CurrentNeighborhood Health Plan of Rhode IslandPolicy 1674-A

Myalept (metreleptin) coverage policy

Defines coverage, prior authorization documentation, inclusion/exclusion criteria, and authorization durations for Myalept (metreleptin) for treatment of complications of leptin deficiency in congenital or acquired generalized lipodystrophy and select compendial uses.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMyalept (metreleptin) coverage policy

Policy CodePolicy 1674-A

Change TypeClarified

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documented leptin level for initial requests; include diagnosis and evidence of at least one lipodystrophy-related complication.

SourceLink

POLICY UPDATE CHANGES

Policy lists FDA-approved indications, compendial uses, documentation requirements (leptin level) and authorization durations (6 months initial, 12 months continuation).

2FDA-Approved Indications (listed)

1Compendial use listed

2Explicit exclusions

Coverage Summary

Myalept (metreleptin) is covered with criteria as an adjunct replacement therapy for complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy, consistent with the FDA indication. The policy defines required prior authorization documentation (including a documented leptin level for initial requests), authorization durations (6 months for initial authorization and 12 months for continuation), and includes a listed compendial use for partial lipodystrophy when criteria are met.

Initial Therapy Criteria (6-month authorization)

Covered Indications - Initial Authorization for Lipodystrophy

Authorization of 6 months may be granted for treatment of lipodystrophy when ALL of the following criteria are met:

ALL of the following

Diagnosis: Member has a diagnosis of congenital generalized lipodystrophy (Berardinelli-Seip syndrome), acquired generalized lipodystrophy (Lawrence syndrome), or partial lipodystrophy
Leptin deficiency: Member has leptin deficiency confirmed by laboratory testing< 12 ng/ml
Leptin level required for initial requests (documented value)
Complication: Member has at least one complication of lipodystrophy (e.g., diabetes mellitus, hypertriglyceridemia, increased fasting insulin level)

Prior Authorization

Prior authorization requirement and required documentation

Submit a prior authorization for initial requests that includes a documented leptin level, the diagnosis, and evidence of at least one lipodystrophy-related complication.

Leptin threshold: < 12 ng/ml

Continuation Therapy Criteria (12-month authorization)

Continuation Authorization for Lipodystrophy

Authorization of 12 months may be granted for continuation when ALL of the following are met:

ALL of the following

Current therapy: Member is currently receiving Myalept for lipodystrophy
Clinical improvement: Member has experienced improvement from baseline in metabolic control
Examples include improved glycemic control, decrease in triglycerides, decrease in hepatic enzyme levels

Documentation Required

Continuation documentation — evidence of clinical improvement

For continuation (renewal) requests, provide objective evidence of improvement from baseline in metabolic control. Examples include improved glycemic control, decreased triglycerides, or decreased hepatic enzyme levels.

Compendial Use (Partial Lipodystrophy)

Covered as a compendial use when criteria met:

Partial lipodystrophy (compendial): Partial lipodystrophy in patients with confirmed leptin deficiency and metabolic abnormalities< 12 ng/ml

Follow same leptin confirmation requirement (< 12 ng/ml) and documentation

Not Medically Necessary / Exclusions

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

Exclusions

HIV-related lipodystrophy
Generalized obesity not associated with generalized lipodystrophy
Other indications: Indications not listed in FDA-approved indications or compendial uses (all other indications are considered experimental/investigational and not medically necessary)

Provider Actions & Documentation

Documentation Required

Continuation evidence requirements and authorization durations

Continuation documentation and authorization durations: For continuation, submit objective evidence of improvement from baseline in metabolic control (e.g., improved glycemic control, decreased triglycerides, decreased hepatic enzyme levels). Authorization durations: initial approval may be granted for 6 months; continuation approvals may be granted for 12 months.

Clinical Evidence & Background

The package insert states that the safety and effectiveness of Myalept have not been established for treatment of complications of partial lipodystrophy and for liver disease, including NASH. It also specifies that Myalept is not indicated for HIV-related lipodystrophy and is not indicated for use in patients with metabolic disease (such as diabetes mellitus and hypertriglyceridemia) without concurrent evidence of congenital or acquired generalized lipodystrophy.

Definitions

DefinitionLaboratory leptin level less than 12 ng/ml as specified in policy