Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date. |
AIDS TREATMENT NEWS - December 31, 2004
John S. James
Summary: Dermik Laboratories is now starting a patient-assistance program that provides free or low-cost drug to patients that meet certain imcome and other eligibility requirements. Information is changing rapidly, so we provide Web, email, and telephone sources to check.
Sculptra™ (marketed in some countries as New Fill™) was approved in August 2004 by the FDA "for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus." It was approved narrowly for this use because of the great need of many patients -- but the FDA wants to see more data before allowing its wider use for cosmetic purposes, where the need is not as great.
The product is expensive in the U.S. (about three times the price in Europe) -- in addition to the cost of doctors' services, which can vary greatly. It is important to find a physician who is well trained or experienced in its use.
Dermik Laboratories (owned by Sanofi-Aventis), the company now selling Sculptra in the U.S., is setting up a patient-assistance program that will provide free or reduced-cost drug to patients who meet certain income and other eligibility requirements. It does not pay the doctors' bill, however. The key issue will be to get Sculptra covered by regular health insurance, like other reconstructive medicine. Some companies are refusing to pay for it by claiming it is "cosmetic." But many patients cannot maintain their job or career without the treatment.
Information about Sculptra -- choosing a doctor, getting coverage through one's health insurance, or getting patient assistance if insurance is not available -- is changing rapidly:
Currently (December 2004) the best information is available through an email list run by well-known activist Nelson Vergel. You can read an archive of the messages even without subscribing, at http://health.groups.yahoo.com/group/pozhealth/ Also, you can subscribe by sending a blank email to PozHealth-subscribe@yahoogroups.com -- and then following the instructions you will receive from Yahoo to confirm that you want the subscription. If you subscribe you may want to use the Digest option (to get no more than one email per day), as currently there are about 30 new messages a week on Sculptra alone. Note the medical necessity letter to help doctors in requesting reimbursement, at http://health.groups.yahoo.com/group/PozHealth/message/8047.
The official number for both doctors and patients to call for the Sculptra Access Program is 1-888-SCULPTRA (888-728-5787). Also see the official Web site, http://www.sculptra.com/. Note the patient information sheet, but also the physician information at http://www.sculptra.com/US/resources/SculptraPI.pdf
You could also use a Google search, such as "Sculptra patient assistance" (without the quotes), or "Sculptra 2005" (also without the quotes) to locate recent articles.
A background article by Bob Roehr in the Dallas Voice, published December 2004 or earlier, is at http://www.dallasvoice.com/articles/dispArticle.cfm?Article_ID=4418
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