ADAP Wars Heat Up
The ADAP wars continue to heat up. Over the skies of a nation that saw AIDS cases rise by 8 percent last year after seven years of steady decline, AIDS funding estimates fly like SCUD missiles. Some hit targets. Others miss.
As of January 2002, AIDS Drug Assistance Programs (ADAP) in the 50 states were serving more than 125,000 -- or one in three on treatment -- nationwide. Each month, 670 new clients seek enrollment. Worldwide AIDS is responsible for 8,500 deaths each day. Against this backdrop, Big Pharma raises drug prices both domestically and internationally.
Finally, an elected official goes ballistic. U.S. Congresswoman Diane Watson (D, California) and AIDS Healthcare Foundation, the country's largest HIV/AIDS medical provider, urges merged behemoth GlaxoSmithKline (GSK) in a multi-pronged February media campaign to "Do the Right Thing!" by lowering drug prices.
"According to the World Health Organization, over 8,500 adults and children around the world die from AIDS every day," says Congresswoman Watson. "When we have so many potentially life-saving AIDS drugs available today, this is truly a tragedy -- the tragedy of AIDS that one South African newspaper recently editorialized as 'the new apartheid: pernicious, genocidal and bureaucratic.'"
"It is time for GlaxoSmithKline to lower their prices and cut the red tape for their HIV/AIDS drugs for Africa and the world," says AIDS Healthcare Foundation (AHF) president Michael Weinstein. "GSK's so-called 'preferential pricing' for the developing world is little more than newspaper headlines -- the reduced prices bring drug regimen costs close to $2,000 per patient per year -- a price virtually no individual or government in the developing world can afford."
AHF and Congresswoman Watson want GSK to reduce their prices further so that per-patient costs per year are approximately $500 for a drug regimen that would utilize GSK's brand-name HIV medications. Further pressure to lower prices mounts from data indicating generic versions of such drugs, as explored by Medecins Sans Frontiers/Doctors Without Borders for countries such as South Africa, may cost as little as $150 per patient per year, according to that organization.
At ground level where HIV disease works its hideous process in the bodies of ordinary people, seven US states already have "waiting lists" for their ADAPs. Exacerbating the problem is the fact that for a second year in a row, President George W. Bush has "flat funded" the Ryan White CARE Act programs at $1.9 billion for fiscal year 2003. The life-saving program for thousands of HIV-positive individuals across the nation, known federally as the AIDS Drug Assistance Program (ADAP), will receive $639 million -- the same amount as in fiscal year 2002. No church-based organizations are lined up to offer help -- with or without federal dollars.
"Currently, there are about 700 individuals on ADAP waiting lists nationally, according to Arnie Doyle, National Alliance of State and Territorial AIDS Directors (NASTAD). According to another national advocacy organization known as Title II Community AIDS National Network, or T-II CANN, state programs with waiting lists include Alabama, with 300 individuals waiting for access to life-saving HIV/AIDS drugs. In Arkansas and North Carolina, the actual number of clients waiting for medicines is unknown. Georgia has 274 potential clients waiting in the wings. Indiana has 60. In Maine, 22 clients are currently waiting for access to protease inhibitors. By early 2002, Kentucky expects to have a waiting list. In response to the budget shortfalls and under-funding, another seven states expect to institute waiting lists and/or other to restrict access early in 2002. Those states are Idaho, Florida, Missouri, Nevada, Oregon, Rhode Island, and West Virginia.
"Given that the ADAP appropriations for FY2001 and FY2002 were well below estimated need, we do expect to see additional states implementing access restrictions, including capping enrollment or limiting formulary expansions by mid-FY2002 which means, in calendar time, about August, September 2002," Doyle says.
A review of Bush's budget for fiscal year 2003 shows that he allowed for a 2 percent increase in non-defense spending, 1 percent less than last year's budget, according to NASTAD. Programs aimed at domestic HIV/AIDS prevention, care, and treatment programs did not fare well (see "Proposed 2003 Bush Budget 'Flat Funds'" below), although there may be increases for the National Minority HIV/AIDS Initiative (NMHAI) incorporated into the budget.
Despite alarming HIV/AIDS allocation numbers for fiscal year 2003, the budget process is only beginning. With release of the budget early February, NASTAD sounded the alarm by calling on patients and activists to "relay to congressional delegations the impact of flat funding on state HIV/AIDS programs." The organization is working with U.S. House and Senate appropriations staff to ensure that increased funding levels are included in the final budget package. "State AIDS programs will have many opportunities to weigh-in and turn this devastating funding picture around," notes the organization's press release on the topic.
Washington-based organizations like the ADAP Working Group, a coalition of community-based organizations and drug companies, will insure that everyone in Washington involved in the process, according to the group's chair William Arnold, will hear about the problem. In a town where numbers are cooked to say anything, Arnold assures stakeholders that decision-makers will "get accurate facts about the ADAP funding crisis." "But only tons of calls, letters, faxes from folks 'back home' make our political leaders step up and take action," he cautions.
Arnold explains that former President Bill Clinton's last budget (fiscal year 2001) started ADAP's downward spiral by "under-funding the program by $50 million of much-needed money." He notes further that the 2002 fiscal year budget, President Bush's first and for which ADAP funds will be released on April 1, 2002, "is an additional $60 million short of ADAP's documented, actual need," adding that "All state ADAP programs are very concerned. Our forecast now shows an immediate need for an "Emergency Supplemental ADAP appropriation" of $82 million and for an additional $82 million in the 2003 fiscal year budget. Arnold says that not only do ADAPs need $164 million, "but we need $82 million of it now."
As funding scenarios go, Arnold points out that the current levels of funding have to last ADAPs until March 31, 2004. "That's a long time with hundreds of people already starting to pile up on waiting lists for treatment they need right now, today," Arnold laments. "It's one kind of tragedy to have HIV-positive Americans dying at the rate of 40,000 a year when we had no treatments. Many of us remember the pre "combination therapy" days very well. It is very much another kind of second-hand murder to allow HIV-positive people to start dying prematurely again due to under-funding when we finally have effective treatments," Arnold says.
"The American communities affected by AIDS should not tolerate medicines not getting to sick people who can't get -- or can't afford -- adequate health insurance. Our political system should not be allowed to tolerate this kind of neglect either. We have ADAP to fill this healthcare gap. ADAP must be funded to do its job. It's time for a lot of us to wake up and start letting the world know that denying access to treatment to HIV-positive people is simply not acceptable American behavior," Arnold says.
The States of New York, New Jersey, and Connecticut report different experiences in the face of funding shortfalls and flat funding by the White House.
With an estimated 46,781 individuals living with AIDS in the State of New York, the state assists 18 percent of the nation's total number of known AIDS cases. For all of its HIV/AIDS services, the state spends $2.3 billion, according to communications office representative Kristine A. Smith.
Officials there expect to see a rise in the number of AIDS cases enrolling in their programs. "In part because of the extensive HIV health care services New York provides," Smith says, "we expect the number of persons living with HIV/AIDS in New York to increase over the next three to five years."
She cites several reasons for the increase. "First, the rate of new HIV infections is believed to have remained constant for a number of years and is expected to continue for the future. Second, since 1996 the use of combination antiretroviral therapy has reduced by about 80 percent the number of AIDS deaths. Consequently, many HIV-positive individuals live longer. However, adherence to drug therapy, known as HAART or highly active antiretroviral therapy, must be very high in order to avoid HIV viral resistance and the development of resistant virus. The development of resistant HIV virus due to non-adherence to a drug regimen eventually will result in HIV-positive individuals progressing to clinical AIDS."
Smith does the math and concludes that with "a flow of new HIV-positive individuals, a portion of whom will progress to AIDS, and fewer patients who adhere to HAART dying from AIDS, we will see a net increase in persons living with AIDS." The net result for New York's ADAP is that the current number of 16,567 enrolled individuals will rise. For 2001, a total of 22,116 persons were enrolled at some point during the year. For some individuals with access to HIV drugs, the issue isn't adherence. The issue is that the drug combinations stop working.
Smith's "waiting list" answer is hopeful. "New York does not have, nor ever has had, a waiting list for ADAP." In the state's current fiscal year, which begins April 1 2002, New York ADAP expects to spend $167 million for drugs. These drug costs are funded by a combination of Ryan White CARE Act Title II funds to the state, Title I funds contributed by the metropolitan areas or EMAs (New York City, Lower Hudson, Long Island and Dutchess County), state funds from the Health Care Reform Act, and rebates and insurance recoveries. "This level of funding has been sufficient to provide all ADAP enrollees with access to a formulary of more than 400 drugs," Smith points out.
Even with such extensive programming, Smith warns of a "deficit." "The increase in federal funds for the next fiscal year, beginning in April 2002, will not be adequate to meet the consistent annual growth rate that ADAP has experienced for the past several years. This situation will result in a "structural deficit" whereby the annual appropriations by themselves are not sufficient to meet the need," Smith notes.
However, New York has anticipated and planned for this situation. Increased contributions from the Title I metropolitan areas have been sought and agreed to. In other HIV program areas where efficiencies have resulted in savings, those savings have been earmarked for transfer to ADAP. Also, ADAP hopes to generate savings in the current fiscal year that can be used next year when needed. "We are cautiously optimistic that this action plan will allow New York to maintain service levels in the next fiscal year," Smith says, concluding that the actions planned will resolve the structural deficit for 2002 fiscal year.
Currently in New Jersey, there are approximately 4,000 individuals enrolled in that state's ADAP. "Enrollment has been relatively stable at this level for the past 18 months and is not expected to change significantly over the next 12 months," according to Marilyn Riley, New Jersey Department of Health and Senior Services. Unlike other states' programs approaching budgetary "red," New Jersey's program "does not anticipate a budget shortfall at this time," Riley says. In fact, as of January, New Jersey ADAP expanded its drug formulary to cover all prescription medications.
Although Riley says she "does not anticipate any major changes over the next year, within the next several years, there will likely be new classes of AIDS medications that will impact on treatment regimens and ultimately ADAP expenditures." She notes that "the major challenge over the next three to five years will be providing access to new medications while maintaining the program's financial solvency."
Not all state-run ADAPs are hurting. According to Connecticut's ADAP director Richard C. Lee, that state's program, known as CADAP, is running a surplus of "about $2.8 million." Currently, about 1,100 clients are enrolled. "CADAP still has a lot of room for growth in enrollment numbers," he says. Lee points out that "due to the budget surplus, we are not anticipating a waiting list, or any restrictions on eligible clients." Because of the surplus, Lee's program plans to systematically expand the formulary in order to eliminate the surplus and to provide more comprehensive pharmaceutical benefits for clients. As of March , the program added an additional 14 drugs: Benztropine Mesylate (Cogentin), Bupropion HCL (Wellbutrin), Buspirone (BuSpar), Cidofovir (Vistide), Clonazepam (Klonopin), Famciclovir (Famvir), Fluoxetine HCL (Prozac), Guaifenesin/Codeine Phosphate (Tussi-Organidin S-NR), Guaifenesin/Dextromethorphan HBr (Tussi-Organidin DM-S-NR), Levothyroxine Sodium (Synthroid), Mirtazapine (Remeron), Risperidone (Risperdal), Strovite Forte, and Tazodone.
In whatever state an HIVer lives, up-to-date information on your ADAP is essential to making informed choices, especially if elected officials are flagging on their funding commitments. If "flat funding" continues, Doyle foresees that "domestic HIV/AIDS programs over the next few years will begin to crumble." He has "little doubt that the reductions in HIV/AIDS-related morbidity and mortality would quickly reverse themselves."
"With gains made in reducing HIV/AIDS morbidity and mortality, with the cost-effective investments made in public health systems, not to mention the immense reduction in human suffering, something that is difficult to quantify," Doyle says, "now is not the time for our nation to pull back on its commitment to domestic HIV/AIDS care and prevention programs. We must increase our commitment to HIV/AIDS prevention and care programs domestically, while increasing our commitment to the international battle against HIV," he concludes.
Back to the July/August 2002 issue of Body Positive magazine.
This article was provided by Body Positive. It is a part of the publication Body Positive.