Myalept — Medical Mutual

Initial criteria

• Patient has congenital generalized lipodystrophy with EITHER genetic test demonstrating AGPAT2, BSCL2, CAV1, or PTRF mutation OR genetic test negative for these mutations AND clinical diagnosis made by a specialist with experience in lipodystrophy OR patient has acquired generalized lipodystrophy
• Patient has experienced one or more manifestations of leptin deficiency (e.g., hyperinsulinemia, type 2 diabetes mellitus, hypertriglyceridemia)
• Myalept will be used in conjunction with dietary modification
• Conventional therapy for metabolic disturbances has failed (e.g., diet and lifestyle modification, statins, anti-diabetic agents)
• Medication is prescribed by or in consultation with an endocrinologist or a geneticist

Reauthorization criteria

• Patient continues to meet initial criteria
• Patient’s condition has improved or stabilized while using Myalept (e.g., sustained improvement in triglyceride levels, hemoglobin A1c from baseline, or provider confirmation that Myalept is still working)

Approval duration

1 year initial, 1 year reauth