin Heine went further, saying the insurer is concerned about the deaths and the risk to men who have recently had a heart attack. "We think it would be irresponsible to cover the drug without answers as to why those adverse situations occurred," Heine said. "If those concerns are addressed we will cover the drug." Neither company has contacted Pfizer to seek further safety information, Caprino said. "We would certainly welcome an opportunity to meet with them and put these concerns to rest," she said. Insurers are using safety concerns to mask their real reason for denying the drug - its budget-busting price, industry analyst Hemant K. Shah said. "There's no question about it," said Shah, an independent drug industry analyst in Warren, N.J. "It's very difficult to give other reasons (besides safety) because the consumer backlash could be quite significant." With the price of new drugs rising, insurers are drawing a line at covering what they deem to be "lifestyle" drugs, Shah said. For instance, if an employer pays an insurer $4,000 a year to cover a patient and the patient is taking two pricey drugs - such as Viagra and a cholesterol reducer such as Merck & Co.'s (MRK) Zocor - the insurer could spend half that amount on drugs alone. "You're going to see that more and more, with drugs being pushed off the reimbursement list, because managed care companies can't survive like that," Shah said. "The cost has skyrocketed." Heine at Prudential denied that cost was a consideration. He said the insurer performs a safety review first and hadn't even looked at cost. Prudential has denied coverage of other FDA-approved drugs because of safety concerns and found its caution was appropriate, he said. Among them were two diet drugs, the high blood pressure drug Posicor and the painkiller Duract, all of which were recalled by their manufacturers in the past year after the FDA expressed concerns over reported side-effects. Drug makers have raised demand for drugs through aggressive advertisements on television and in news magazines after the FDA made such pitches easier last year. Insurers had held drug costs below inflation levels until this year. But now prices have began to outpace inflation and some health care observers expect drug costs to jump 10% or more in 1999. Drug industry analysts say the controversy probably won't affect Pfizer's bottom line much even if more insurers decline to cover Viagra because patients won't let the drug's price tag deter them. The drug has 97% of the market for impotency-treatment drugs, with about 2 million users so far and nearly 146,000 new prescriptions in the week ended June 26 alone, according to industry researcher IMS Health of Plymouth Meeting, Pa. Harry, a 52-year-old Atlanta man, says he's bought 35 pills since March and hasn't even asked his insurer to pay for it. He spoke on condition he not be identified further because of the sensitive nature of impotency treatments. "You'd mortgage the farm for it," he said. "It's expensive, but it's well worth it." Copyright (c) 1998 Dow Jones & Company, Inc. All Rights Reserved.