CurrentNeighborhood Health Plan of Rhode IslandPolicy 1674-A

Myalept (metreleptin) — Coverage Criteria for Lipodystrophy

Defines coverage and prior authorization criteria for Myalept (metreleptin) to treat complications of leptin deficiency in members with generalized or certain partial lipodystrophy; applies to prescribers and prior authorization reviewers for Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMyalept (metreleptin) — Coverage Criteria for Lipodystrophy

Policy CodePolicy 1674-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documented leptin level (< 12 ng/mL), diagnosis, and at least one lipodystrophy-related complication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial authorization duration

12 mocontinuation authorization duration

<12 ng/mLlaboratory threshold

HIV-relatedexplicit exclusion

Generalized obesityexplicit exclusion

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Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met

Initial authorization for lipodystrophy: A. Member has a diagnosis of congenital generalized lipodystrophy (e.g., Berardinelli-Seip syndrome), acquired generalized lipodystrophy (e.g., 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)leptin < 12 ng/mL

Authorization of 6 months may be granted if all criteria are met.

Continuation Therapy

Covered when ALL of the following are met

Continuation authorization: Member requesting continuation has experienced improvement from baseline in metabolic control (e.g., improved glycemic control, decrease in triglycerides, decrease in hepatic enzyme levels)clinical/metabolic improvement

Authorization of 12 months may be granted.

Compendial Use

Covered when ALL of the following are met

Compendial-use partial lipodystrophy: Partial lipodystrophy in patients with confirmed leptin deficiency and metabolic abnormalitiesleptin deficiency documented

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

Coverage exclusions and limitations include use for partial lipodystrophy without confirmed leptin deficiency; treatment of liver disease, including nonalcoholic steatohepatitis (NASH); HIV-related lipodystrophy; and generalized obesity not associated with generalized lipodystrophy.

Any request for Myalept for indications beyond the FDA‑approved indication and the compendial use for partial lipodystrophy with confirmed leptin deficiency and metabolic abnormalities is considered experimental/investigational and not medically necessary.

Drug and Diagnostic Coding

Drug referencedmixed

metreleptin

Myalept (metreleptin) — branded drug name referenced in policy

Leptin level threshold

Leptin level thresholdLaboratory-confirmed leptin deficiency defined as less than 12 ng/mL

Documentation required for initial requestsSubmit leptin level result with initial prior authorization request

Use in criteria setsThreshold used to determine eligibility for initial, continuation, and compendial-use criteria

Prior Authorization, Documentation, and Workflow

Prior Authorization

Prior Authorization Required

Prior authorization is required for Myalept (metreleptin) for treatment of lipodystrophy.

Initial prior authorization duration: up to 6 months
Continuation prior authorization duration: up to 12 months (requires documentation of clinical improvement from baseline, e.g., improved glycemic control, decreased triglycerides, decreased hepatic enzyme levels)

Step Therapy

No step therapy requirements specified for metreleptin; providers are not required to try alternative therapies prior to prior authorization approval.

Clinical Background and Indications

Myalept (metreleptin) is a leptin replacement therapy indicated as an adjunct to diet to treat complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. Evidence for use in partial lipodystrophy is limited to patients with laboratory‑confirmed leptin deficiency and metabolic abnormalities.

Key Definitions

Leptin deficiency

DefinitionLaboratory-confirmed low leptin level defined in this policy as less than 12 ng/mL

Role in coverageRequired to meet initial authorization criteria for lipodystrophy (criterion B)

Required documentationLeptin level must be submitted with initial prior authorization request

Generalized lipodystrophy

Congenital generalized lipodystrophyBerardinelli-Seip syndrome

Acquired generalized lipodystrophyLawrence syndrome

Coverage implication