HCFA reverses ruling on AIDS wasting treatment

Wasting drugs used for more than just cosmetics

Until this spring, AIDS patients in Texas could not receive Medicaid funding for a drug called Serostim that has been shown to reverse some health problems caused by AIDS wasting. Texas officials denied Medicaid coverage based on a federal government definition of the drug, which says it is used for cosmetic weight gain.

AIDS advocacy groups protested both the definition and Texas’ decision, and after a year and a half, they’ve convinced the Baltimore-based Health Care Financing Administration (HCFA) to reverse the decision.

"What’s so important about this is we want to ensure that every person in the country has equal access to the drugs they need to help keep them alive," says Cornelius Baker, executive director of the National Association of People with AIDS in Washington, DC.

Serostim, manufactured by Serono Laboratories in Norwell, MA, is a protein-sparing and protein-building agent that causes a significant increase in lean body mass and weight, along with a decrease in body fat. A human growth hormone, Serostim is administered via small needle injections just under the skin daily at bedtime. Clinical trials showed that 76% of AIDS wasting patients given Serostim gained weight, and 70% gained significant lean body mass.

Because AIDS wasting causes patients to gain fat mass and lose muscle mass, which could lead to a host of health problems, Serostim’s potential to reverse this trend offers much-needed help. However, the drug costs $36,000 per patient per year, according to a cost-containment program Serono implemented in 1996.

Texas, which has about 20,000 HIV-infected people, denied Medicaid coverage of Serostim because the state doesn’t cover cosmetic treatment, a decision that left AIDS patients on Medicaid without access to the drug. Texas officials had asked HCFA to determine whether Medicaid programs could deny reimbursement for Serostim based on its use as a weight-gain drug. HCFA initially said the state could assume Serostim was solely used for weight gain.

"Clearly this is a case where one state, Texas, had chosen to not cover this as a drug, and that wasn’t fair to people with HIV living in Texas," Baker adds. "We’re glad we have proven that human growth hormones like Serostim are not just cosmetic, but have medical benefits."

Earlier this year, HCFA reversed its decision, acknowledging that Serostim is used to fight the life-threatening condition of AIDS wasting. AIDS wasting or cachexia is a major contributing factor to the high death rate among AIDS patients because it’s a destructive metabolic process that uses the patient’s own muscles and organs to supply the body with energy.

HCFA’s decision followed a letter to HCFA from the Food and Drug Administration (FDA) in Rockville, MD, in which the FDA stated, "Serostim is approved for the treatment of AIDS wasting or cachexia, which is associated with increased morbidity and mortality."

With Medicaid providing health care coverage to about 60% of adults with AIDS and 90% of children with AIDS, the recent HCFA reversal is crucial, Baker says.

The National Association of People with AIDS will continue to work with federal funding vehicles, such as the AIDS drug assistance programs, to make sure Serostim is covered for patients who do not receive Medicaid coverage, Baker adds.