Myalept (metreleptin) — Medica

Generalized lipodystrophy (congenital or acquired)

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 (i.e., 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.

1 year