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New AIDS Drug May Be Too Costly for Many

March 14, 2003

WASHINGTON (AP) _ A new drug offers great hope to AIDS patients, but its price may put it out of reach for many, especially those who rely on state-funded, cash-strapped programs.

The Food and Drug Administration on Thursday approved Fuzeon, the first in a new class of medications to fight AIDS.

State AIDS directors had been awaiting the approval with excitement about its potential mixed with anxiety about its cost. Drug makers haven’t announced a U.S. price yet but said it would be close to the $20,400 per year they are charging in Europe.

The last resort for many patients, state AIDS Drug Assistance Programs already spend nearly $10,000 on the average patient. Fuzeon must be combined with some existing drugs, so its total cost per year could approach $30,000.

``Nothing would make me happier than to provide this for our clients,″ said Dwayne Haught, manager of the Texas ADAP. ``But that price tag _ I’m just shocked. I don’t see how we could do it.″

The Texas program is already considering cutbacks, including new limits on who qualifies.

In California and New York, states with large numbers of HIV-positive patients, ADAP officials are uncertain whether they will be able to cover the drug. Any new spending for Fuzeon in California will mean cuts in other spending on other AIDS drugs or new restrictions to the program, said Michael Montgomery, chief of the state’s Office of AIDS.

Nationally, ADAP programs serve more than 130,000 people each month. Murray Penner of the National Alliance of State and Territorial AIDS Directors said he didn’t know of a single state ADAP that plans to add Fuzeon to the list of drugs it will pay for.

His group plans to meet next week with Roche, the pharmaceutical company that makes Fuzeon, and other drug makers in an attempt to negotiate lower prices for AIDS treatments.

In the mid-1990s, when the previous class of AIDS drugs was first approved, they were quite expensive, and it took some time for all ADAPs to cover them.

``When those drugs first came on the market, all of a sudden ADAPs were in a crisis,″ said Jennifer Kates, director of HIV policy for the Kaiser Family Foundation. An emergency appropriation from Congress was needed to bail them out, she said.

Only about three in 10 patients who are being treated for HIV have private insurance. Nearly half of U.S. AIDS patients rely on Medicaid, the health insurance program for the poor. Some have Medicare, and about 20 percent have no health insurance at all.

Medicaid programs aren’t required to cover prescription drugs, but if they do, they have to cover all FDA-approved medicines. Under current law, states may not exclude a single drug because of its price.

President Bush has proposed an overhaul of Medicaid that would give states the authority to do just that. Participating states could cover some drugs but not others in order to control costs.

``They will have the potential to pick and choose,″ said Christine Lubinski, executive director of the HIV Medicine Association. She predicts most states would drop at least some AIDS drug coverage. ``We represent one of the more costly populations.″

Even without a change in law, Lubinski worries that states, which are facing extreme financial crises, will delay making Fuzeon available through Medicaid.

``If I was primarily responsible for worrying about the bottom line, I might drag my feet putting a drug as costly as this one on the Medicaid formulary.″

It has AIDS activists and others worried that the medical advance will leave behind those who can’t afford it.

``The excessive price of Fuzeon is going to bankrupt all of the public programs that provide drugs, severely tax private health insurance and result in thousands of people not being able to access life-extending treatment,″ John Riley of ACT-UP New York said Friday.

His group is pressuring Roche to lower the price. ``We believe this is extreme price gouging,″ Riley said.

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