Myalept — CareFirst (Caremark)
Partial lipodystrophy in patients with confirmed leptin deficiency and metabolic abnormalities
Initial criteria
- Member has a diagnosis of congenital generalized lipodystrophy (Berardinelli-Seip syndrome), acquired generalized lipodystrophy (Lawrence syndrome), or partial lipodystrophy
- Member has leptin deficiency confirmed by laboratory testing (less than 12 ng/ml)
- Member has at least one complication of lipodystrophy (e.g., diabetes mellitus, hypertriglyceridemia, increased fasting insulin level)
- Member does not have HIV-related lipodystrophy
- Member does not have generalized obesity not associated with generalized lipodystrophy
Reauthorization criteria
- Member has experienced an improvement from baseline in metabolic control (e.g., improved glycemic control, decrease in triglycerides, or decrease in hepatic enzyme levels)
Approval duration
Initial: 6 months; Reauthorization: 12 months