Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1: The patient is a 52-year-old male with HIV related lipodystrophy. He is requesting coverage for Serostim injections to alleviate symptoms and side effects relative to fat accumulation including respiratory distress, limited range of motion, and need to modify sitting/sleep position. Prior interventions including diet, exercise, metformin and testosterone provided no benefit. The Health Plan indicates Serostim injections are considered investigational for treatment of lipodystrophy. Given the well-documented morbidity associated with the patients abdominal lipodystrophy, a trial of therapy with Serostim is indicated. It does not appear there is an alternative intervention for this patient with a severe condition that continues to worsen despite multiple interventions. Though Serostim injections have not been approved by the Food and Drug Administration for this indication, the preliminary data supplied warrants its usage off-label in this otherwise untreatable circumstance. Therefore, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned. Physician 2: The patient is a 52-year-old HIV positive male. His provider has requested a trial of recombinant human growth hormone (Serostim injections) to treat severe lipohypertrophy (also referred to as visceral adipose tissue accumulation or lipodystrophy). The patient is described as having massive accumulation of intraabdominal fat, and fat in the lower chest, neck and face. This is substantiated in the included pictures of the patient. The fat has accumulated rapidly and is interfering with the patients work and activities of daily living, as well as his sleep. The Health Plan has denied coverage for Serostim injections on the basis the therapy is considered investigational in this clinical setting. Lipohypertrophy is a relatively newly recognized condition in patients with HIV and the cause is unknown. It is believed to be multifactorial with HIV infection, insulin resistance, and antiretroviral medications all playing some role. There is no FDA approved treatment for this condition. Liposuction is often ineffective and cannot be performed on intraabdominal fat and the fat often quickly reaccumulates anyway. While diet and exercise may help, they do not reverse the condition. Metformin and testosterone replacement may also play a role, but have not been proven effective. All of these measures have already been tried for this patient, and none have helped. The results of a placebo-controlled, double blinded trial of 245 HIV patients testing Serostim in abnormal visceral adipose tissue accumulation have been presented at meetings and published in a respected, peer reviewed journal (Kotler, et al.). The results show significant improvement in patients who received Serostim. There are also numerous pilot studies, which suggest Serostim may be the most effective treatment thus far. Furthermore, there are many reports of dramatic improvement in certain patients with lipohypertrophy while on Serostim. Given these findings and the patients lack of response to standard therapies, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned. Physician 3: The patient is a 52-year-old man with HIV related lipodystrophy. The patients provider has noted the patient has very severe lipodystrophy including massive fat accumulation in his abdomen, lower chest, neck and face. According to the patients provider the intraabdominal fat creates so much pressure on the patients diaphragm and thorax that the patient must sleep in a sitting position. Attempted treatments have included testosterone, changes in the HIV therapy used, metformin, dietary modification, and exercise. The patients provider has recommended Serostim injections for treatment of the patients lipodystrophy. The Health Plan indicates the efficacy of Serostim injections for treatment of the patients medical condition has not been established. HIV associated lipodystrophy is associated with therapy for HIV disease. It has been noted for the last five to six years and is usually seen in patients treated with HAART (high active antiretroviral therapy). In addition to the maldistribution of fat, changes occur in insulin handling and in serum lipid concentrations. Therapy for this condition has been only partially successful. Usual attempts at therapy include modifying the regimens of antiviral therapy, administering testosterone, giving metformin, and ordering diet and increased physical activity. In some patients, the fat maldistribution is not associated with significant health problems. In others, significant debility can occur. The patients provider notes that the visceral fat accumulation is severe enough to limit activity and to compromise breathing.Given that there are no FDA approved therapies for this visceral fat accumulation, it is usual practice to attempt treatment in a number of ways. This patient has already exhausted such therapies. While the data regarding the use of Serostim in treatment of this condition is limited, it is an appropriate next step. This approach is favorably evaluated in the papers cited above as well as the article by Kotler, et al. that was provided by the patient. Therefore, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.