CurrentUnitedHealthcarePolicy 2025 P 1132-13

Pa Notification Myalept

UnitedHealthcare prior authorization/notification program for Myalept (metreleptin) specifying initial and reauthorization clinical criteria, REMS requirement note, authorization duration, and additional clinical rules including potential automated approvals and supply limits.

Policy Summary

PayerUnitedHealthcare

PolicyPa Notification Myalept

Policy CodePolicy 2025 P 1132-13

Change TypeAnnual review (no coverage changes)

Effective DateAug 1, 2025

Next Review Date

Key ActionPrior authorization/notification required for Myalept; approvals issued for 12 months for both initial authorization and reauthorization.

SourceLink

POLICY UPDATE CHANGES

Annual review 5/2025: Annual review with no changes to coverage criteria; updated background and reference.

12 monthsAuthorization duration

REMSRisk management

Partial/NASH/HIV-relatedExcluded/Not established indications

Coverage Summary

Coverage stance: covered_with_criteria. Authorization duration: 12 months for both initial authorization and reauthorization. REMS requirement: REMS required — Myalept is available only through the Myalept REMS restricted program due to risks of anti-metreleptin (neutralizing) antibodies and lymphoma. Excluded indications: partial lipodystrophy, liver disease including NASH, HIV-related lipodystrophy, and metabolic disease without generalized lipodystrophy.

Initial Therapy Criteria

Initial Authorization

Myalept will be approved when ALL of the following are met:

ALL of the following

Diagnosis of congenital or acquired generalized lipodystrophy associated with leptin deficiency
Myalept is being used as an adjunct to diet modification

Continuation Therapy Criteria

Reauthorization (Continuation Therapy)

Myalept will be approved for reauthorization when ALL of the following are met:

ALL of the following

Documentation of positive clinical response to Myalept therapy
Myalept is being used as an adjunct to diet modification

Limitations of Use and Exclusions

Limitations of Use / Exclusions

Not indicated for

Partial lipodystrophy (safety and effectiveness not established)
Treatment of liver disease including nonalcoholic steatohepatitis (NASH) (safety and effectiveness not established)
Patients with HIV-related lipodystrophy
Patients with metabolic disease without concurrent evidence of generalized lipodystrophy

ALL of the following

Myalept is available only through the Myalept REMS restricted program due to risk of neutralizing anti-metreleptin antibodies and lymphoma

Myalept (metreleptin) is a leptin analog indicated as an adjunct to diet to treat complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. It is available only through a REMS program because of risks of neutralizing anti-metreleptin antibodies and lymphoma. Not indicated for: partial lipodystrophy, treatment of liver disease including nonalcoholic steatohepatitis (NASH), patients with HIV-related lipodystrophy, or patients with metabolic disease without concurrent evidence of generalized lipodystrophy.

Provider Actions / Requirements

Prior Authorization

Prior authorization required

Prior authorization/notification required; approvals issued for 12 months.

Documentation Required

Clinical documentation for initial approval

Provide documentation of diagnosis of congenital or acquired generalized lipodystrophy associated with leptin deficiency and confirm Myalept will be used as an adjunct to diet modification.

Documentation Required

Clinical documentation for reauthorization

Provide documentation of positive clinical response to Myalept therapy and confirm ongoing use as an adjunct to diet modification.

Documentation Required

REMS program requirement

Ensure patient enrollment/requirements per the Myalept REMS restricted program are met due to risk of neutralizing antibodies and lymphoma.

Denial Risk

Not indicated populations

Claims for partial lipodystrophy, NASH, HIV-related lipodystrophy, or metabolic disease without generalized lipodystrophy may be denied as not supported by indications.

Billing Rule

Automated approval processes may apply

UnitedHealthcare may approve initial and re-authorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; use of automated processes varies by program.

Billing Rule

Supply limits

Supply limits may be in place; ensure adherence to any quantity/supply constraints in the benefit system.

Clinical Evidence & References

Evidence and references: Myalept [package insert], Chiesi USA, Inc.; March 2024. UnitedHealthcare criteria supporting use include initial authorization when there is a diagnosis of congenital or acquired generalized lipodystrophy associated with leptin deficiency and Myalept is used as an adjunct to diet modification; reauthorization requires documentation of positive clinical response to Myalept and continued use as an adjunct to diet modification. Authorization is issued for 12 months for both initial and reauthorization.

Background / Definitions

Indication and REMS: Myalept (metreleptin) is indicated as adjunct to diet as replacement therapy to treat complications of leptin deficiency in congenital or acquired generalized lipodystrophy. Myalept is available only through the Myalept REMS restricted program due to risks of neutralizing anti-metreleptin antibodies and lymphoma. Definition: REMS — Risk Evaluation and Mitigation Strategy; a restricted program required for Myalept because of risks of anti-metreleptin antibodies and lymphoma. Not indicated for partial lipodystrophy, liver disease including NASH, HIV-related lipodystrophy, or metabolic disease without generalized lipodystrophy.

Revision History

5/2014annual_review

Program created (New program) and initial P&T approval.

5/2015annual_review

Annual review (no changes to coverage criteria); references updated.

5/2016annual_review

Annual review (no changes to coverage criteria); updated reference.

5/2017annual_review

Annual review with no changes to coverage criteria.

5/2018annual_review

Annual review with no changes to coverage criteria.

12/2018administrative_update

Administrative change to add statement regarding use of automated processes.

5/2019annual_review

Annual review with no changes to coverage criteria.

5/2020annual_review

Annual review; added information related to REMS program and corrected trademark information.

5/2021annual_review

Annual review with no changes to coverage criteria; updated reference.

5/2022annual_review

Annual review; updated reference.

5/2023annual_review

Annual review with no changes to coverage criteria; added state mandate footnote.

5/2024annual_review

Annual review with no changes to coverage criteria.

5/2025annual_reviewLatest

Annual review with no changes to coverage criteria; updated background and reference.

Policy Summary

PayerUnitedHealthcare

PolicyPa Notification Myalept

Policy CodePolicy 2025 P 1132-13

Change TypeAnnual review (no coverage changes)

Effective DateAug 1, 2025

Next Review Date

Key ActionPrior authorization/notification required for Myalept; approvals issued for 12 months for both initial authorization and reauthorization.

SourceLink

On This Page

OpenPayer

Pa Notification Myalept

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Limitations of Use and Exclusions

Applicable Codes

Provider Actions / Requirements

Clinical Evidence & References

Background / Definitions

Revision History