On behalf of the International Association of Physicians in AIDS Care (IAPAC), I would like to welcome each of you to our association's first summit on the issue of AIDS drug access in the United States. The summit will examine public and private sector provision of HIV/AIDS care, specifically antiretroviral therapy, as well as the issue of drug pricing.
We live in one of the best of times with regard to access to antiretroviral therapy; with 19 US Food and Drug Administration (FDA)-approved antiretroviral drugs and three fixed-dose combinations. We know that highly active antiretroviral therapy (HAART) has led to dramatic declines in AIDS-related mortality. In fact, where 50,000-plus individuals died of AIDS-related causes in 1995, we witnessed a steep decrease to 16,000-plus deaths in 2002 -- and we know that this "miracle" is a direct result of HAART.
Regrettably, this is also among the worst of times in that an expanding antiretroviral drug armamentarium, while providing choices to patients and their care providers, creates an incredible financial strain on those systems that currently exist to guarantee access to people living with HIV/AIDS, especially the medically indigent. There are serious concerns about the additional expense of and about the price points for antiretroviral drugs at various stages of development, including Boehringer Ingelheim's new protease inhibitor, tipranavir (TPV). This at a time when a growing number of Americans living with HIV/AIDS find themselves on waiting lists for AIDS Drug Assistance Programs (ADAPs) because of state and federal budget shortfalls, or must deal with one or more drastic restrictions in access to life-saving medications through their state ADAPs. And this is all compounded by sobering statistics telling us of increased HIV prevalence among un- and under-insured Americans.
Lanny Cross, Program Manager of New York State's ADAP, will speak about his experience in these difficult times. The 50-state ADAP network currently serves approximately 89,000 individuals who are low income, un- or under-insured, and non-Medicaid eligible. As of January 30, 2004, nine states had ADAP waiting lists with almost 800 people on those lists. Six other states had implemented some type of restriction. According to recent modeling estimates, we know that a minimum increase of US$217 million is needed in fiscal year 2005 to support state ADAPs nationally; US$121.7 million of that is needed immediately to address accumulated funding shortfalls over several years.
The private sector is also feeling a financial squeeze, what with a significant per capita growth in prescription drug spending. Michael Allerton, HIV Operations Policy Coordinator of the Permanente Medical Group at Kaiser Permanente will explain the already existing and soon-to-come restrictions on private sector AIDS drug coverage, to include formulary restrictions, prior authorizations, and multi-tier co-pay arrangements.
This one-day summit is meant to address both the economics and the ethics of AIDS drug access. Because IAPAC infuses all of its meetings with ethics, the necessary balance of economics and ethics around this public health challenge will be examined. On the economic side, the cost of prescription drugs is reflective of the need to recapture research and development (R&D) investment, and that argument will be presented by Joshua Cohen, Senior Research Fellow at the Tufts Center for the Study of Drug Development. He will also demonstrate in cold, hard numbers another economic reality: that the public and private sector actors charged with guaranteeing AIDS drug access are struggling to keep pace with demand. On the ethical side, I am certain that our discussions will reinforce the notion that, for example, drug pricing decisions must be made within the context of a moral duty to assist those in need. Our obligation is to provide more than succor to people living with HIV/AIDS, especially because we know beyond a reasonable doubt that early HIV treatment saves both lives and money. It is thus necessary to provide such treatment universally through various mechanisms, including the Early Treatment for HIV/AIDS Act (ETHA) currently before the US Congress.
This summit is not about blaming the pharmaceutical industry for the entirety of the problem. Certainly drug pricing is a concern. But there is an additional need for increased funding from federal and state governments. Increased collective price negotiations efforts are critical, as is a broader systems approach to prescription drug access and funding. And, obviously, thought needs to be given to regulation through reference pricing and the enhancement of cost relocation schemes such as the ETHA.
A dose of reality is necessary in everything that we are addressing today. The business of manufacturing pharmaceuticals is based on a free-market system, and profitability remains a key incentive. But, we need to look at a mixed basket of solutions if we are to make any progress in an era when we are experiencing severe economic constraints on both the public and private sectors. Thus, industry profit concessions, prescription drug system reviews and amendments, increased but targeted federal and state ADAP funding, and increased attention to private insurance coverage must be on the table as we cobble together our strategy to maintain and expand AIDS drug access in the United States.
The key, I believe, is open and participatory dialogue. I am thus pleased that contributions from representatives of various sectors are included: we count on the participation of people living with HIV/AIDS and their advocates, physicians and allied health professionals, AIDS service organizations, government officials, insurance company decision-makers, and pharmaceutical company representatives.
Why the mixed-basket approach to arriving at solutions? Because we need to ensure the sustainability of our efforts to guarantee AIDS drug access to Americans living with HIV disease. This is an argument IAPAC is advancing on several different fronts as we attempt to expand access to antiretroviral therapy in the developing world. It is no less important here in the United States, especially in light of the cruel reality that there are hundreds -- and there may soon be thousands -- of people living with HIV/AIDS in this country who today do not have access to life-saving and -enhancing antiretroviral therapy.
Christine Lubinski, Executive Director of the HIV Medicine Association (HIVMA), provides an overview of AIDS drug access in the United States. My hope is that her presentation will provide a framework from which we can derive context for an examination of the pharmacoeconomics of HIV treatment -- which is covered in a presentation by Patrick Clay, Assistant Professor of Medicine in the Division of Pharmacy Practice at the University of Missouri-Kansas City. And, to keep us focused on what our advocacy is all about -- the care of men, women, and children living with HIV/AIDS -- we are pleased to count on the participation of Benjamin Young, an IAPAC physician member and Clinical Instructor in the Department of Medicine at the University of Colorado Health Sciences Center. He will deliver IAPAC's call to action around AIDS drug access.
Our ultimate objective is to develop some recommendations for advancing a far-reaching advocacy and legislative agenda to expand AIDS drug access in the United States, as well as strategies for public and private sector influence on AIDS drug pricing; again, with an eye toward the future. There are certainly contentious issues with which we have dealt in recent months and which merit discussion, specifically Abbott Laboratories' decision to implement a 400 percent price increase for its protease inhibitor, ritonavir (RTV). Yet, I am hopeful that today's summit will include a healthy dose of forward thinking aimed at securing the future of AIDS drug access in the United States.
José M. Zuniga is President/CEO of the International Association of Physicians in AIDS Care.
Back to the May 2004 Supplement issue of IAPAC Monthly.