Erectile Drugs for the Elderly?

Where do you stand? Is sex a “lifestyle” decision or a vital aspect of medical health? Should prescriptions be limited to 4 a month? Is erectile dysfunction a “normal” sign of aging?

Excepted from:

Companies Fight to Ensure Coverage for Erectile Drugs

by: ROBERT PEAR
from: The New York Times, February 22, 2005

WASHINGTON, Feb. 21 - Drug companies are strenuously resisting bipartisan efforts in Congress to prohibit Medicare from paying for Viagra and other drugs for erectile dysfunction.

The issue of whether Medicare's new prescription drug benefit should cover such treatments is raising broader questions of ethics, economics, politics and health policy.

"It's a huge issue," said Jonathan P. Weiner, a professor of health policy at Johns Hopkins University. "We cannot pay for everything, but, unlike many advanced industrial countries, the United States has no explicit process to analyze the cost and value of medical goods and services."

The debate centers on whether a drug used to enhance sexual performance should even be eligible for Medicare coverage. Proponents of providing the coverage say that erectile dysfunction often has a physical cause and that treatment can significantly improve the quality of a man's life. Opponents say that Medicare, already growing at an unsustainable rate, cannot afford to pay for "lifestyle drugs."

Administration officials said recently that, under their reading of the new Medicare drug benefit, they had to pay for drugs like Viagra, Levitra and Cialis when they were prescribed.

This came as a surprise to many members of Congress. Their concern was heightened by new estimates indicating that the overall drug benefit would cost much more than they were told when they voted on the legislation in November 2003.

"The thought of Medicare wasting vital resources on performance-enhancing drugs is unconscionable," said Representative Steve King, Republican of Iowa. "The focus should be on providing coverage for needy seniors."

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But Kindra L. Strupp, a spokeswoman for Eli Lilly & Company, which sells Cialis, says that 17 percent of that drug was dispensed to men over the age of 65.

"Erectile dysfunction is not a trivial thing for men who suffer from it," Ms. Strupp said. "We've heard from thousands of men that it can interfere with their intimacy, erode their relationships with their partners, damage their self-esteem and lead to depression."

In addition to Cialis by Lilly, Pfizer makes Viagra and GlaxoSmithKline markets Levitra. All three are pushing to ensure Medicare coverage and cite a number of reasons.

In an interview and an e-mail message, Andrew B. McCormick, a spokesman for Pfizer, said his company was focusing on three areas:

"Erectile dysfunction is a medical condition," recognized by doctors and by other health insurance programs.

When men seek treatment for erectile dysfunction, doctors often find evidence of underlying conditions like diabetes and high blood pressure that would otherwise have gone undetected.

Medicare drug plans can prevent abuse of Viagra and similar drugs by using "restrictive formularies," requiring prior authorization, charging higher co-payments or limiting the number of pills that can be dispensed. Private plans sometimes cover the drugs, with those kinds of restrictions.

In older men, erectile dysfunction is often caused by disease or surgical procedures that damage the nerves or obstruct the flow of blood.

"For a 70-year-old man with hardening of the arteries caused by smoking, for a man with diabetes or multiple sclerosis, or a man who has had pelvic surgery for cancer, there are clear medical indications for these drugs," said Dr. William F. Gee, chairman of the health policy council of the American Urological Association.

But the drugs are promoted to a much larger audience. In November, the Food and Drug Administration sharply criticized Pfizer for television advertisements suggesting that Viagra could restore the sexual appetite of a man shown gazing into the window of a lingerie shop. "The TV ads omit the indication for the drug, namely, treatment of erectile dysfunction," the F.D.A. said in a letter to Pfizer.

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For people without insurance, the retail pharmacy price for Viagra is typically $9 to $11 a pill. In 2001, the drug was added to the list of those covered by the Department of Veterans Affairs, which is entitled to certain discounts by law and negotiates additional discounts. The V.A. says it pays less than $5 a pill.

But the agency recommends that its doctors prescribe no more than four tablets a month. Veterans received 1.9 million prescriptions for Viagra through the V.A. health care system last year.

Drugstore.com, the online pharmacy, charges $90.99 for 10 pills. Prices for Levitra and Cialis are similar.

The chief Medicare actuary, Richard S. Foster, estimates that Medicare drug plans "can initially achieve an average cost reduction of 15 percent" in 2006, by negotiating discounts and taking steps to manage use of various drugs. Savings will grow to 25 percent in five years, Mr. Foster predicts.

There are sharp divisions on the question of whether erectile dysfunction drugs are medically necessary.

"These are essentially lifestyle drugs," said Daniel J. Callahan, co-founder of the Hastings Center, a bioethics research institute in Garrison, N.Y. "This is not a good way to spend a limited amount of money, at a time when other medical needs are greater. In many men, impotence is simply a function of age, though it may also be a result of disease."

"A possible compromise solution," Mr. Callahan said, "would be to set specific medical criteria allowing Medicare coverage for these drugs when erectile dysfunction can be traced to some identifiable medical condition other than age."

Robert P. George, a member of the President's Council on Bioethics, endorsed that approach.

"If impotence occurs in the normal course of a human life, as a consequence of aging, these drugs should not be covered," said Mr. George, a professor of jurisprudence at Princeton. "But if there is a real health problem, I am inclined to say the drugs should be covered."

Health officials in Germany, Britain, Sweden and other countries have struggled with the same issue and made similar distinctions.

Arthur L. Caplan, director of the Center for Bioethics at the University of Pennsylvania, said the issue had forced policy makers to ask, "What emphasis will we give to quality of life as a goal for pharmacological intervention?"

"Erectile dysfunction drugs don't save anybody's life, but make life more meaningful," Mr. Caplan said. "A fundamental principle of medical ethics is respect for the patient's right to self-determination. If you ask Medicare beneficiaries what they want, you will find that sexual function is high on the list. Many men would say that sexual dysfunction is just as important as loss of the ability to hear or to walk a mile."


Copyright 2005 The New York Times Company

original web page: http://www.nytimes.com/2005/02/22/politics/22medicare.html?th