Pharmacy Prior Authorization Criteria

Myalept (metreleptin for injection)

Indications for Prior Authorization

Myalept (metreleptin for injection)

• For diagnosis of Congenital or acquired generalized lipodystrophy
  Indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy

Criteria

Myalept

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of congenital or acquired generalized lipodystrophy
AND
• Patient is refractory to current standards of care for lipid and diabetic management
AND
• Prescribed by or in consultation with an endocrinologist
AND
• Documentation demonstrates that patient has at least one of the following metabolic abnormalities: [2]
• Insulin resistance (defined as requiring more than 200 units per day)
• Hypertriglyceridemia
• Diabetes mellitus

Myalept

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy, such as one of the following:
• Sustained reduction in hemoglobin A1c level from baseline
• Sustained reduction in triglyceride levels from baseline

P & T Revisions

2024-06-24, 2023-10-10, 2023-07-20, 2022-07-13, 2021-07-01, 2021-05-21, 2020-08-19, 2019-07-09

References

1. Myalept Prescribing Information. Amryt Pharmaceuticals DAC. Dublin, Ireland. March 2023.
2. Handelsman Y, Oral EA, Bloomgarden ZT, et al. The clinical approach to the detection of lipodystrophy – an AACE consensus statement. Endocrine Practice 2013;19(1):107-116.
3. Araujo-Vilar, D., Santini, F. Diagnosis and Treatment of Lipodystrophy: A Step-by-Step Approach. Journal of Endocrinological Investigation volume 42, pages61–73 (2019). Available at https://link.springer.com/article/10.1007/s40618-018-0887-z. Accessed July 13, 2022.
4. UptoDate: Lipodystrophic syndromes. available at: https://www.uptodate.com/contents/lipodystrophic-syndromes?search=lipodustrophy&source=search_result&selectedTitle=1%7E61&usage_type=default&display_rank=1#H28. Accessed June 24, 2024.

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Revision History

• 2024-06-24: 2024 Annual Review.
• 2023-10-10: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-07-20: 2023 Annual Review
• 2022-07-13: 2022 Annual Review
• 2021-07-01: 2021 Annual Review
• 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
• 2020-08-19: Annual review - removed drug name in reauthorization criteria for consistency. Updated references.
• 2019-07-09: Annual review. No changes to clinical criteria. Updated references. XC 7/9/19.

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