PI Action alerts & updates ... 2004
What is Sculptra?
In August 2004, the FDA approved Sculptra (a poly-L lactic acid
formerly known as NewFill) for the restoration and/or correction
of the signs of facial fat loss due to HIV related lipoatrophy (i.e.
facial wasting). The company, Dermik Aesthetics, filed for approval
based on European studies in 278 people with severe facial wasting.
The majority of those studied were white men aged 41–45 years,
nearly all of who were on anti-HIV therapy. People received three
to six rounds of Sculptra treatment, consisting of multiple small
injections, at two-week intervals. Volunteers were then monitored
for two years. Roughly 40% of people studied had a significant lasting
increase in the volume of tissue in their cheeks for up to two years
following the series of injections. Quality of life measures (i.e.
anxiety and depression surveys) also improved significantly. This
is key given facial wasting is linked with depression and a reduced
ability to adhere to anti-HIV regimens.
Sculptra causes scar tissue (i.e. collagen) to collect in the areas
where it is injected. The amount of Sculptra injected and the method
and placement of each injection can strongly impact the results.
Proper training is essential to achieve the best results. It can
cause very small lumps called micronodules to form in up to 44%
of people receiving it. The micronodules are not usually visible
or the source of ongoing inflammation and infection—as with
other types of injectable fillers—but they can often be felt
under the skin. Although most doctors use a numbing agent like lidocaine
when injecting Sculptra, there is usually mild to moderate pain
during the injections. Sculptra can also cause tenderness, swelling
and bruising at the site of injection. This typically goes away
within days.
The level of fullness resulting from each round of injections varies
from person to person. People with more extreme facial wasting will
sometimes require more than six rounds of injections to achieve
lasting results. There are little data on the long-term use of Sculptra,
or on its use in women and people with darker skin.
The FDA placed two conditions on Sculptra’s approval. First,
the company may not encourage its use for cosmetic purposes in people
not infected with HIV (e.g. to fill in wrinkles). The company also
agreed to conduct an open-label study of 100 volunteers for five
years to evaluate Sculptra’s long-term safety. The study will
include at least 30 females and 30 people with dark skin types.
How Much Does Sculptra Cost?
When Sculptra was owned, manufactured and distributed by its inventor,
Dr. Elisabeth Laglenne, it was typically available for sale in Europe
or Mexico for as little as $200 per kit (two vials). Just prior
to Sculptra’s FDA approval, the buyer’s club DAAIR in
New York sold it for $400 per kit. Post approval, Sculptra is now
selling for about $960 per kit. Thus, Sculptra now costs more than
twice as much as it did before approval. Activists have been told
that its price will be increased in Europe and elsewhere accordingly.
In these countries it will continue to be sold as New-Fill.
Most people need a minimum of four kits, and since providers can
change as much as $500 or more (per kit) to administer the injections,
a full round of treatments could easily cost in excess of $6,000.
Increasing Access to Sculptra
Community representatives, including Project Inform, met with representatives
of Dermik on September 23 in Philadelphia to begin hammering out
a Patient Assistance Program (PAP). Though the details of that program
will not be clear until the time of its launch, there are several
general concepts that we can share at this time:
- Dermik hopes to launch the PAP near the end of October 2004.
- The PAP will likely be handled through a third party administrator
chosen by Dermik.
- Community representatives urged Dermik to consider the significant
financial challenges for most people living with HIV who have
facial wasting. Many will find it difficult even to afford the
cost of the provider to administer the injections.
Project Inform and other community-based groups will be working
with decision makers to explore the issues related to reimbursement
for the product itself and the medical procedure. In our initial
discussions with medical providers and the California Department
of Managed Care, we have learned that reimbursement will likely
be determined by whether the insurer deems the procedure reconstructive
or cosmetic. There is precedent for coverage of reconstructive surgery
in other areas such as breast cancer. However there are neither
officially defined criteria nor clear precedent for reconstruction
in HIV related lipoatrophy. In addition, unlike a radical mastectomy,
lipoatrophy has varying levels of severity and it is likely that
the reconstructive versus cosmetic determination will have to be
made on a patient-by-patient basis.
Community representatives, including some from Project Inform,
will be working with medical providers and private and public insurance
decisions makers to determine and develop acceptable criteria for
those who need this procedure. However, given the current ADAP and
Medicaid budget battles, it is unlikely that public systems will
add Sculptra to their formularies in the near future. Private health
insurers are also tightening their belts and forcing more costs
onto consumers, so coverage in this arena will also be a challenge.
In the meantime, Project Inform will continue to work with networks
of trained providers to develop strategies to deal with reimbursement
issues for this therapy.
