Egrifta WR (tesamorelin for injection) — Highmark
Reduction of excess abdominal fat in HIV‑infected adult patients with lipodystrophy
Initial criteria
- age ≥ 18 years AND age ≤ 65 years
- Diagnosis of human immunodeficiency virus (HIV) infection (ICD‑10: B20)
- Receiving antiretroviral therapy for ≥ 8 weeks AND continues antiretroviral therapy
- Diagnosis of abdominal lipodystrophy (ICD‑10: E88.1)
- If male: waist circumference ≥ 95 cm AND waist‑to‑hip ratio ≥ 0.94
- If female: waist circumference ≥ 94 cm AND waist‑to‑hip ratio ≥ 0.88
- Fasting blood glucose < 150 mg/dL
Reauthorization criteria
- Continues to receive antiretroviral therapy for HIV infection
- Has experienced a reduction in visceral adipose tissue (for example, reduction in minimum waist circumference, waist‑to‑hip ratio, or reduction in BMI from baseline)
Approval duration
Initial: up to 6 months; Reauthorization: up to 12 months