The latest AIDS drugs, praised as a breakthrough in treatment of the deadly disease, will double at very least the cost of drug therapy, further straining vulnerable government programs.
AIDS advocacy groups are pooling their might to battle for additional public money to cover the new drugs, known as protease inhibitors. Without new funds for the poor, the treatment and health of insured and uninsured patients will diverge more sharply, said Martin Delaney, founding director of Project Inform in San Francisco.
HMOs, in turn, are readying for considerable increases in their AIDS drug budgets. But they expect to pay for fewer and shorter hospital stays as a result of better drug therapy.
"What is happening now is the most important breakthrough in the history of the epidemic," said Michael Weinstein, president of the AIDS Healthcare Foundation in Los Angeles. "This may be the beginning of HIV becoming a chronic manageable disease, although we're not there yet."
There is optimism that protease inhibitors, despite steep prices, will reduce the total cost of treating people with AIDS and HIV, the virus that causes AIDS, by prolonging productivity and decreasing hospitalizations.
Studies show protease inhibitors combined with older drugs significantly lower viral RNA levels, a measure of the amount of HIV in patients' blood. The degree to which they increase lifespan and improve other outcome measures isn't established.
The first protease inhibitor, Invirase by Hoffman LaRoche, was approved by the Food and Drug Administration on Dec. 7, 1995. Its annual wholesale price is $5,800. Abbott Laboratories recently applied for FDA approval to market a second protease inhibitor, and Merck & Co. is expected to file a request for its own drug shortly.
Protease inhibitors are used in conjunction with older drugs, such as AZT and ddC. The older drugs, known as nucleoside analogues, attack an enzyme involved in the replication of genetic material. Protease inhibitors also try to block the replication of HIV, but they target a different enzyme.
The combination is much more potent than previous therapies. "We'll probably end up giving not only double combination therapy but also triple combination therapy," said Alberto Avendano, M.D., executive director of the Florida AIDS Action Counsel. "But these are going to keep people healthier longer, and I think the investment is going to be worth it."
At the AIDS Healthcare Foundation, treatment of an asymptomatic HIV-positive person has cost $3,500 to $5,000 annually. That will double at least due to new combination therapies, Weinstein said.
The foundation cares for 2,600 people with AIDS and HIV, about 400 of whom are covered by a capitated contract with Medi-Cal, the state Medicaid program (Oct. 30, 1995, p. 50). The capitation rate, however, will rise to reflect new treatments, Weinstein said.
Medi-Cal plans to include protease inhibitors in its formulary, but it hasn't estimated how much drug expenditures will rise, an administrator said. Other payers are in similar circumstances.
"The Invirase drug is not going to take the place of any other drug, so costs are going to go higher, but we really have no way of estimating the actual impact on our budget," said Clifford Chen, a pharmacy manager at Kaiser Permanente Los Angeles Medical Center.
Medicaid programs cover about half of AIDS patients, according to estimates. Increased spending for AIDS drugs will seem minor in light of already massive drug budgets.
The programs in financial jeopardy are AIDS Drug Assistance Programs, or ADAP, activists said. ADAP programs are largely funded under the federal Ryan White Comprehensive AIDS Resource Emergency Act of 1990. They don't necessarily get more money just because new, more expensive drugs are available.
Up to 30% of people with AIDS and HIV don't have insurance, said Christine Lubinski, deputy executive director of the AIDS Action Council, Washington. ADAP programs may be their only source of coverage.
"We are hearing that at least half a dozen ADAP programs have gone broke and that many other states are so concerned about the solvency of their ADAP programs they are reluctant to add protease inhibitors," Lubinski said.
"What makes this particularly horrifying is what is expected to happen to Medicaid," she said. "Our concern-and we've been working all year to protect the Medicaid program-is that even under the best case scenario, (states' inclination) will be to eliminate reimbursement for optional programs, such as prescription reimbursement. What good are all these drugs if only a minute population can access them?"
A year's supply of the first approved protease inhibitor, Invirase, will have a wholesale cost of about $5,800. Current drugs run $2,000 and more annually.
Drug expenditures will rise considerably because new drugs won't replace old drugs, experts said. Instead, physicians will prescribe two- and three-drug combinations.
More than half of AIDS patients, or about 100,000 people, depend on Medicaid for healthcare, according to the Office of National AIDS Policy.
Public programs spent about $3.8 billion in 1994 for healthcare for people with HIV and AIDS, according to the Henry J. Kaiser Family Foundation. About 70% was Medicaid money and about 15% was funded by the Ryan White Comprehensive AIDS Resource Emergency Act.