Myalept (metreleptin) Prior Authorization Policy
Prior authorization guidance for pharmacy benefit coverage of Myalept (metreleptin) for treatment of complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy, including initial and continuation criteria, duration of approvals, conditions not recommended for approval, and documentation requirements.
No material clinical/coverage changes identified on this review (has_material_change=false).
Coverage Summary
Myalept (metreleptin) coverage stance: covered with criteria for the FDA‑approved indication of generalized lipodystrophy (congenital or acquired). Scope: prior authorization guidance for pharmacy benefit coverage including initial and continuation criteria, 1‑year initial and 1‑year extended approval durations, requirements for specialist prescribing, and documentation requirements. Safety/REMS: Myalept carries boxed warnings for risk of lymphoma and for development of neutralizing anti‑metreleptin antibodies; it is available only through a REMS program that requires practitioner training and use of a REMS Prescription Authorization Form.
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