Pa Notification Myalept
UnitedHealthcare prior authorization/notification program for Myalept (metreleptin) specifying initial and reauthorization clinical criteria, REMS requirement note, authorization duration, and additional clinical rules including potential automated approvals and supply limits.
Annual review 5/2025: Annual review with no changes to coverage criteria; updated background and reference.
Coverage Summary
Coverage stance: covered_with_criteria. Authorization duration: 12 months for both initial authorization and reauthorization. REMS requirement: REMS required — Myalept is available only through the Myalept REMS restricted program due to risks of anti-metreleptin (neutralizing) antibodies and lymphoma. Excluded indications: partial lipodystrophy, liver disease including NASH, HIV-related lipodystrophy, and metabolic disease without generalized lipodystrophy.
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