Washington Blade - June 27, 2003
Lou Chibbaro Jr.

The panel, the Drug Advisory Committee for the D.C. HIV/AIDS Administration, postponed a decision on whether to add Fuzeon to the list of AIDS-fighting drugs made available through the AIDS Drug Assistance Program, or ADAP, two members of the committee said. ADAP pays for life-saving AIDS medications for low-income people who don't have private health insurance but whose income is too high to qualify for Medicaid.

HAA, which makes the final decision on whether to accept drugs into the program, traditionally has followed the recommendations of the advisory committee.

Advisory committee members Rick Elion, a D.C. physician who treats people with HIV, and Ron Mealy, who heads an AIDS patient advocacy group, said most members of the panel believe they need more information on the impact of the high cost of Fuzeon on the D.C. ADAP program before making a decision to recommend its approval.

The two said they are leaning toward the approval of Fuzeon once they are assured it won't lead to the bankruptcy of the District's ADAP program. But some AIDS activists said the city has enough money to support the new drug and the panel should have moved quickly to approve it.

"People are going to die while they drag their feet," said Wayne Turner, head of the local AIDS protest group Act Up D.C.

Turner said Fuzeon is needed now to save the lives of a growing number of people who are no longer helped by existing AIDS drugs.

Douglas Ward, a D.C. physician whose private practice specializes in treating people with HIV, said he and other area physicians began prescribing Fuzeon to patients with private health insurance in April, when the U.S. Food & Drug Administration approved its use as an AIDS drug.

Eileen Guertler, a spokesperson for the Virginia State Health Department, said Virginia added Fuzeon to its ADAP program shortly after the FDA approved the drug in April.

"We try to run this program with a low overhead cost," Guertler said. "This is another great opportunity for us to try to help our patients."

Lisa Soloman, director of the Maryland State AIDS Administration, said a state advisory board has been deliberating over whether to recommend the approval of Fuzeon for Maryland's ADAP program. She said the board was scheduled to vote on the issue on June 26. Soloman said the state has sufficient funds to cover the cost of providing Fuzeon for the next year.

"We will be fine for now," she said.

High cost a concern

Elion and Mealy pointed to the high price that F. Hoffmann-La Roche, the pharmaceutical company that manufactures the drug, is charging for Fuzeon. The firm initially said it would charge more than $20,000 for a year's supply of the drug for each patient. It has since announced it would provide a discount for the ADAP programs, bringing the price down to about $16,000 a year per patient. The reduced price is still nearly twice as high as the next most expensive AIDS drug.

The high price for Fuzeon prompted state and local health officials to demand a meeting with Hoffmann-La Roche's corporate executives and leaders of other drug companies to discuss ways to lower the cost of AIDS drugs. The heads of some ADAP programs said they would have to choose whether to withhold Fuzeon from their formularies of drugs or place caps on the number of patients admitted into their programs.

"We first looked at it and developed a pre-authorization approach," said Elion of the HAA advisory committee.

"But we decided we should find out what next year's [ADAP] budget would be. We did not want to approve it and then have to cut off people already in the program."

Mealy, who also serves as executive director of the Carl Vogel Center, an advocacy group for people with HIV, said he urged the committee to gather more information on the number of people who would likely benefit from Fuzeon in D.C.

"I'd like to find out how many people experienced treatment failure who would need Fuzeon," Mealy said.

"I'd like to see an analysis."

Because the committee usually meets only four times a year, it was not expected to resume its discussion on Fuzeon until August.

Joy Maatman, a government affairs representative with HoffmanûLa Roche, said that in response to her inquiry, HAA official Carolyn Rachel sent her an e-mail stating that HAA had chosen not to approve the use of Fuzeon for the ADAP program "at the present time."

Ivan Torres, HAA's acting administrator, said HAA is awaiting the final recommendation of its advisory committee before making a decision on whether to add Fuzeon to the list of drugs offered by D.C.'s ADAP program.

"We have not finalized our decision," he said.

ADAP is funded by the federal government and administered by all 50 states and the District of Columbia under the federal Ryan White CARE Act. The act calls for the states and D.C. to operate individual ADAP programs and to utilize advisory panels of doctors, other health care experts and citizens to help decide which drugs should be approved for the program.

Congress is currently deliberating over the ADAP budget for fiscal year 2004.

Turner and Patricia Hawkins, deputy executive director of D.C.'s Whitman-Walker Clinic, said they believe the city has sufficient funds to pay for Fuzeon without jeopardizing its ADAP program.

Gay D.C. Council member Jim Graham (D-Ward 1), the former executive director of the Whitman-Walker Clinic, called the advisory panel's action "a very questionable decision." Fuzeon is an "important, contributing drug" for the treatment of people with HIV, Graham said, which some patients may need immediately.

Graham said he would write a letter to HAA asking for an explanation for any decision to further delay the approval of Fuzeon.

Hawkins noted that the District lost millions of dollars in additional funds for ADAP over the past several years by failing to apply for federal Medicaid benefits for people with HIV that were already approved by the U.S. Department of Health & Human Services. News about the city's failure to obtain the Medicaid funds surfaced at a D.C. Council hearing on June 18.

Hawkins said the Medicaid benefits, which remain available for D.C. in 2004, would allow the city to arrange for hundreds of AIDS patients - many of whom are enrolled in the ADAP program - to have all of their medical and prescription drug expenses covered by Medicaid. This would remove these recipients from the ADAP program, freeing up their places in the ADAP program for other qualified recipients or making available additional funds to be used to pay for new drugs, such as Fuzeon, Hawkins said.

The District ADAP program does not have a waiting list of applicants at this time.

MORE INFO

HIV/AIDS Administration

717 14th St., NW, 10th Floor

Washington, DC 20002

202-727-2500

030627
WB030605

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