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AetnaAll Plans · Prior Auth · Medical Policy · EndocrinologyMedium impact

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

Effective date
Not stated in the notice
Identified
Aug 16, 2026

Summary

Aetna requires precertification for metreleptin (Myalept) for all participating providers and members in applicable plan designs. Aetna considers metreleptin medically necessary for congenital or acquired generalized lipodystrophy when the initial approval criteria are met, and considers it experimental, investigational, or unproven for partial lipodystrophy, HIV-related lipodystrophy, generalized obesity not associated with generalized lipodystrophy, and liver disease including metabolic dysfunction associated steatohepatitis (MASH). Continuation of therapy is medically necessary when the member has improved from baseline in metabolic control and continues dietary modifications along with regular exercise.

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What to do

Action · 6 steps
01Before scheduling metreleptin, get precertification by calling (866) 752-7021 or faxing (888) 267-3277.
02For Statement of Medical Necessity precertification forms, use the Specialty Pharmacy Precertification forms.
03Billing team: confirm the prescriber is an endocrinologist or a provider specialized in treating congenital or acquired generalized lipodystrophy, or prescribes in consultation with one.
04Keep documentation of a diagnosis of congenital generalized lipodystrophy (Berardinelli-Seip syndrome) or acquired generalized lipodystrophy (Lawrence syndrome), leptin deficiency confirmed by laboratory testing (less than 12 ng/mL), at least one complication of lipodystrophy such as diabetes mellitus, hypertriglyceridemia or increased fasting insulin, and the member's use of dietary modifications with regular exercise.
05For continuation, keep documentation of improvement from baseline in metabolic control, such as glycemic control, triglycerides or hepatic enzyme levels.
06Providers prescribing Myalept must be certified with the Myalept REMS Program by enrolling in and completing its training.

Codes mentioned

96372E16.1E78.1E88.12E88.11B20G93.49

Original notice

Metreleptin (Myalept) (CPB 0882, reviewed 2026-07-10)
aetna.com · Always check the source before changing claims.
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