GMHC Treatment Issues, Vol. 10, No. 2; February, 1996
Derek Link

ADAPs are the most heavily utilized AIDS programs in the nation, with over 50,000 people with HIV or AIDS enrolled. The federally funded ADAP system began in 1987 as a way of providing free AIDS drugs to low- or moderate-income people not covered by Medicaid or third-party insurance. Since 1990, ADAPs have been funded by the Ryan White CARE Act, the main source of federal funds for AIDS care. Each state administers its own ADAP, so eligibility criteria and formularies (the list of covered drugs) vary from state to state. Some states, like New York, have run generous programs that cover most AIDS-related medications, while other states have restrictive programs that cover only a few (usually AZT, aerosolized pentamidine and Bactrim).

The Gathering Storm

In the last several months, two state ADAPs (Colorado and Missouri) have run out of money and others have cut services, limited enrollment or canceled formulary expansions in the face of growing budget shortfalls. The budget problems with the ADAPs appear certain to grow in the coming fiscal year as new protease inhibitors gain FDA approval and multi-drug combination therapies are prescribed earlier in disease, increasing the cost and use of antiretroviral drugs.

Use of antiretroviral agents has increased dramatically over the last twelve months, following a period of decline after the Concorde study results in 1992. In New York State, for example, expenditures on antiretroviral drugs from fiscal year 1993 to 1996 are projected to almost double, rising from $5.9 million to $11.2 million. 3TC is one significant case.

Twelve hundred people obtained 3TC through New York ADAP in the month following its approval in November, and the state ADAP spent $300,000 on the drug in its first month alone. The demand for 3TC represented a record level of interest in a new therapy. 3TC, which is used mostly in combination with AZT, is also associated with increased AZT expenditures.

The National Association of State and Territorial AIDS Directors (NASTAD), a lobbying group, surveyed state ADAPs in January. Forty-two states responded to the survey. NASTAD found nineteen state ADAPs had or will have budget shortfalls this fiscal year. The budget gaps ranged from $5.9 million in New York to $15,000 for Nebraska. NASTAD calculated that a total of $12 million would be needed just to make up the budget gaps this fiscal year. States have implemented a variety of measures to reduce ADAP expenditures, the most common of which are delaying or canceling formulary expansions (twelve states), removing drugs from the formulary (seven states) and establishing waiting lists (seven states).

New York Cuts Back

On January 1, New York State implemented drastic cost-cutting measures for its ADAP. Over 70 percent of the drugs covered by New York ADAP have been eliminated from the program, including critical medications such as Neupogen, Epogen and many antibiotics. In addition to the cuts, New York ADAP is unable to cover any new therapy. Saquinavir, the first approved protease inhibitor, is not covered, and other new protease inhibitors will not be covered when they receive marketing approval later this year.

Despite the budget problems, interest in protease inhibitors remains high in New York State. New York ADAP administrators say that they have received approximately 120 phone calls a week asking for saquinavir since it was approved late last year. New York State's Clinical Advisory Committee for HIV Uninsured Programs, which advises ADAP on clinical issues, this month recommended protease inhibitors be covered by ADAP but not at the expense of other cuts in the program. With more cases than any other state, New York is the epicenter of the HIV/AIDS epidemic. New York's ADAP is accordingly the largest in the country. Since its inception, New York ADAP has covered over 32,000 New Yorkers with HIV. Its current enrollment exceeds 10,000. About 70 percent of New York ADAP recipients live in New York City, and over 60 percent earn less than $10,000 per year. Seventy-five percent of NY ADAP participants use the program while their Medicaid applications are being processed, which often takes six months, and the remaining 25 percent are uninsured or underinsured.

New York State estimates it needs $49 million in 1996 to maintain ADAP at its current reduced level. The state will need an additional $9 million to keep the current level of service while adding the protease inhibitors. Seventy-five million dollars is required to restore all cuts and add the protease inhibitors, too.

Lobbying For ADAP

The ADAP funding shortfall has led AIDS organizations to press for more funds at the state and federal level. Nationally, funding for ADAP is part of the debate on reauthorization of the Ryan White CARE Act. The CARE Act is stalled in committee, and many AIDS lobbyists worry that it may remain stalled because the 104th Congress has had a very difficult time passing any legislation. If the CARE Act is not reauthorized soon, an even deeper funding crisis may occur in all CARE Act programs, including the ADAPs. In any event, NASTAD and other groups have called on the Congress and the Administration to increase the CARE Act appropriation for ADAPs. An "ADAP Future Funding Working Group" has also formed in Washington. This working group is composed mostly of lobbyists who represent the companies that make and sell medications for AIDS and HIV.

The Health Resources Services Administration (HRSA), the federal office that administers Ryan White programs, is also developing a national "core formulary" for ADAPs. The goal is to standardize ADAP coverage in all states so that an even level of service can be provided nationwide, among other things allowing for more accurate planning. HRSA expects to have elaborated the "core formulary" by early summer.

In New York State, a group of AIDS organizations and legislators have joined together in a campaign to save ADAP. The New York State group is pressing the government in Albany to supplement the ADAP budget with state funds -- right now, New York uses none of its own funds for ADAP. A bill that would use state funds to fill any shortfall in the state ADAP budget has 31 sponsors in the Assembly but has yet to be introduced in the Republican-controlled Senate.

State funds do subsidize ADAP in California, where ADAP is running a $4-8 million deficit and is estimated to need an extra $18 million annually just to maintain current service and add 3TC and saquinavir. Activists are trying to gain extra budgetary allocations. At the same time, they fear bringing ADAP to the attention of the new conservative Republican majority in the state Assembly.

Two-Tiered Access

ADAP's woes underscore a frightening reality in the American health care system. More and more people with HIV who rely on government health care or managed care plans may find that newer and more expensive drugs remain unreimbursed.

Breakthrough drugs that have a major life-prolonging potential for people with HIV, like protease inhibitors, may only be available to the very few who have jobs that offer top-of-line insurance coverage. A concerted effort is still needed for comprehensive health care reform, but in the meantime AIDS groups must focus attention on the growing numbers of persons with low and even moderate incomes who cannot gain access to protease inhibitors and other innovative HIV therapies.
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