Tighter Controls Set for AIDS Drug

To curb abuses that include a black market among bodybuilders, California officials said Thursday that they are tightening controls on an expensive AIDS drug that has cost the state’s health program for the poor more than $175 million in the past four years.

Beginning June 1, Medi-Cal will require that new prescriptions for the anti-wasting drug Serostim, which costs up to $7,000 a month, be state-approved before they can be filled. Initial prescriptions will be limited to four weeks.

Officials said the move will save at least $7.5 million a year from the state’s rapidly growing $3-billion drug tab and will bring one of its most costly drugs under control.

Restrictions on Serostim, a human growth hormone that helps build muscle mass, have been so relaxed that last year Medi-Cal spent more on it than did New York, Florida and Texas combined.

Currently, California allows patients to receive up to three months’ worth of Serostim with only a doctor’s prescription and no state approval.

The Times reported in February that the state Department of Health Services maintained a looser grip on the drug than other large states do and that Medi-Cal rules were less stringent than those of another agency in the same department. The state’s smaller AIDS Drug Assistance Program -- for people who do not qualify for Medi-Cal -- already requires prior approval.

“Certainly the article got our attention,” said Stan Rosenstein, state deputy health director for medical care services. He said the decision, announced Thursday, was prompted by concerns about fraud associated with the drug, as well as by budgetary considerations and a desire to make state regulations consistent.

The high cost and bodybuilding capabilities of Serostim generated abuses in California that officials estimate have cheated taxpayer-funded Medi-Cal of tens of millions of dollars.

Part of the supply was diverted to the underground drug trade. Doctors without AIDS expertise gave prescriptions to patients who did not need them. And some patients sold their medicine, officials said.

Members of one statewide ring have been prosecuted for selling more than $3.5 million in Serostim -- paid for by taxpayers --at gyms and spas. Other investigations into Serostim fraud are ongoing.

State officials gradually began adding controls a couple of years ago, but until now, they resisted a prior-authorization requirement, fearing it would restrict patient access to the drug.

Michael Weinstein, executive director of the AIDS Health Care Foundation, praised the Davis administration for responding to pleas from his organization and others to clamp down on Serostim abuse in a time of threatened health-care cuts.

“I would guess [the new controls] would reduce usage by like 80%,” said Weinstein. “I would think the spending would be no greater than $6 million to $7 million a year.”

Last year, Medi-Cal spent $33.2 million on Serostim, down from a peak of $53.5 million in 2000, officials said.

David Pieribone, the associate director for education at AIDS Project LA and a participant in early clinical trials for Serostim, said the tighter controls were necessary because of the abuse by bodybuilders and others who had no medical need for the drug.

But Pieribone urged the state to closely monitor whether the constraints are preventing deserving patients from getting it.

“If it’s saving money, great,” he said. “But maybe they’re saving money at the expense of patient lives or disease progression. That is important too.”

In the coming weeks, doctors and pharmacists will be informed about the new Serostim restrictions. Patients who already have prescriptions will be required to go through the prior-approval process when they renew them.

Carolyn Castel, spokeswoman for Serostim’s maker, Serono Inc., declined to comment, saying that it was not aware of the state’s intentions.

State officials also said Thursday that they will impose the same requirements on Oxandrolone, a steroid used to prevent wasting in AIDS patients. They said they fear that bodybuilders and others who are abusing Serostim may try to switch to Oxandrolone.

In a separate effort to hold down spending, officials also imposed prior-approval requirements on a new antiviral AIDS drug called Fuzeon, which costs more than $20,000 per year per patient.

Serostim is the first drug approved by the federal government to counter AIDS wasting, which causes the body to consume muscle and organ tissue. There is debate about its cost and effectiveness, and federal and state authorities are investigating the marketing practices of Serono. The company has denied any wrongdoing.