CurrentConnectiCarePolicy C17341-A

Myalept (metreleptin) Coverage Criteria

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Prior authorization coverage for Myalept subcutaneous injection for complications of leptin deficiency in members with congenital or acquired generalized lipodystrophy, including initial and continuation criteria, documentation requirements, dosing limits, and administration setting.

Policy Summary

PayerConnectiCare

PolicyMyalept (metreleptin) Coverage Criteria

Policy CodePolicy C17341-A

Change TypeRevision — no material clinical or coverage changes

Effective DateMay 30, 2026

Next Review DateApril 1, 2027

Key ActionDocument generalized lipodystrophy, confirmed leptin deficiency, a qualifying persistent metabolic complication despite optimized treatment, and no unaddressed contraindication when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsInitial authorization

12 monthsContinuation authorization

10 mg/dayMaximum dose

<6 ng/mLPediatric leptin threshold

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CurrentConnectiCarePolicy C17341-A

Myalept (metreleptin) Coverage Criteria

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Policy Summary

PayerConnectiCare

PolicyMyalept (metreleptin) Coverage Criteria

Policy CodePolicy C17341-A

Change TypeRevision — no material clinical or coverage changes

Effective DateMay 30, 2026

Next Review DateApril 1, 2027

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsInitial authorization

12 monthsContinuation authorization

10 mg/dayMaximum dose

<6 ng/mLPediatric leptin threshold

HbA1c >7% or TG >250 mg/dLMetabolic complication threshold

Coverage Criteria

Initial Therapy

Covered when ALL of the following criteria are met:

ALL of the following

Documented diagnosis of congenital (e.g., Berardinelli-Seip syndrome) or acquired (e.g., Lawrence syndrome) generalized lipodystrophy associated with leptin deficiency.
Leptin deficiency confirmed by Linco assay obtained after an overnight fast
- Females: circulating leptin level <12 ng/mL.
- Males: circulating leptin level <8 ng/mL.
- Children ages 6 months through 5 years: circulating leptin level <6 ng/mL.
At least ONE of the following metabolic complications is documented
- ALL of the following
  - Diabetes mellitus or insulin resistance with persistent hyperglycemia.HgA1c > 7%
  - Dietary intervention has been attempted.
  - Optimized insulin therapy has been used at maximum tolerated doses.
- ALL of the following
  - Persistent hypertriglyceridemia.TG >250 mg/dL
  - Dietary intervention has been attempted.
The prescriber attests, or the clinical reviewer determines, that the member does not have any FDA-labeled contraindications that have not been addressed in the submitted documentation. Contraindications include general obesity not associated with congenital leptin deficiency and hypersensitivity to metreleptin.

Continuation Therapy

Continuation coverage is provided when ALL of the following criteria are met:

ALL of the following

Documentation demonstrates a positive clinical response to therapy, such as improved glycemic control, decreased hepatic enzyme levels, sustained improvement in triglyceride levels, or a decrease in hemoglobin A1c from baseline.
Documentation demonstrates that the member continues on an optimized hyperglycemia or hypertriglyceridemia treatment regimen.
The prescriber attests, or the clinical reviewer determines, that there is no evidence of intolerable adverse effects or drug toxicity.

FDA-Approved Generalized Lipodystrophy Indication

Myalept is covered for the following FDA-approved use:

As an adjunct to diet, as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.

The safety and effectiveness of Myalept for the treatment of complications of partial lipodystrophy have not been established.

The safety and effectiveness of Myalept for the treatment of liver disease, including nonalcoholic steatohepatitis (NASH), have not been established.

Myalept is not indicated for use in patients with HIV-related lipodystrophy.

Myalept is not indicated for use in patients with metabolic disease, including diabetes mellitus and hypertriglyceridemia, without concurrent evidence of congenital or acquired generalized lipodystrophy.

Myalept is contraindicated for general obesity not associated with congenital leptin deficiency and for hypersensitivity to metreleptin.

FDA-labeled limitations of use and excluded clinical situations apply. Myalept is not established or indicated for partial lipodystrophy complications, liver disease including NASH, HIV-related lipodystrophy, or metabolic disease without concurrent congenital or acquired generalized lipodystrophy. All other uses of Myalept (metreleptin) are considered experimental/investigational and are subject to the applicable off-label policy.

Coverage is excluded for general obesity not associated with congenital leptin deficiency and for patients with hypersensitivity to metreleptin.

Coding and Clinical Thresholds

HCPCS CodeHCPCS

Female circulating leptin threshold

Test methodConfirmed by Linco assay after an overnight fast

Applicable populationFemales

Circulating leptin threshold<12 ng/mL

Male circulating leptin threshold

Test methodConfirmed by Linco assay after an overnight fast

Applicable populationMales

Circulating leptin threshold<8 ng/mL

Prior Authorization and Provider Requirements

Prior Authorization

Initial Prior Authorization Criteria

Submit documentation supporting the diagnosis, confirmed leptin deficiency, qualifying metabolic complication despite optimized treatment, absence of unaddressed FDA-labeled contraindications, and required specialist involvement for initial authorization.

Documented congenital or acquired generalized lipodystrophy associated with leptin deficiency.
Confirmed fasting Linco assay leptin deficiency: females <12 ng/mL, males <8 ng/mL, or children 6 months–5 years <6 ng/mL.
At least one qualifying complication: persistent hyperglycemia (HbA1c >7%) despite dietary intervention and optimized insulin at maximum tolerated doses; or persistent triglycerides >250 mg/dL despite dietary intervention and at least two triglyceride-lowering agents from different classes at maximum tolerated doses.
Prescriber attestation or clinical review confirming no unaddressed FDA-labeled contraindication.
Prescribed by or in consultation with an endocrinologist or geneticist; submit consultation notes when available.
Initial authorization is approved for 12 months.

Prior Authorization

Clinical Background

Myalept (metreleptin) is a recombinant human leptin analog used as an adjunct to diet and as replacement therapy for complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. Generalized lipodystrophy is characterized by loss or insufficient distribution of adipose tissue and may be associated with severe metabolic abnormalities.

Definitions

Confirmed leptin deficiency

Confirmation methodLinco assay obtained after an overnight fast

Female thresholdCirculating leptin <12 ng/mL

Male thresholdCirculating leptin <8 ng/mL

Children aged 6 months through 5 yearsCirculating leptin <6 ng/mL

Generalized lipodystrophy

DefinitionA congenital or acquired disorder characterized by generalized loss of adipose tissue

Congenital exampleBerardinelli-Seip syndrome

Initial Therapy

Myalept Initial Therapy

Initial therapy requires ALL of the following, including at least ONE qualifying metabolic complication:

Myalept initial therapy

Generalized lipodystrophy with confirmed leptin deficiency: The member has documented congenital or acquired generalized lipodystrophy associated with leptin deficiency, with confirmed leptin deficiency measured by Linco assay after an overnight fast.
Applicable leptin thresholds: females <12 ng/mL; males <8 ng/mL; children aged 6 months through 5 years <6 ng/mL.
At least ONE qualifying metabolic complication
- Diabetes mellitus or insulin resistance with persistent hyperglycemia despite dietary intervention and optimized insulin therapy at maximum tolerated doses.HbA1c >7%

Continuation Therapy

Myalept Continuation Therapy

Continuation of therapy requires ALL of the following:

Myalept continuation therapy

Positive clinical response: Documentation of positive clinical response to therapy, such as improved glycemic control, decreased hepatic enzyme levels, sustained improvement in triglyceride levels, or decreased hemoglobin A1c from baseline.
Continued optimized treatment: Documentation that the member continues on an optimized hyperglycemia or hypertriglyceridemia treatment regimen.
No intolerable adverse effects or drug toxicity: The prescriber attests, or the clinical reviewer determines, that there is no evidence of intolerable adverse effects or drug toxicity.

Quantity and Dose Limits

Myalept maximum dose quantity limit

DrugMyalept (metreleptin)

Maximum quantity1 vial

Maximum dose10 mg per day

Administration Setting

Billing Rule

Use home administration and pharmacy benefit coverage

Injectable Myalept is recommended for pharmacy benefit coverage and patient self-administration at home.

Policy Summary

PayerConnectiCare

PolicyMyalept (metreleptin) Coverage Criteria

Policy CodePolicy C17341-A

Change TypeRevision — no material clinical or coverage changes

Effective DateMay 30, 2026

Next Review DateApril 1, 2027

SourceLink

On This Page

Optimized therapy with at least two triglyceride-lowering agents from different classes (e.g., statins, fibrates) has been used at maximum tolerated doses.

Pediatric circulating leptin threshold

Test methodConfirmed by Linco assay after an overnight fast

Applicable populationChildren aged 6 months through 5 years

Circulating leptin threshold<6 ng/mL

Persistent hyperglycemia threshold

ConditionDiabetes mellitus or insulin resistance with persistent hyperglycemia

HbA1c threshold>7%

Required treatmentDietary intervention and optimized insulin therapy at maximum tolerated doses

Persistent hypertriglyceridemia threshold

ConditionPersistent hypertriglyceridemia

Triglyceride threshold>250 mg/dL

Required treatmentDietary intervention and optimized therapy with at least two triglyceride-lowering agents from different classes at maximum tolerated doses

Maximum Myalept dose and vial limitation

MedicationMyalept (metreleptin)

Maximum daily dose10 mg/day

Vial limitation1 vial per day

Reauthorization Criteria

For reauthorization, provide evidence that Myalept continues to benefit the member, that treatment for the qualifying metabolic complication remains optimized, and that therapy remains tolerable and safe.

Document positive clinical response, such as improved glycemic control, decreased hepatic enzyme levels, sustained triglyceride improvement, or a decrease in hemoglobin A1c from baseline.
Document continued optimized hyperglycemia or hypertriglyceridemia treatment.
Prescriber attestation or clinical review confirming no intolerable adverse effects or drug toxicity.
Continuation authorization is approved for 12 months.

Prior Authorization

Myalept REMS Prior Authorization Requirements

Myalept is available only through the restricted Myalept REMS Program because of risks including anti-metreleptin antibodies that may neutralize endogenous leptin and/or Myalept and the risk of lymphoma.

Prescribers must be certified with the Myalept REMS Program.
Pharmacies must be certified and may dispense Myalept only after receiving the Myalept REMS Prescription Authorization Form for each new prescription.
Additional information: www.myaleptrems.com or 1-855-669-2537.

Documentation Required

Medical Records and Dosing Information

Include complete medical records and member-specific dosing information needed for the coverage review. Additional documentation may be requested on a case-by-case basis.

Submit relevant patient records, test results, and provider credentials when requested.
When dosing is based on weight, body surface area, or another member-specific measurement, include that measurement.
Documentation must support medical necessity, non-investigational use, and coverage within the member’s benefits.

Documentation Required

Diagnosis and Confirmed Leptin Deficiency

Document congenital or acquired generalized lipodystrophy and confirm leptin deficiency using a fasting Linco assay.

Examples of congenital generalized lipodystrophy include Berardinelli-Seip syndrome; an example of acquired generalized lipodystrophy is Lawrence syndrome.
Fasting leptin thresholds: females <12 ng/mL; males <8 ng/mL; children 6 months–5 years <6 ng/mL.

Prior Authorization

Metabolic Complications and Contraindications

Document at least one qualifying metabolic complication despite required interventions and address FDA-labeled contraindications before requesting coverage.

Persistent hyperglycemia requires HbA1c >7% despite dietary intervention and optimized insulin therapy at maximum tolerated doses.
Persistent hypertriglyceridemia requires triglycerides >250 mg/dL despite dietary intervention and optimized therapy with at least two triglyceride-lowering agents from different classes at maximum tolerated doses.
Coverage requires no unaddressed contraindication, including general obesity not associated with congenital leptin deficiency or hypersensitivity to metreleptin.

Documentation Required

Specialist Consultation Notes

Myalept must be prescribed by or in consultation with an endocrinologist or geneticist. Include consultation notes with the initial request and reauthorization requests when available.

Submit the relevant specialist consultation documentation with each applicable coverage request.

Unsupported block type: documentation

Prior Authorization

Myalept REMS Prescription Authorization Form

Myalept prescriptions are subject to the Myalept REMS Program. Pharmacies require a completed Myalept REMS Prescription Authorization Form for each new prescription before dispensing.

Ensure the form is completed and submitted as required for each new prescription.
Pharmacies must be REMS-certified.

Prior Authorization

Prescriber REMS Certification

Prescribers must enroll in the Myalept REMS Program, complete required training, and obtain certification before prescribing Myalept.

Prescriber certification is required for participation in the restricted distribution program.

Denial Risk

FDA-Labeled Contraindications

Myalept is contraindicated for general obesity not associated with congenital leptin deficiency and for patients with hypersensitivity to metreleptin. Address any contraindication in the submitted documentation; unaddressed contraindications may prevent coverage.

General obesity without congenital leptin deficiency.
Hypersensitivity to metreleptin.

Denial Risk

FDA-Labeled Limitations of Use

The safety and effectiveness of Myalept have not been established for complications of partial lipodystrophy or for liver disease, including nonalcoholic steatohepatitis.

Myalept is not indicated for HIV-related lipodystrophy.
Myalept is not indicated for metabolic disease, including diabetes mellitus or hypertriglyceridemia, without concurrent congenital or acquired generalized lipodystrophy.

Denial Risk

Insufficient Documentation May Result in Denial

Insufficient supporting documentation may result in denial or other appropriate action. The plan may request additional records, test results, or provider credentials to validate medical necessity and benefit eligibility.

Documentation must support that the drug is medically necessary, not investigational or experimental, and within the scope of benefits.
Documentation demonstrating inappropriate or excessive billing or other improper practice may result in denial or additional action.

Denial Risk

Noncovered Use Outside Approved Indication

Use of Myalept outside the approved generalized lipodystrophy indication is not covered under these criteria and may be denied.

Do not request coverage for metabolic disease without concurrent congenital or acquired generalized lipodystrophy.
Partial lipodystrophy complications, liver disease including NASH, and HIV-related lipodystrophy are outside the labeled indications.

Denial Risk

Experimental or Investigational Use

All other uses of Myalept are considered experimental or investigational and are subject to the applicable off-label policy.

Coverage is not established for uses outside the approved generalized lipodystrophy indication unless separately supported under the applicable off-label policy.

Denial Risk

Contraindicated Conditions

Coverage may be denied when the member has a contraindicated condition that is not addressed by the prescriber in the submitted documentation.

General obesity not associated with congenital leptin deficiency.
Hypersensitivity to metreleptin.

Denial Risk

REMS Noncompliance May Result in Denial

Failure to satisfy Myalept REMS requirements may result in denial or inability to dispense the medication.

Prescriber must be enrolled, trained, and certified with the Myalept REMS Program.
The dispensing pharmacy must be REMS-certified.
A Myalept REMS Prescription Authorization Form is required for each new prescription.

Acquired exampleLawrence syndrome

Generalized lipodystrophy: clinical characteristics

DescriptionA rare disorder characterized by abnormal adipose-tissue distribution and insufficient fat tissue

Characteristic findingLoss of subcutaneous adipose tissue

Associated abnormalitiesSevere metabolic abnormalities, such as diabetes mellitus and hypertriglyceridemia

Congenital generalized lipodystrophy

InheritanceAutosomal recessive disorder

OnsetApparent from birth

Distribution of adipose-tissue lossAffects the limbs, trunk, face, and neck; muscularity and visible subcutaneous veins may also occur

Acquired generalized lipodystrophy

DefinitionGeneralized lipodystrophy that develops after birth

Associated conditionsMay occur with panniculitis or autoimmune conditions

CourseMay be idiopathic and may develop over weeks to years, often in childhood or adolescence

Myalept REMS Program

Program typeRestricted distribution and safety program under a REMS

Prescriber requirementPrescribers must enroll, complete training, and become certified

Pharmacy and dispensing requirementPharmacies must be certified and may dispense only after receiving the Myalept REMS Prescription Authorization Form for each new prescription

Persistent hypertriglyceridemia despite dietary intervention and optimized therapy with at least two triglyceride-lowering agents from different classes at maximum tolerated doses.TG >250 mg/dL

No unaddressed FDA-labeled contraindication: The prescriber attests, or the clinical reviewer determines, that the member has no FDA-labeled contraindication that has not been addressed in the submitted documentation.

Contraindications include general obesity not associated with congenital leptin deficiency and hypersensitivity to metreleptin.

Initial Coverage — FDA-Approved Use

Initial coverage is limited to the FDA-approved use:

FDA-approved use: The patient has congenital or acquired generalized lipodystrophy with complications of leptin deficiency, and Myalept will be used as replacement therapy adjunctive to diet.