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NewFill is approved, now what?
Mar 27, 2004

Dear Nelson:

I heard today that NewFill was approved in the US by the FDA. Does this mean insurance will pay for it? Will the company help patients with no money or insurance? You seem to be the one who knows the most about facial wasting in this site, so please help us out! Thanks for your great work as a consumer.

Eduardo

Response from Mr. Vergel

Dear Eduardo:

Thanks for the very timely question. The name for NewFill in the US will be Sculptra and it will be marketed by Dermik Laboratories. The FDA has not approved it yet for HIV related facial lipoatrophy but their panel of experts recommended approval this past Thursday, March 25th (I attended the hearing and gave a testimony as the founder of facialwasting.org.) So we are all waiting to hear from the FDA.

Once it gets approved, I am anxious to see what the battle will be to get this product reimbursed by insurance and Medicaid (Medicare can pay for doctor's labor). This will require for all patients with HIV lipoatrophy in the US to persevere and stress the fact that this is not a cosmetic procedure but a reconstructive one. As you know, facial wasting is caused to HIV infection and the use of nucleoside analogs like Zerit and AZT, so most of us will be requiring correction to an illness/drug related physical change that affects self-image, self esteem, and medication adherence.

Dermik is trying to set up a patient assistance program to provide free product to those with no insurance. But I am still concerned about what doctors will charge these patients for their labor. Also, physician training will be essential. I would not be surprised if the FDA followed the panel's recommendation to require Dermik to set up training for all doctors who want to purchase the product. Another concern is the off label use of this product for wrinkles and how product intented for use in HIV patients under the free access program can end up being used in non HIV patients for cosmetic purposes (this is a much bigger market than HIV lipoatrophy!.)

As you can see, the next few weeks will be very interesting ones in this development. Please keep reading my column here at thebody.com since I will try to give updates on this issue every two weeks.

I am glad we are getting closer at having an approved solution to facial wasting in the US. There will be two more products that will follow Sculptra in the future (Silskin and Bio-Alcamid), so it is important to set a good precedent now.

Nelson



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