CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Myalept (metreleptin) coverage for lipodystrophy

Defines prior authorization criteria, indications, limitations, exclusions, documentation requirements, and authorization durations for Myalept (metreleptin) to treat leptin deficiency associated with lipodystrophy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMyalept (metreleptin) coverage for lipodystrophy

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit leptin level for initial prior authorization and document diagnosis and required clinical information to meet criteria; initial approvals are 6 months and continuation approvals are 12 months when criteria are met.

POLICY UPDATE CHANGES

No material changes to clinical coverage or policy criteria.

6/12Auth durations (months) initial/continuation

<12Leptin deficiency threshold

Generalized/PartialCovered diagnostic categories

Coverage Summary

Coverage stance: covered_with_criteria. Scope summary: Defines prior authorization criteria, indications, limitations, exclusions, documentation requirements, and authorization durations for Myalept (metreleptin) to treat leptin deficiency associated with lipodystrophy. Myalept (metreleptin) is indicated as adjunct replacement therapy for complications of leptin deficiency in congenital or acquired generalized lipodystrophy (with compendial use in partial lipodystrophy with confirmed leptin deficiency and metabolic abnormalities).

Covered Indications

The following are considered covered when all approval criteria are met and the member has no exclusions to the prescribed therapy:

FDA-approved indication: adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy

Compendial use: Partial lipodystrophy in patients with confirmed leptin deficiency and metabolic abnormalities

Exclusions and Not Medically Necessary

Exclusions (Not Covered)

Coverage will not be provided for members with any of the following exclusions:

Generalized obesity not associated with generalized lipodystrophy

HIV-related lipodystrophy

Not Medically Necessary / Experimental

All other indications are considered experimental/investigational and not medically necessary, including:

Use for treatment of liver disease, including nonalcoholic steatohepatitis (NASH) — safety and effectiveness not established

Treatment of complications of partial lipodystrophy (safety and effectiveness not established)

Use in patients with metabolic disease (including diabetes mellitus and hypertriglyceridemia) without concurrent evidence of congenital or acquired generalized lipodystrophy

Provider Actions & Authorization Workflow

Prior Authorization

Prior authorization required

Prior authorization is required. Submission of a leptin level is necessary to initiate the prior authorization review for initial requests. When approval criteria are met, initial authorizations may be granted for 6 months; continuation authorizations may be granted for 12 months.

Documentation Required

Documentation of diagnosis and metabolic complications

For initial approval, document the member's diagnosis (congenital or acquired generalized lipodystrophy or partial lipodystrophy), confirm leptin deficiency with a laboratory leptin level < 12 ng/ml, and document at least one lipodystrophy complication (e.g., diabetes mellitus, hypertriglyceridemia, increased fasting insulin). For continuation approval, document improvement from baseline in metabolic control (examples: improved glycemic control, decreased triglycerides, decreased hepatic enzyme levels).

Clinical Evidence

Evidence (Primary references): Package insert (February 2022) and multiple clinical guideline and observational studies are cited as the primary references. Specific cited sources include the Myalept package insert (Feb 2022) and guideline/observational studies such as J Clin Endocrinol Metab 2016, Endocr Pract 2011, and Endocrine 2019.

Background & Definitions

Background: Myalept (metreleptin) 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. Safety and effectiveness have not been established for several other uses, including treatment of liver disease such as nonalcoholic steatohepatitis (NASH), treatment of complications of partial lipodystrophy, use in patients with HIV-related lipodystrophy, and use in patients with metabolic disease (including diabetes mellitus and hypertriglyceridemia) without concurrent evidence of congenital or acquired generalized lipodystrophy.

Definitions

Leptin deficiencyLaboratory leptin level less than 12 ng/ml as specified for coverage

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMyalept (metreleptin) coverage for lipodystrophy

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

On This Page

OpenPayer

Myalept (metreleptin) coverage for lipodystrophy

Coverage Summary

Initial Authorization Criteria (6 months)

Continuation Authorization Criteria (12 months)

Exclusions and Not Medically Necessary

Provider Actions & Authorization Workflow

Applicable Codes

Clinical Evidence

Background & Definitions

Revision History