Myalept (metreleptin subcutaneous injection – Chiesi) — Cigna

Initial criteria

• Patient meets ONE of the following (i or ii):
• i. Patient has congenital generalized lipodystrophy AND meets ONE of the following (a or b):
• a) Patient has had a genetic test demonstrating one gene mutation (AGPAT2, BSCL2, CAV1, or PTRF) confirming the diagnosis of congenital generalized lipodystrophy; OR
• b) Patient meets BOTH of the following (1 and 2): (1) Patient has had a genetic test that did not demonstrate an AGPAT2, BSCL2, CAV1, or PTRF gene mutation; AND (2) A clinical diagnosis of congenital generalized lipodystrophy has been made by a specialist with experience in treating patients with lipodystrophy; OR
• ii. Patient has acquired generalized lipodystrophy; AND
• Patient has experienced one or more manifestations of leptin deficiency (e.g., hyperinsulinemia, type 2 diabetes mellitus, hypertriglyceridemia); AND
• Myalept will be used in conjunction with dietary modification; AND
• Medication is prescribed by, or in consultation with, an endocrinologist or a geneticist.

Approval duration

1 year