Subject: Specialty Quantity Limit Myalept 2892-H P2023

Drug

MYALEPT  (metreleptin)

Policy:

      I.  PROGRAM DESCRIPTION

          The standard limit is designed to allow a quantity sufficient for
          the most common uses of the medication. The recommended
          dosing parameters for all FDA-approved indications fall within
          the standard limits. Coverage of an additional quantity may be
          reviewed on a case-by-case basis upon request.

   II.  COVERED QUANTITIES

Medication	Standard Limit	FDA-recommended dosing
Myalept   (metreleptin)   11.3 mg/vial	30 vials per 30 days	•    Body weight 40 kg or less: starting        dose 0.06 mg/kg/day, up to maximum        daily dose of 0.13 mg/kg.   •   Males > 40 kg body weight: starting        dose 2.5 mg/day, up to a maximum        dose of 10 mg/day.   •   Females > 40 kg body weight: starting       dose 5 mg/day, up to a maximum dose       of 10 mg/day.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Myalept [package insert]. Dublin, Ireland: Amryt Pharmaceuticals DAC; February 2022.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

August 13, 2023