Medicare's new prescription benefit will cover sexual performance drugs, like Viagra, in addition to medications for such ailments as high blood pressure and heart disease, program officials confirmed Monday.
The move into what some consider "lifestyle" -- rather than life-saving -- pharmaceuticals is being criticized by conservatives, who see it as an unnecessary frill for a program that already is projected to cost at least $400 billion over its first decade.
"Ordinary Americans are going to be surprised," said Robert E. Moffit, a healthcare analyst at the Heritage Foundation, a conservative research and educational institution in Washington. "But this should not be a shock.... Once you create a universal entitlement, the tendency is for the entitlement to expand."
Clinical experts said that from a medical perspective, the decision made sense and followed the practices of private insurance plans and other government healthcare programs.
"These are drugs that treat a condition that compromises the quality of life but doesn't threaten life," said Dr. Ira Sharlip, a professor of urology at UC San Francisco. "But there are many drugs that are approved for quality-of-life indications. It wouldn't be right to single out [impotence drugs] as frivolous when there are so many others in the same category" -- such as prescription drugs for indigestion or mild pain, he said.
U.S. sales of drugs to treat impotence have leveled off at about $1 billion a year, despite heavy advertising on televised sports events and other promotional campaigns.
Winton Gibbons, a pharmaceutical industry analyst at William Blair & Co. in Chicago, said prescriptions for impotence drugs had grown 15% in the last 18 months, despite the introduction in 2003 of Bayer's Levitra and Eli Lilly & Co.'s Cialis to compete with Viagra.
"This is a market that's kind of hit a wall," Gibbons said. "We've had two new products, racier ads and seen just 15% growth."
According to Daniel Watts, a spokesman for Viagra manufacturer Pfizer Inc., men 60 to 69 account for about 22% of prescriptions for the drug, while those 70 and older account for about 17%. More than 15 million American men have tried Viagra since it was introduced in 1998, Watts said Monday.
Medicare's outpatient prescription benefit will take effect Jan. 1, and beneficiaries can begin signing up for the voluntary benefit this fall.
They will pay monthly premiums to participate in one of a number of private drug plans certified by Medicare; the government is expected to pay three-quarters of the premium cost as well as a percentage of annual drug costs.
Coverage by Medicare of "impotence agents" was recommended in guidelines issued last year by United States Pharmacopeia, a nonprofit, nongovernmental standards-setting organization. But Medicare made decisions on what to cover.
"The bottom line is that plans are allowed to provide them and will have to provide them," said a Medicare official who asked not to be identified. "But they can limit them only to medically necessary situations, and they can put quantity limits on them."
The Department of Veterans Affairs, for example, limits its patients to four doses of impotence drugs per month. Patients who ask for the drugs are supposed to undergo a thorough medical exam to try to determine the cause of their erectile dysfunction.
The VA originally had decided not to cover Viagra when it was introduced because of cost, but reversed its decision in 2001, a spokeswoman said. About 151,000 VA patients now are prescribed Viagra at a cost to the agency of $4.86 per tablet. Pharmacy prices average about $9 per pill.
What it will cost Medicare to cover these drugs is not known, agency and industry officials said. Medicare is counting on competition among the private drug plans to keep prices in check for all drugs.
"I don't think Medicare coverage is going to add much to the market size or much to Medicare costs," Gibbons said, because men between the ages of 40 and 60 make up the prime market for the drugs -- a group too young to qualify for the federal health insurance program for the elderly and disabled.
He estimated the new Medicare coverage would add $50 million to $100 million in total sales, a potential boost of 4% to 8%.
Alonso-Zaldivar reported from Washington and Gellene from Los Angeles.