A Pharmaceutical Safety Net

HIV-positive patients who need expensive antiretroviral medications but have no health insurance, do not qualify for public medication programs, and cannot afford the five-figure price tag for an anti-HIV drug cocktail have an unexpected last-resort option: pharmaceutical companies themselves. Every brand-name drug company in the United States operates a patient-assistance program that provides free drugs to HIV patients who 'slip through the cracks of other programs,' says Mark Grayson, deputy vice president of the industry organization Pharmaceutical Research and Manufacturers of America. 'It's been a long-standing practice' for companies to provide free drugs to people who cannot afford them, Grayson says, starting with making free samples widely available to physicians for low-income patients in the 1950s up to the more formal access programs organized in the 1980s and 1990s. All of these programs offer anti-HIV medications, Grayson adds. Some are even expanding their scope, as state-run Medicaid and AIDS Drug Assistance Programs are tightening financial eligibility requirements or implementing waiting lists to deal with budget shortfalls. For example, Gilead Sciences announced in April expansion and simplification of its program, called Commitment to Access, to enable any HIV-positive adult who meets program criteria to have immediate access to free antiretrovirals on the same day they receive prescriptions for Gilead's anti-HIV drugs. 'Expedited access to therapy is especially important in the field of HIV, where patients are often not diagnosed until they are quite ill,' company president John C. Martin says. Abbott Laboratories maintains a patient-assistance program for all its medications but has revamped the program for Norvir, one of its protease inhibitors, after the company raised the price of the drug by more than 400%. The new Norvir program provides the drug free to anyone without private or public health insurance regardless of annual income or financial status, according to company spokeswoman Nicole Wesley. Because each company's patient-assistance program maintains different eligibility requirements, PhRMA organized a Web site in 1992'called Helping Patients'which provides data on all the access programs, contact information for the various companies offering free medications, and either electronic or printable enrollment forms, Grayson says. Companies researching new anti-HIV medications also typically provide the experimental treatments if patients run out of other treatment options, Grayson says. For example, Boehringer Ingelheim first made available the protease inhibitor tipranavir, which is in Phase III clinical trials, through an early access program in May 2003, expanding the program to include more patients in April 2004. Information on early access programs can be obtained through manufacturers.