Myalept (metreleptin) — Highmark

acquired generalized lipodystrophy (Lawrence syndrome)

Initial criteria

Diagnosis of congenital generalized lipodystrophy (Berardinelli-Seip syndrome) OR acquired generalized lipodystrophy (Lawrence syndrome) (ICD-10: E88.1)
AND male leptin level < 8 ng/mL OR female leptin level < 12 ng/mL
AND one of the following: diagnosis of diabetes mellitus (ICD-10: E08 - E13) defined as HbA1c ≥ 6.5% OR fasting blood glucose ≥ 126 mg/dL OR two-hour plasma glucose ≥ 200 mg/dL OR symptoms of hyperglycemia with random plasma glucose ≥ 200 mg/dL; OR fasting insulin > 30 μU/mL; OR fasting triglycerides > 200 mg/dL
AND therapeutic failure to one previous therapy for diabetes (e.g., metformin, insulin) OR hypertriglyceridemia (e.g., statin, fibrate)

Decreased HbA1c by at least 0.8% from baseline OR decreased fasting triglycerides by at least 25% from baseline OR decreased fasting plasma glucose by at least 25% from baseline

12 months