HCFA reverses Medicaid ruling on serostim

AIDS treatment now covered nationwide

The Health Care Financing Administration (HCFA) has ruled that the recombinant human growth hormone serostim (Serano Laboratories) must be covered by Medicaid for the treatment of cachexia, the metabolic wasting effect that strikes AIDS patients.

In 1997, the agency ruled in favor of a Texas Medicaid decision not to cover the drug when state officials argued that language in the Social Security Act disallowing coverage of drugs used for "cosmetic weight gain" applied to serostim and its usage for AIDS patients.

After the ruling, Texas and national HIV and AIDS support groups fought to reverse it by using the clinical data on the drug’s ability to fight the condition as evidence that serostim use was anything but cosmetic.

Cachexia causes tissue, organs, and muscles to deteriorate as they are drafted into the body’s fight for energy sources; the deterioration heightens the susceptibility of infection against an already weakened immune system. Following the HCFA interpretation, the U.S. Food and Drug Administration, which granted serostim orphan drug status in 1996, sent a letter to HCFA supporting the clinical necessity of the drug while commenting on the increased morbidity and mortality associated with the condition.

Upon changing its ruling, HCFA stated, "In light of further information provided by the FDA, we have decided to change our policy with respect to serostim."

The drug is the first biotechnology therapy approved for AIDS wasting effect.

"This is a major achievement," says Terje Anderson, executive director of the National Association of People with AIDS (NAPWA). "We are committed to making sure that every person with AIDS has access to life-saving drugs."

The organization says that serostim helps patients recover "lean body muscle mass" instead of simple fat. The drug is both an anabolic protein builder and an anticatabolic, or protein sparing, agent. That means muscle mass is used effectively in part because the drug causes the body to use fat appropriately as an energy source.

NAPWA also says many patients on successful protease inhibitor regimens do gain weight, but the weight gain comes primarily from fat. The organization says 15% to 20% of patients on a protease regimen who are gaining weight still should be monitored for levels of lean muscle mass. The Centers for Disease Control and Prevention defines cachexia as an involuntary weight loss at or greater than 10% of baseline weight.

[For additional information, contact the Health Care Financing Administration at (410) 966-3000, the National Association of People with AIDS at (202) 898-0414, or Serano Labs at (800) 283-8088.]