Revising ADAPs to treat sickest first makes ethical, economic sense
Time to switch from first-come, first-serve system?
There is an obvious ethical reason why AIDS Drug Assistance Programs (ADAPs) should prioritize client services according to treating the sickest first. However, a researcher also finds a public health and economic reason for such a change.
Prioritizing ADAP funding to give drugs first to the people who are the sickest gives ADAPs the most bang for their bucks, and it creates public health benefits, Benjamin Paul Linas, MD, MPH, an instructor in medicine at Massachusetts General Hospital and instructor in medicine at Harvard University, both in Boston, MA.
"The take-home message is to not postpone therapy and think it'll be okay," Linas says. "By far, the best policy is to fund ADAP adequately so that everyone in the U.S. can get it."
Linas is the principal investigator of a study that uses a Discrete Event Simulation (DES) model of ADAP to track the progression of HIV-infected patients. The model created a waiting list for care when the simulated ADAP's demand exceeded capacity and predicted incidence of opportunistic infections (OIs) and mortality.1
The study found that when facing excess demand, ADAPs can minimize morbidity and mortality by prioritizing patients based on their having low CD4 counts rather than on a first-come, first-serve basis.
"What we looked at was a situation in which an ADAP is underfunded, coming up short and not able to provide antiretroviral therapy (ART) to everyone clinically eligible," Linas says. "So what is the best way to prioritize patients?"
If someone has to be on a waiting list, then it's better that the people who have the least advanced disease are the ones who have to wait for drugs, Linas adds.
"It's a common sense approach, and while no one is surprised to see that a CD4 count-based approach does better, nobody does it," Linas says.
This approach to prioritizing ADAP services also is the more ethical approach, says Gordon Nary, executive director of the AIDS Drug Assistance Protocol Fund of Chicago, IL. the fund receives private grants to do policy work related to ADAP funding.
"It's a fundamental ethical issue," Nary says.
States that do not prioritize their ADAP clients based on the severity of their HIV illness hold some responsibility for what happens with ADAP clients grow sicker or die while on an ADAP waiting list, Nary adds.
"People don't look at ethical challenges unless there's an economic justification, which [Linas'] study provides," Nary says.
There are guidelines for prioritizing clients on ADAP waiting lists, but the new research suggests that similar standards would be advisable for prioritizing all ADAP clients, and not just those who are on waiting lists.
Ideally, all states would adequately fund ADAP so that there never were waiting lists, but that has not been the case.
'No one wants anyone to die on a wait list'
As of Nov. 25, 2008, there were 53 people on ADAP waiting lists in three states — Indiana, Montana and Nebraska, according to the latest ADAP Watch report issued by the National Alliance of State and Territorial AIDS Directors (NASTAD).
Since NASTAD began tracking ADAP waiting lists in mid-2002, there have been 20 ADAPS with waiting lists at some time or another. The highest number of people waiting to receive antiretroviral drugs was reported in May 2004 when 1,629 people were on state waiting lists, the NASTAD report says.
State ADAPs have tried to find ARTs through pharmaceutical company donations and other programs for clients even while they're on waiting lists, but this is doesn't work as a policy situation, Linas notes.
"No one wants anyone to die on a wait list, so people find whatever they can to get someone ART," he says. "From a policy perspective, it seems problematic to rely on case-by-case compassionate use."
For the purposes of the study, the model made the assumption that if someone was on a waiting list the person couldn't get AIDS drugs, Linas adds.
"There are many ways to access antiretroviral drugs," says William Arnold, director of the ADAP Working Group of Washington, DC.
"However, the principle of 'treat sickest first' remains ethically sound," Arnold says.
"If an ADAP has the medical information, staff and administration, and technology in place to actually evaluate the HIV disease stage on applying patients — and this will vary widely in 56 different ADAP programs — it could be feasible," Arnold says.
"The main burdens are going to be administrative burden and records and systems capacity," Arnold says. "ADAPs were designed to pay bills for antiretrovirals for eligible patients — assuming adequate funds from the federal government and local jurisdictions are available."
If ADAPs have to begin doing medical evaluation duties, it is going a bit beyond their original administrative mandate, Arnold adds.
Arnold and other ADAP officials have discussed making a policy change to promote ADAPs treating the sickest clients first.
"Most think the principle should be strongly stated," Arnold says. "But we acknowledge that until ADAP access is an entitlement, rather than a discretional set of funding streams — getting it integrated into 56 different, locally-organized ADAP funding streams is a real challenge."
Also, Arnold and other ADAP advocates have routinely called for increased federal ADAP funding over the past decade. As the number of people living with HIV/AIDS increases in the United States, the demand for ADAP also goes up, which is why there have been ADAP waiting lists each year of the 21st century.
The Congressional Black Caucus Health Braintrust sent a letter to the U.S. House Speaker Nancy Pelosi on Dec. 30, 2008, requesting full funding to end ADAP waiting lists.
"It is estimated that the cost of this would be approximately $300 million over the years 2009 and 2010, and is supplemental to the estimated 2009 appropriations request," the Congressional Black Caucus Health Braintrust letter states.
"This program has been grossly underfunded for the past five years, and has resulted in intermittent care which gives rise to resistance and deaths of clients who could not receive treatment," the letter states. "Because people of color make up more than half of all HIV and AIDS cases, racial and ethnic minority communities are the most adversely impacted by the shortfalls in this vital program."
ADAP funding improves when the consequences of underfunding are made apparent, Nary notes.
Picture of death
In January, 2004, the AIDS Drug Assistance Protocol Fund published the Journal of Timely and Appropriate Care to highlight issues related to ADAP funding and waiting lists. The cover of the journal featured the bottoms of a man's feet with a toe tag indicating he had been on an ADAP waiting list, Nary says.
"We sent that to every state and legislature and AIDS organization in the country," Nary says. "That issue had a profound impact on actions to resolve the waiting list program primarily because of the picture of the body in the morgue."
ADAP waiting lists peaked in May, 2004, but have fallen considerably since then, according to NASTAD's ADAP Watch report.
However, there are signs that the waiting list will rise again this year, Nary says.
"The threat we may have is a major jump in the amount of new HIV cases this year," Nary says. "Data may be under-reported in the African American community, and a lot of people are anticipating a major jump in ADAP registration, depending on how effective the big push is for more testing, especially in the African American community."
What might prevent a spike in ADAP waiting lists is if President Barack Obama makes HIV/AIDS a priority both with funding requests and by appointing a national AIDS director, Nary says.
At the very least, the federal government needs to fund a pilot project that uses the sickest-first priority method in a state with a large HIV population, Nary says.
"You need to test this model in a large state where you can have larger numbers to work with," Nary explains.
If successful, the model would provide the economic justification states need to make the change away from a first-come, first-serve priority system.
From state ADAPs' perspective, the challenges of making the switch in how ADAP clients are prioritized include the typical resistance to change and the headaches of setting up and training staff on a new computerized model, Nary says.
"You're talking about setting up a new system where there has to be qualifications reported and kept updated and CD4 counts collected," he says. "You need new training on how to use it, and you need to get physicians to use it."
It will add expenses to already strapped ADAP budgets, so there might need to be federal funding for its implementation, Nary adds.
This new model would be an evolutionary change for ADAPs, Nary says.
"The positive benefits are that this is the most ethical way to prioritize ADAPs," Nary says. "The current system violates that basic physician's principle of not doing harm because it has done harm and has the potential of doing more harm in the future."
- Linas BP, Losina E, Rockwell A, et al. Optimizing outcomes in US AIDS Drug Assistance Programs. Abstract presented at the Annual Meeting on Infectious Diseases hosted by the American Society for Microbiology and Infectious Diseases Society of America, held Oct. 25-28, 2008, in Washington, DC: Abstract: H-446.