PR Newswire; Thursday July 2, 9:01 am EST

Current Medicaid eligibility rules extend health care coverage to HIV-infected patients only after they have suffered an AIDS defining illness or after their CD4 count has declined to below 200. Patients living with the HIV virus but without the symptoms of full-blown AIDS are ineligible and, if unable to gain access to AIDS drugs through other means, must delay treatment until they experience the symptoms of AIDS. Although federally funded state- administered AIDS Drug

Assistance Programs (ADAPs) generally cover the drug costs for patients ineligible for Medicaid, many state programs have experienced financial shortfalls due to rapidly increasing enrollments and per patient costs and, as a result, have responded by restricting access to their programs.

AIDS activists attending the conference characterized the pharmacoeconomic study as a solid first step in the development of a critical policy basis for the expansion of life-saving AIDS drug therapies to the uninsured and underinsured. The research, which was conducted by a consortium of academic researchers, professional pharmacoeconomists, AIDS organizations and research- based pharmaceutical interests called the Treatment Access Expansion Project (TAEP), uses established pharmacoeconomic simulation techniques and data from existing clinical trials (Roche clinical trials NV15182 and NV15355) to draw two conclusions:

early initiation of treatment with AIDS drug cocktails delays the progression of AIDS, and

providing early treatment (i.e., when the patient has a CD4 count between 200 and 500 and has never experienced an AIDS defining event) would result in prolonged survival and would be cost-effective, when compared to delayed treatment (when the patient has a CD4 count of less than 200 or has experienced an AIDS defining event).

"At the most basic level, our research shows that patients receiving early, aggressive treatment experience increased lifespan," said Gary Rose, T.II.C.A.N.N. (Ryan White CARE Act Title II Community AIDS National Network) public policy director and community liaison with the Treatment Access Expansion Project and a chief researcher on the project. "Moreover, the overall cost of providing patients with this survival benefit is negligible."

In April 1997, Vice President Al Gore directed federal health officials to determine the feasibility of expanding Medicaid coverage to make new AIDS drugs available to the uninsured for early HIV treatment. In December, the Clinton Administration announced that an expansion in Medicaid along these lines would be too costly. "Ability to pay should not have to be a barrier to early intervention for people with HIV," said Daniel Zingale, Executive Director of the AIDS Action Council.

The new pharmacoeconomic study shows that early HIV treatment would increase life expectancy of currently infected asymptomatic patients (patients with a CD4 count between 200-500 and never having experienced an AIDS defining event) by 0.43 years (unadjusted for quality of life). The researchers determined that these gains in life expectancy would result in longer treatment with protease inhibitors and an expected increase in lifetime costs per patient of 2.2%. Ultimately, however, early AIDS treatment is projected to delay progression of AIDS-defining events and prolong survival, at a cost well within the range of generally accepted cost-effective medical interventions.

"This pharmacoeconomic study provides an important addition to any discussion on early treatment," said Dr. John Hornberger, Director of Health Economics in Roche Global Pharmacoeconomic Research. "By delaying the onset of the symptoms of AIDS, early treatment only slightly increases medical-care costs over the first 5 years by $241 per patient per year."

The principal sponsor of the TAEP pharmacoeconomic study is Hoffmann-La Roche. Roche Laboratories, a subsidiary of Hoffmann-La Roche, markets more than 35 medications in major therapeutic areas including AIDS, oncology, transplantation, infectious diseases, cardiovascular diseases and dermatology. Treatment Access Expansion Project: TAEP was initiated to develop and disseminate sophisticated pharmacoeconomic models for use by federal, state and local governments and other entities concerned with the budget implications of providing treatment to people living with HIV/AIDS. TAEP consists of a consortium of academic researchers, professional pharmacoeconomists, AIDS organizations and research-based pharmaceutical interests.

T.II.C.A.N.N.: The Ryan White CARE Act Title II Community AIDS National Network (T.II.C.A.N.N.) is a non-profit organization dedicated to initiating and supporting activities that ensure access to care for all Americans living with or affected by HIV.

Roche Laboratories Inc.: Roche Laboratories Inc. is the marketing and sales subsidiary of Hoffmann-La Roche Inc., a leading research-intensive pharmaceutical company. Roche Laboratories markets more than 35 medications in major therapeutic areas including AIDS, oncology, transplantation, infectious diseases, cardiovascular diseases and dermatology.

SOURCE: Treatment Access Expansion Project

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