Sep 24, 2004  |  By: PHIL LaPADULA  | COMMENTS     

FORT LAUDERDALE, Fla. — After taking HIV drugs for years, John was showing the classic signs of AIDS atrophy — sunken cheeks caused by loss of fatty tissues in the face.

“It made me look older, and it was making me depressed,” said “John,” a patient of Apex South Beach clinic in Miami Beach, who did not want his real name disclosed because of concerns about job security.

In March, John decided to participate in a clinical trial of Sculptra, a new treatment for HIV atrophy. After three treatments, John was looking and feeling more like his old self again.

“People started complimenting me and telling me how good I looked,” John said. “It made me feel better about myself.” His reconstructed cheeks “look very natural,” he said.

But John, who relies on Social Security and help from his family to pay his medical bills, will not be able to afford the follow-up Sculptra maintenance treatments, which are required every one to two years depending on the patient.

After the Food & Drug Administration approved Sculptra in August, the manufacturer, Dermik Laboratories, in Berwyn, Pa., priced the treatment nearly four times higher than the price in Europe, where the treatment has been used since 1999.

Sculptra sells for $125 per bottle in Europe and South America, according to Dr. Peter Engelhard, director of Apex South Beach clinic, which specializes in the treatment of HIV atrophy.

Engelhard, who previously purchased the treatment from the French company that originally created it, now must pay $480 per bottle, the price the manufacturer has set for the U.S.

Each treatment requires two to three bottles of Sculptra, and each patient needs three to six treatments, depending on the severity of their condition, Engelhard said. After the initial treatment phase, a maintenance treatment that requires one to two bottles is needed every one or two years.

Price discouraging patients?
Karen Boyce, manager of communications for Dermik Laboratories, said the company had received “several inquiries about the cost of the drug and access to the drug.”

Boyce said the company is developing a “patient access” program for Sculptra, to help make it available to people who cannot afford the drug. But she declined to discuss details of the program because it has not been finalized. She said details about the access program would be available in late October.

Boyce pointed out that Sculptra is sold to doctors, not patients, and suggested doctors could set lower prices for patients with hardships.

But Engelhard, who was planning to meet with Dermik officials this week, doesn’t think the access program will be sufficient to meet patient needs.

“I don’t think it will offer enough of a discount,” he said.

Engelhard said he had 170 patients on a waiting list before the FDA approved the drug. But after the drug was approved and the price was hiked, all but about 30 percent of the patients on the list told him they couldn’t afford it.

“They’re either getting a different product or none at all,” Engelhard said. “It’s too bad because this is the best one.”

Engelhard thinks the treatment’s U.S. price will severely limit its use in the people who need it.

Reconstruction vs. cosmetics
Engelhard said insurance companies are not likely to cover Sculptra because they consider it a cosmetic treatment in the same class as Botox treatment for wrinkles. But he thinks treating atrophy is much more vital to the quality of life for HIV patients.

“Our argument is that this is reconstruction,” said Engelhard, likening the procedure to reconstructive surgery following breast cancer. “People do things like stop taking their medications because of atrophy, and that does change their longevity.”

But the treatment is not likely to be included in state drug assistance programs because it is not actually a drug, according to Jonathan Appelbaum, of Fenway Community Health, a Boston center that specializes in gay health.

Sculptra is considered a treatment, or device, not a drug, Appelbaum said.