Subject: Myalept 1674-A SGM P2023

Drug

MYALEPT  (metreleptin)

Policy:

      I.   INDICATIONS

           The indications below including FDA-approved indications and
           compendial uses are considered a covered benefit provided that
           all the approval criteria are met and the member has no
           exclusions to the prescribed therapy.

          A.  FDA-Approved Indication
               Myalept is indicated as an adjunct to diet as replacement
               therapy to treat the complications of leptin deficiency in
               patients with congenital or acquired generalized
               lipodystrophy.

               Limitations of Use:
               1.  The safety and effectiveness of Myalept for the treatment
                    of complications of partial lipodystrophy have not been
                    established.
               2.  The safety and effectiveness of Myalept for the treatment
                    of liver disease, including nonalcoholic steatohepatitis
                    (NASH), have not been established.
               3.  Myalept is not indicated for use in patients with HIV-
                    related lipodystrophy.
               4.  Myalept is not indicated for use in patients with metabolic
                    disease, including diabetes mellitus and
                    hypertriglyceridemia, without concurrent evidence of
                    congenital or acquired generalized lipodystrophy.

          B.  Compendial Use
               Partial lipodystrophy in patients with confirmed leptin
               deficiency and metabolic abnormalities

          All other indications are considered experimental/investigational
          and not medically necessary.


    II.  DOCUMENTATION

          Submission of the following information is necessary to initiate
          the prior authorization review: leptin level (for initial requests)


  III.  EXCLUSIONS

          Coverage will not be provided for members with any of the
          following exclusions:
          A.  HIV-related lipodystrophy
          B.  Generalized obesity not associated with generalized
               lipodystrophy


   IV.  CRITERIA FOR INITIAL APPROVAL

          Lipodystrophy
          Authorization of 6 months may be granted for treatment of
          lipodystrophy when ALL of the following criteria are met:
          A.  Member has a diagnosis of congenital generalized
               lipodystrophy (i.e., Berardinelli-Seip syndrome), acquired
               generalized lipodystrophy (i.e., Lawrence syndrome), or
               partial lipodystrophy
          B.  Member has leptin deficiency confirmed by laboratory testing
               (i.e., less than 12 ng/ml)
          C.  Member has at least one complication of lipodystrophy (e.g.,
               diabetes mellitus, hypertriglyceridemia, increased fasting
               insulin level)


    V.  CONTINUATION OF THERAPY

          Lipodystrophy
          Authorization of 12 months may be granted to members
          requesting continuation of treatment for lipodystrophy when the
          member has experienced an improvement from baseline in
          metabolic control (e.g., improved glycemic control, decrease in
          triglycerides, decrease in hepatic enzyme levels)

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Myalept [package insert]. Dublin, Ireland: Amryt Pharmaceuticals DAC; February 2022.
2. Brown RJ, Araujo-Vilar D, Cheung PT, et al. The diagnosis and management of lipodystrophy syndromes: A multi-society practice guideline. J Clin Endocrinol Metab. 2016;101(12):4500-4511. doi:10.1210/jc.2016-2466
3. Handelsman Y, Oral AE, Bloomgarden ZT, et al. The clinical approach to the detection of lipodystrophy – an AACE consensus statement. Endocr Pract. 2013;19(1):107-116. doi:10.4158/endp.19.1.v767575m65p5mr06
4. Chan JL, Lutz K, Cochran E, et al. Clinical effects of long-term metreleptin treatment in patients with lipodystrophy. Endocr Pract. 2011;17(6):922-932. doi:10.4158/EP11229.OR
5. Garg A. Clinical review#: Lipodystrophies: genetic and acquired body fat disorders. J Clin Endocrinol Metab. 2011;96(11):3313-3325. doi:10.1210/jc.2011-1159
6. Rodriguez AJ, Mastronardi CA, Paz-Filho GJ. New advances in the treatment of generalized lipodystrophy: role of metreleptin. Ther Clin Risk Manag. 2015;11:1391-1400. doi:10.2147/TCRM.S66521
7. Lee HL, Waldman MA, Auh S, et al. Effects of metreleptin on proteinuria in patients with lipodystrophy. [published online ahead of print, 2019 Apr 16]. J Clin Endocrinol Metab. 2019;104(9):4169-4177. doi:10.1210/jc.2019-00200
8. Oral EA, Gorden P, Cochran E, et al. Long-term effectiveness and safety of metreleptin in the treatment of patients with partial lipodystrophy. Endocrine. 2019;64(3):500-511. doi:10.1007/s12020-019-01862-8

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