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MyaleptCareFirst (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