I want to thank Dr Doug Mest for writing this letter and  Dr Bob Munk and Dr Daniel Berger for editing.  Please feel free to use this letter in your dealings with insurance companies. I will also post it in ww.facialwasting.org for download. Forward this email to doctors who may need it!

More details on the Sculptra program after Sept 23rd...

 

Insurance Co Name

Insurance Co Address

Patient Name

Subscriber #

 

Date

 

To Whom It May Concern:

 

This letter is written in regards to the medical necessity of restorative treatment for the facial deformities this patient suffers from secondary to HIV-Associated Lipoatrophy. Facial fat loss is the most devastating aspect of this condition as it can not be disguised by clothing or other means. Although the exact underlying mechanism of HIV-Associated Lipoatrophy is unknown (1), the devastating effects of this condition are known (2,3). Patients suffering from this condition are at an increased risk of depression, socially withdrawn and potentially suicidal. Furthermore, patients have even stopped their life saving HAART therapy without consultation with their physician in an attempt to stop this side effect. The implications for viral mutations, increasing viral load and worsening of patients underlying condition requiring more expensive treatments cannot be stressed enough. Treatment of HIV-Associated Lipoatrophy with Sculptraâ„¢(Poly-L-Lactic Acid) has been shown to improve anxiety and depression scores (4) as well as improve patient’s quality of life as measured by visual analogue scale (5).  The use of Sculptra is clearly indicated as a reconstructive procedure; that is, repair of abnormal facial structure caused by HIV or its treatment, in order to create a normal appearance.

 

The safety and efficacy of Sculptraâ„¢ in restoring the normal facial contours of patients suffering from HIV-Associated Facial Lipoatrophy has been evaluated by the US FDA (6). Based on the available scientific evidence (4,5), the FDA granted approval of Sculptraâ„¢ as a restorative medical device for the specific indication of HIV-Associated Facial Lipoatrophy in August 2004.

 

For your information. the ICD9 diagnosis code for lipodystrophy is 272.6. HIV-related lipodystrophy syndrome  consists of lipohypertrophy (fat accumulation in the visceral area and dorsocervical pad) and lipoatrophy (subcutaneous fat loss in the face, extremities and buttocks).

 

Due to the medical necessity of this treatment and the availability of a safe and effective treatment option, pre-approval is hereby requested for treatment of this patient’s HIV-Associated Facial Lipoatrophy with Sculptra™.

 

As this approval is relatively recent,  I would be happy to further educate your company on this issue in any way that you might deem helpful. Please feel free to contact me at the above office with any questions you may have.

 

 

Sincerely,

 

 

 

 

 

1)      Montessori, V. CMAJ. 2004;170:229-238.

2)      James J, Carruthers, A. Dermatol Surg. 2002;28:979-986.

3)      Martinez, E. Drug Saf. 2001;24:157-166.

4)      Moyle, GJ. HIV Medicine. 2004;5:82-87.

5)      Valantin, M. AIDS. 2003;17:2471-2477.

6)      FDA Scientific Advisory Panel 3/25/2004 Washington DC