CurrentMolina HealthcarePolicy C25604-A

Elfabrio for Fabry Disease

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Coverage and prior authorization for intravenous Elfabrio (pegunigalsidase alfa-iwxj) in adults with confirmed Fabry disease under the pharmacy or medical benefit, subject to eligibility and clinical criteria.

Policy Summary

PayerMolina Healthcare

PolicyElfabrio for Fabry Disease

Policy CodePolicy C25604-A

Change TypeNo material change

Effective DateSeptember 19, 2026

Next Review DateJuly 1, 2027

Key ActionSubmit prior authorization with diagnostic confirmation, baseline disease status, treatment goals, qualified prescriber documentation, and confirmation that concurrent Fabry-specific therapy will not be used.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum age

1 mg/kgDose

Every 2 weeksFrequency

12 monthsInitial authorization

12 months

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CurrentMolina HealthcarePolicy C25604-A

Elfabrio for Fabry Disease

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Policy Summary

PayerMolina Healthcare

PolicyElfabrio for Fabry Disease

Policy CodePolicy C25604-A

Change TypeNo material change

Effective DateSeptember 19, 2026

Next Review DateJuly 1, 2027

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum age

1 mg/kgDose

Every 2 weeksFrequency

12 monthsInitial authorization

12 months

Continuation authorization

Coverage Criteria

Initial Therapy

Initial coverage requires ALL of the following conditions.

Initial therapy

Age and prescriber requirements
- The member is 18 years of age or older.18 years and older
- The medication is prescribed by or in consultation with a board-certified nephrologist, cardiologist, neurologist, endocrinologist, clinical geneticist, clinical biochemical geneticist, or a physician experienced in the management of Fabry disease.
  If prescribed in consultation, submit consultation notes with the initial request.
Diagnosis
- The member has documented classic Fabry disease with typical clinical manifestations, confirmed by deficient alpha-galactosidase A (α-Gal A) enzyme activity in plasma, isolated leukocytes, or cultured cells, and/or molecular genetic testing identifying a GLA mutation.Males with classic Fabry disease have less than 1% α-Gal A enzyme activity
  Documentation is required.
- The member is diagnosed as a Fabry disease carrier with significant clinical manifestations, confirmed by a documented decrease in α-Gal A enzyme activity in plasma and/or isolated leukocytes and/or molecular genetic testing to clarify genetic status.
  Documentation is required.
Baseline disease status or clinical need
- Baseline disease status is documented using the Mainz Severity Score Index (MSSI) or FOS Mainz Severity Score Index.
- Objective or subjective clinical information, including signs and symptoms, documents sufficient clinical manifestations to justify treatment and includes at least one qualifying manifestation: pain in the extremities, hypohidrosis, corneal opacities, kidney dysfunction, cardiac dysfunction, or cerebrovascular disorders.
  At least one listed manifestation is required.
- A baseline plasma globotriaosylceramide (GL-3 or Gb3) level is documented.
Treatment and nonconcurrent therapy requirements
- A treatment plan that includes goals of therapy is documented.
- Treatment will not be provided concurrently with Galafold (migalastat) or another enzyme replacement therapy for Fabry disease, including agalsidase beta (Fabrazyme).

Continuation Therapy

Continuation of coverage requires ALL of the following conditions.

Continuation therapy

Treatment response or stabilization
- The MSSI or FOS Mainz Severity Score Index shows improvement or stabilization.
- There is marked clinical improvement or stabilization in disease progression from baseline disease manifestations, such as kidney dysfunction or cardiac dysfunction.
- There is a reduction in plasma GL-3 and/or GL-3 inclusions compared with the pretreatment baseline.Compared with pretreatment baseline
The member is not receiving concurrent therapy with Galafold (migalastat) or another enzyme replacement therapy for Fabry disease, including agalsidase beta (Fabrazyme).

All other uses of Elfabrio (pegunigalsidase alfa) outside the covered indication for adults with confirmed Fabry disease are considered experimental or investigational and are subject to Molina’s Off-Label policy.

Concurrent therapy is not covered. Elfabrio must not be administered concurrently with Galafold (migalastat) or another Fabry disease enzyme replacement therapy, including agalsidase beta (Fabrazyme).

Diagnosis, Drug Coding, and Dose

FDA-approved diagnosisICD-10

E75.21

Fabry-Anderson disease

HCPCS codeHCPCS

J2508

Injection, pegunigalsidase alfa-iwxj, 1 mg

Elfabrio Dosing

Dose1 mg/kg

Weight basisActual body weight

FrequencyEvery 2 weeks

Diagnostic Enzyme Activity

PopulationMales with classic Fabry disease

α-Gal A activityLess than 1% of normal enzyme activity

Atypical Fabry diseaseResidual enzyme activity greater than 1% of normal

Authorization and Documentation Requirements

Prior Authorization

Initial Authorization Requirements

Prior authorization is required for initial coverage of Elfabrio (pegunigalsidase alfa). The request must establish that the member is an adult, the prescriber meets Molina’s qualification requirements, and the required clinical documentation supports medical necessity.

Member is 18 years of age or older.
Prescribed by or in consultation with a qualifying specialist or physician experienced in Fabry disease; consultation notes are required when applicable.
Submit diagnostic confirmation, baseline status, treatment goals, clinical rationale, and supporting records.
Elfabrio is not intended for concurrent use with Galafold or other Fabry disease enzyme replacement therapy.

Prior Authorization

Reauthorization Requirements

For reauthorization, submit records demonstrating ongoing benefit or stabilization and continued medical necessity. The member must not be receiving prohibited concurrent Fabry therapy, and the prescriber must attest to or clinical review must find no intolerable adverse effects or drug toxicity.

Disease and Treatment Background

Fabry disease is an X-linked lysosomal storage disorder caused by deficient activity of the lysosomal enzyme alpha-galactosidase A (α-Gal A). The deficiency causes accumulation of the substrate globotriaosylceramide (GL-3 or Gb3) in organs and tissues, including the kidneys, heart, nervous system, and blood vessels. Clinical manifestations may include pain, impaired peripheral sensation, hypohidrosis, corneal opacities, kidney dysfunction, cardiac dysfunction, and cerebrovascular disorders. Elfabrio is a pegylated enzyme replacement therapy indicated for adults with confirmed Fabry disease.

Key Definitions

Alpha-galactosidase A (α-Gal A)

DefinitionA lysosomal enzyme involved in the diagnosis of Fabry disease

Diagnostic relevanceDeficient α-Gal A activity supports a diagnosis of Fabry disease

Classic Fabry disease in malesGenerally less than 1% of normal α-Gal A enzyme activity

GL-3/Gb3

Full nameGlobotriaosylceramide

Also known asGL-3 or Gb3

Disease relevanceA substrate that accumulates in Fabry disease

Initial Therapy

Initial therapy requires ALL of the following conditions.

Initial Elfabrio therapy

Adult member
- The member is 18 years of age or older.18 years and older
Confirmed Fabry disease
- The member has documented classic Fabry disease with typical clinical manifestations, confirmed by deficient alpha-galactosidase A (α-Gal A) enzyme activity in plasma, isolated leukocytes, or cultured cells and/or molecular genetic testing identifying a GLA mutation.Males with classic Fabry disease have less than 1% α-Gal A enzyme activity
  Documentation is required.

Continuation Therapy

Continuation of coverage requires ALL of the following conditions.

Continuation of Elfabrio therapy

Documented response or stabilization
- The MSSI or FOS Mainz Severity Score Index shows improvement or stabilization.
- There is marked clinical improvement or stabilization in disease progression from baseline disease manifestations, such as kidney dysfunction or cardiac dysfunction.
- There is a reduction in plasma GL-3 and/or GL-3 inclusions compared with the pretreatment baseline.Compared with pretreatment baseline

Quantity and Administration Limits

Quantity Limits

MedicationElfabrio (pegunigalsidase alfa-iwxj)

Dose1 mg/kg

Weight basisActual body weight

Administration frequencyEvery 2 weeks

Administration Site Requirements

Billing Rule

Use an eligible infusion site

Administer infused Elfabrio under the Molina Health Care Site of Care program in a non-inpatient hospital facility-based location. Site-of-Care utilization management may channel Elfabrio to the prescription drug benefit for member self-administration when appropriate.

Policy Summary

PayerMolina Healthcare

PolicyElfabrio for Fabry Disease

Policy CodePolicy C25604-A

Change TypeNo material change

Effective DateSeptember 19, 2026

Next Review DateJuly 1, 2027

SourceLink

On This Page

The prescriber attests to, or the clinical reviewer has found, no evidence of intolerable adverse effects or drug toxicity, including severe hypersensitivity reactions or severe infusion-site reactions.

Continuation authorization is for 12 months.

Document improvement or stabilization using MSSI or FOS MSSI, clinical disease manifestations, or reduction in plasma GL-3 and/or GL-3 inclusions compared with baseline.
Provide supporting clinical records and treatment-response documentation.
Confirm no concurrent Galafold or other Fabry enzyme replacement therapy, including Fabrazyme.
Address severe hypersensitivity reactions, severe infusion-site reactions, or other intolerable adverse effects or drug toxicity.

Documentation Required

Clinical Records and Dosing Data

Submit complete medical rationale and supporting records for Molina’s coverage determination. When dosing is based on weight, body surface area, or another member-specific measurement, include that dosing information with the request.

Provide patient records, test results, and other documentation supporting medical necessity and non-investigational use.
Include the prescribed dose and the member-specific measurement used to calculate dosing, when applicable.
Molina may request additional documentation and may deny reimbursement when records do not support the determination.

Documentation Required

Diagnostic Confirmation

Document confirmed classic or atypical Fabry disease, or carrier status with significant clinical manifestations, using enzyme testing and/or molecular genetic confirmation as specified below.

For classic Fabry disease, document typical clinical manifestations and deficient α-galactosidase A enzyme activity in plasma, isolated leukocytes, and/or cultured cells; molecular testing identifying a GLA mutation may provide additional confirmation.
For carrier status, document significant clinical manifestations and decreased α-galactosidase A enzyme activity in plasma and/or isolated leukocytes, or provide molecular genetic testing to clarify genetic status.
Diagnostic documentation is required.

Unsupported block type: documentation

Prior Authorization

Prescriber Qualifications

Elfabrio must be prescribed by, or prescribed in consultation with, a qualified specialist or a physician experienced in Fabry disease management.

Qualifying specialists include a board-certified nephrologist, cardiologist, neurologist, endocrinologist, clinical geneticist, or clinical biochemical geneticist.
A physician experienced in the management of Fabry disease also qualifies.
If prescribed in consultation, submit consultation notes with the initial request and with each reauthorization request.

Documentation Required

Continuation Response

For continuation of therapy, document clinical benefit or stabilization relative to baseline using disease-severity measures, clinical findings, or biomarker response.

Improvement or stabilization on the MSSI or FOS MSSI.
Marked clinical improvement or stabilization in disease progression, such as kidney or cardiac dysfunction.
Reduction in plasma GL-3 and/or GL-3 inclusions compared with the pretreatment baseline.

Unsupported block type: denial_risk

Monitoring rolePlasma GL-3/Gb3 levels and GL-3 inclusions may be monitored as markers of disease response

MSSI/FOS MSSI

MSSIMainz Severity Score Index

FOS MSSIFOS Mainz Severity Score Index

Baseline useUsed to document baseline disease severity

Treatment-response useImprovement or stabilization may document treatment response

The member is diagnosed as a Fabry disease carrier with significant clinical manifestations, confirmed by a documented decrease in α-Gal A enzyme activity in plasma and/or isolated leukocytes and/or molecular genetic testing to clarify genetic status.

Documentation is required.

Qualifying clinical evidence

Baseline disease status is documented using the Mainz Severity Score Index (MSSI) or FOS Mainz Severity Score Index.
Objective or subjective clinical information documents sufficient manifestations to justify treatment and includes at least one of the following: pain in the extremities, hypohidrosis, corneal opacities, kidney dysfunction, cardiac dysfunction, or cerebrovascular disorders.
At least one listed manifestation is required.
A baseline plasma globotriaosylceramide (GL-3 or Gb3) level is documented.

Specialist and treatment requirements

The medication is prescribed by or in consultation with a board-certified nephrologist, cardiologist, neurologist, endocrinologist, clinical geneticist, clinical biochemical geneticist, or a physician experienced in the management of Fabry disease.
If prescribed in consultation, submit consultation notes with the initial request.
A treatment plan that includes goals of therapy is documented.
Treatment will not be provided concurrently with Galafold (migalastat) or another enzyme replacement therapy for Fabry disease, including agalsidase beta (Fabrazyme).

The member is not receiving concurrent therapy with Galafold (migalastat) or another enzyme replacement therapy for Fabry disease, including agalsidase beta (Fabrazyme).

Continuation authorization is for 12 months.