CurrentCommunity-CarePolicy N/A

Efgartigimod alfa/hyaluronidase (Vyvgart Hytrulo) — Medical Benefit Coverage Criteria

Defines medical necessity criteria, quantity limits, authorization period, and coding for efgartigimod alfa/hyaluronidase for CIDP and generalized myasthenia gravis (gMG) for providers and payers.

Policy Summary

PayerCommunity-Care

PolicyEfgartigimod alfa/hyaluronidase (Vyvgart Hytrulo) — Medical Benefit Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJul 1, 2025

Key ActionObtain prior authorization with neurologist documentation and required prior therapy trial records before requesting efgartigimod alfa/hyaluronidase.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Indications

4/28dQty limit (vial)

4/28dQty limit (PFS)

1 yrAuth period

J9334HCPCS

Coverage Criteria

Initial Therapy: Chronic inflammatory demyelinating polyneuropathy

Covered when ALL of the following are met:

CIDP initial: Diagnosis of chronic inflammatory demyelinating polyneuropathy.

CIDP initial: Prescribed by, or in consultation with, a neurologist.

CIDP initial: A trial of both of the following were ineffective, not tolerated, or both are contraindicated: (1) corticosteroid; (2) IV or SC immune globulin.

Initial Therapy: Generalized myasthenia gravis

Covered when ALL of the following are met:

Policy Summary

PayerCommunity-Care

PolicyEfgartigimod alfa/hyaluronidase (Vyvgart Hytrulo) — Medical Benefit Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJul 1, 2025

Key ActionObtain prior authorization with neurologist documentation and required prior therapy trial records before requesting efgartigimod alfa/hyaluronidase.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

gMG initial: Prescribed by, or in consultation with, a neurologist.

gMG initial: Diagnosis of generalized myasthenia gravis.

gMG initial: Positive serologic test for anti-acetylcholine antibodies.

gMG initial: Myasthenia Gravis Foundation of America (MGFA) Class II to IV.

gMG initial: Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score >= 5.MG-ADL >= 5

gMG initial: A trial of an acetylcholinesterase inhibitor that was ineffective, contraindicated, or not tolerated.

gMG initial: A trial of one of the following that was ineffective, not tolerated, or both are contraindicated: (1) oral corticosteroid; (2) oral non-steroidal immunosuppressant.

gMG initial: Will not be used in combination with other biologic therapies for myasthenia gravis.

Continuation Therapy: Chronic inflammatory demyelinating polyneuropathy

Covered when ALL of the following are met:

CIDP continuation: Diagnosis of chronic inflammatory demyelinating polyneuropathy.

CIDP continuation: Patient has demonstrated benefit with efgartigimod and hyaluronidase (Vyvgart Hytrulo).

Continuation Therapy: Generalized myasthenia gravis

Covered when ALL of the following are met:

gMG continuation: Diagnosis of generalized myasthenia gravis.

gMG continuation: Attestation of a positive clinical response to therapy.

gMG continuation: Not used in combination with other biologic therapies for myasthenia gravis.

Use of efgartigimod alfa/hyaluronidase (Vyvgart Hytrulo) in combination with other biologic therapies for myasthenia gravis is excluded and will not be approved.

Requests that do not document required prior therapy trials, lack prescribing or consult involvement from a neurologist, or do not meet the diagnostic criteria for the intended indication will be considered not medically necessary. For CIDP this includes absence of a trial of both a corticosteroid and IV or SC immune globulin that were ineffective, not tolerated, or contraindicated. For generalized myasthenia gravis this includes missing documentation of neurologist involvement, a positive anti‑acetylcholine antibody serologic test, MGFA Class II–IV, an MG‑ADL total score of ≥ 5, or trials of an acetylcholinesterase inhibitor and either an oral corticosteroid or an oral non‑steroidal immunosuppressant that were ineffective, not tolerated, or contraindicated.

Coding

Applicable HCPCS CodesHCPCSCovered

J9334

Injection, efgartigimod alfa and hyaluronidase

MG-ADL total score — threshold value used in criteria

MG-ADL total score threshold>= 5

Use in criteriaRequired for initial approval of generalized myasthenia gravis (one of the coverage criteria)

Reference in continuation criteriaBaseline MG-ADL score must be documented for initial approval; continued therapy requires attestation of positive clinical response

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — Requests for efgartigimod alfa/hyaluronidase (Vyvgart Hytrulo) must include documentation that the indication-specific criteria are met and that the prescribing clinician is a neurologist or the request is in consultation with a neurologist. Quantity limits and the one-year authorization period apply.

Quantity limits: up to 4 vials (22.4 mL) per 28 days or 4 prefilled syringes (20 mL) per 28 days.
Authorization period: up to 1 year (subject to benefit changes).

Documentation Required

Documentation requirements — Requests must include clear documentation of the diagnosis and a neurologist's note (or documentation of neurologist consultation). The record must show prior therapy trials with details (agent, dose, dates, and outcome: ineffective, not tolerated, or contraindicated). Requests missing required prior therapy documentation may be denied.

Required documentation: diagnosis, neurologist note or consultation, and details of prior trials (agent, dose, start/stop dates, and reason for failure/intolerance/contraindication).
Missing or incomplete documentation of prior therapies may result in denial of the request.

Step Therapy

Prior Therapy Trials Required

Required prior therapy trials — For CIDP, a trial of both of the following must have been ineffective, not tolerated, or contraindicated: corticosteroid AND IV or SC immune globulin. For generalized myasthenia gravis (gMG), required prior trials include an acetylcholinesterase inhibitor (ineffective, not tolerated, or contraindicated) and a trial of either an oral corticosteroid or an oral non-steroidal immunosuppressant (ineffective, not tolerated, or contraindicated).

CIDP: documentation that both corticosteroid and IV/SC immune globulin were tried and failed, not tolerated, or contraindicated.
gMG: documentation of acetylcholinesterase inhibitor trial and a trial of either oral corticosteroid or oral non-steroidal immunosuppressant.

Denial Risk

Combination with Other Biologics Prohibited

Combination therapy prohibition — Use of efgartigimod alfa/hyaluronidase in combination with other biologic therapies for myasthenia gravis is prohibited and may trigger denial if combined biologic therapy is documented or intended.

For gMG: attestation that therapy will not be used in combination with other biologic therapies for myasthenia gravis.

Background

This policy addresses coverage for efgartigimod alfa/hyaluronidase (Vyvgart Hytrulo) for immune‑mediated neuromuscular disorders, specifically chronic inflammatory demyelinating polyneuropathy (CIDP) and generalized myasthenia gravis (gMG). For CIDP the policy requires a confirmed diagnosis, neurologist involvement, and prior trials of both corticosteroid and IV/SC immune globulin that were ineffective, not tolerated, or contraindicated. For gMG the policy defines candidates by neurologist involvement, confirmed diagnosis, positive anti‑acetylcholine antibody serology, MGFA Class II–IV, and an MG‑ADL total score ≥ 5, plus required prior trials of symptomatic and immunosuppressive therapies; continuation approvals require documented clinical benefit.

Definitions

MG-ADL — definition

Scale descriptionAn eight-item patient-reported scale assessing myasthenia gravis symptoms and their effects on daily activities

Item scoringEach of the 8 items is scored 0–3

Total score rangeTotal MG-ADL score ranges from 0–24

Clinically meaningful changeA two-point reduction is considered clinically meaningful