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Will the safety net hold? New partnerships help
Patient influx 'an administrative nightmare'
With unprecedented numbers of HIV patients pushed onto waiting lists to receive antiretroviral (ART) drugs from AIDS Drug Assistance Programs (ADAPs), the bottom rung safety nets are barely holding, experts say.
In the past year, HIV service organizations and clinics with case managers who work to find ART funding for patients have been flooded with new cases to handle.
"For example, Virginia ran out of money, so they're shifting 650 people as we speak to patient assistance programs (PAPs)," says William E. Arnold, director of the CANN-Community Access National Network in Washington, DC.
Fewer than 12 clinics with maybe 15 case workers suddenly have to handle 650 additional clients. And Virginia's ADAP waiting list already topped 470.
"We know from local Virginia providers because they're a stone's throw from my office that people are falling through the cracks," he adds. "Having 650 people handed to patient assistance programs on a month's notice is an administrative nightmare."
Until recently this would be the end of the story. But a silver lining has appeared in the dismal domestic picture of HIV care and access during the Great Recession.
Last summer, the Heinz Family Foundation of Washington, DC, began to have a conversation with Abbott Laboratories of Abbott Park, IL, about emerging ART access problems among low income HIV patients, says Jeffrey Lewis, president of the Heinz Family Foundation.
"The problem with the ADAPs is that more and more of these people had not been shifted to a patient assistance program, and they should have been," he says.
PAPs are complex and bureaucratic, largely because of legal and regulatory obstacles.
"There is no single form to do a PAP," Lewis says. "There are multiple forms for multiple companies, which is inefficient and inhumane."
Plus, HIV patients each have multiple drugs that are manufactured by multiple pharmaceutical companies, and the same cumbersome application process has to be completed separately for each prescription.
"The paperwork alone is exhausting," Lewis says.
"If there was a single patient assistance program form that could be used across companies then it would make for easy administration," he adds. "We will go forth with pharma to create that, but it's not without legal pain: how do you make it operational, and how do you do it without an antitrust issue?"
A more immediate problem
And there is the more immediate problem of people infected with a deadly disease who suddenly are losing access to their life-saving medications.
The foundation's goal was to see if pharmaceutical companies, working with nonprofit organizations, could provide antiretroviral drugs for free to HIV patients who had lost their medications through ADAP and now were on waiting lists.
"We recognized that if we could move the private sector to come together to solve a national crisis then we could do it without interference," Lewis says. "Abbott immediately agreed to join the effort."
With Abbott on board, the Heinz Family Foundation spoke with Merck of Whitehouse Station, NJ, and then another company until all of the major ART manufacturers agreed to a new safety net program. They would provide free ARTs to all patients on ADAP waiting lists. In addition, the pharmaceutical companies, along with the Heinz Family Foundation, would provide funding to a pharmacy to handle the administrative cost of distributing the drugs where they were needed.
The foundation needed a pharmacy partner and found Welvista of Columbia, SC. A nonprofit pharmacy that was founded 18 years ago to provide free drugs to indigent South Carolinians with chronic diseases, Welvista had the infrastructure necessary to expand into the world of HIV medication. The pharmacy serves close to 20,000 clients who are at less than 200% of the federal poverty level. And the pharmacy already had experience working with pharmaceutical companies who donate medications for indigent chronic disease clients.
Since beginning this new partnership last summer, Welvista has expanded to sending medications to HIV patients on ADAP waiting lists in nearly all of the states with such lists, says Ken Trogdon, chief executive officer.
"We had a long-standing relationship with Abbott and Merck, so it was an easy push to get their products on formulary," he adds.The fourth piece to the puzzle was to convince ADAP coordinators to work with Welvista.
"If there's a state with an ADAP waiting list, their local ADAP coordinator faxes to us a prescription that we developed for patients on the waiting list," Trogdon says. "We fill the prescription and send it to the patient's home or clinic."
HIV clinics, providers, and case managers do not have to be involved. No one has to fill out paperwork, and patients do not have to wait longer than a few days for their medications. It keeps patients from having gaps in their treatment, Trogdon adds.
Welvista has been certified to provide the ART medications in nine of the 11 states, with still some work to go in Virginia and Louisiana, Trogdon says.
"They're more challenging, and we're still in the process of getting licensed in those states," he adds.
There are a few drawbacks to this approach, including the fact that most HIV/AIDS patients need multiple medications in addition to antiretroviral drugs. Many ADAP formularies include prescriptions for non-ART drugs, such as drugs to treat opportunistic infections and chronic diseases. But the Welvista program is limited to ARTs. HIV patients who are dropped from the ADAP role still will need to apply for patient assistance programs to receive their other medications.
Another issue is that states have been cutting their ADAP roles so quickly and through such a variety of tactics, including reducing eligibility requirements and other criterion that many HIV patients who were receiving ADAP drugs are not even eligible for being on the ADAP waiting list now. There is no easy answer for what will happen to these people since the Welvista program is restricted to providing medications to those who are on the ADAP waiting lists.
Also, it's uncertain what will happen to the program should the ADAP waiting lists decline as they have in the past.
"We're trying to have a conversation with companies about where this is going in the long term," Trogdon says. "I think folks on the waiting lists have been scrambling to find solutions, and this offers a seamless solution, but we don't know the impact it's going to have on a much larger level."
Pharmaceutical companies are committed to making certain that no HIV/AIDS patient uses an emergency room when it can be prevented, Lewis says.
"If we can adapt an ADAP solution, we can keep thousands of people from being forced to go to the hospital emergency department because they can't get the medications they need," he adds.