Metreleptin (Myalept) (CPB 0882, reviewed 2026-07-10)

Immediately: (1) Billing and authorization teams must establish precertification requirement for ALL Metreleptin (Myalept) prescriptions through Aetna. (2) Update billing system to route Metreleptin claims to require prior authorization before processing. (3) Create pre-authorization checklist requiring: confirmed diagnosis of congenital or acquired generalized lipodystrophy (ICD-10 E88.12), lab documentation of leptin deficiency (<12 ng/mL), evidence of metabolic complication (diabetes E08-E13, hypertriglyceridemia E78.1, or hyperinsulinemia E16.1), and documentation of concurrent dietary modifications and exercise plan. (4) Train providers and staff that Metreleptin prescriptions require endocrinologist or lipodystrophy specialist involvement. (5) Before submitting claims: verify patient does NOT have HIV-related lipodystrophy, partial lipodystrophy (E88.11), liver disease, or obesity without lipodystrophy (E66.01-E66.9) — these are automatic exclusions and will be denied. (6) Submit precertification requests to Aetna at (866) 752-7021 or fax (888) 267-3277 using Statement of Medical Necessity (SMN) form available through Specialty Pharmacy Precertification. (7) For continuation of therapy, document improvement from baseline in metabolic control (improved glucose, decreased triglycerides, or decreased hepatic enzymes). Consequence: Claims submitted without completed precertification or missing required clinical documentation will be denied; patients with excluded diagnoses will have claims rejected.