CurrentAvMedPolicy Pub. 100-2

Vyvgart (efgartigimod alfa) and Vyvgart Hytrulo prior authorization

Authorization form and medical necessity criteria for Vyvgart (IV) and Vyvgart Hytrulo (SC) for treatment of generalized myasthenia gravis in AvMed members; defines documentation and clinical requirements for initial and reauthorization decisions.

Policy Summary

PayerAvMed

PolicyVyvgart (efgartigimod alfa) and Vyvgart Hytrulo prior authorization

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionPrescriber must complete and sign the prior authorization form and submit required clinical documentation including diagnosis, weight, labs (anti‑AChR antibody, IgG), baseline MG‑ADL/QMG scores, and prior therapy records.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization period

6 monthsReauthorization period

50 daysMinimum interval

≥6 g/LBaseline IgG

≥5Baseline MG‑ADL

Coverage and Medical Necessity Criteria

Initial Authorization

Covered when ALL of the following are met:

Initial Authorization: Prescribing physician is a neurologist; member is ≥18 years of age; MGFA Clinical Classification II–IV with positive anti‑acetylcholine receptor (anti‑AChR) antibody (lab result must be submitted); objective signs of neurologic weakness/fatigability documented on baseline neurologic exam (e.g., QMG) with chart notes submitted; baseline MG‑ADL total score ≥ 5 (results must be submitted); baseline immunoglobulin G (IgG) ≥ 6 g/L (600 mg) (results must be submitted); member has ONE of: tried and had inadequate response to pyridostigmine OR has intolerance/hypersensitivity/contraindication to pyridostigmine (verified by chart notes or pharmacy paid claims); member has ONE of: failed >1 year of therapy with at least two immunosuppressive therapies (e.g., azathioprine, cyclosporine, mycophenolate) OR failed at least one immunosuppressive and required chronic plasmapheresis/plasma exchange (PE) or IVIG (verified by chart notes or pharmacy paid claims); member will avoid or use with caution medications known to worsen MG (e.g., aminoglycosides, fluoroquinolones, beta‑blockers, botulinum toxins, hydroxychloroquine); member does NOT have an active infection (including clinically important localized infections); requested medication will NOT be administered with live‑attenuated or live vaccines during treatment; medication will NOT be used in combination with other immunomodulatory biologic therapies (e.g., rituximab, eculizumab, ravulizumab, rozanolixizumab‑noli, zilucoplan); dosing and quantity limits follow the recommended regimen and subsequent cycles are administered based on clinical evaluation (do not initiate subsequent cycles sooner than 50 days from the start of the previous treatment cycle).

All checked items must be supported by submitted documentation (labs, diagnostics, chart notes, or pharmacy claims) or the request may be denied.

Policy Summary

PayerAvMed

PolicyVyvgart (efgartigimod alfa) and Vyvgart Hytrulo prior authorization

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

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.

Reauthorization

Covered when ALL of the following are met:

Reauthorization: Member continues to meet all initial authorization criteria; member has NOT experienced unacceptable toxicity from the drug (e.g., infections, severe hypersensitivity or infusion reactions); member meets ONE of: demonstrated improvement of ≥2 points in MG‑ADL total score from baseline sustained for ≥4 weeks (results must be submitted) OR demonstrated improvement of ≥3 points in QMG total score from baseline sustained for ≥4 weeks (results must be submitted) OR requires continuous treatment after an initial beneficial response due to new or worsening disease activity; minimum of 50 days has elapsed from the start of the previous treatment cycle before administering the next cycle.

Objective results (MG‑ADL or QMG) must be submitted to document clinical improvement.

Billing Codes and Key Clinical Thresholds

Covered HCPCS CodesHCPCSCovered

J9332	Vyvgart (efgartigimod alfa-fcab) IV
J9334	Vyvgart Hytrulo (efgartigimod alfa/hyaluronidase-qvfc) SC

Baseline IgG requirement

Required baseline IgG>= 6 g/L (600 mg) (documented lab result required)

Evidence requiredSubmit laboratory report showing IgG >= 6 g/L

TimingBaseline IgG must be documented prior to initiation of therapy

Baseline MG-ADL requirement

Required baseline MG-ADL scoreMG-ADL total score >= 5 (results must be submitted)

Reauthorization response thresholdImprovement of >= 2 points in MG-ADL total score from baseline sustained for >= 4 weeks (results must be submitted)

DocumentationBaseline and follow-up MG-ADL scores must be included in chart notes submitted for authorization/reauthorization

Minimum interval between treatment cycles

Minimum interval between treatment cycles>= 50 days from start of previous treatment cycle (safety of initiating sooner not established)

Cycle timing guidanceSubsequent treatment cycles should be administered based on clinical evaluation; do not initiate sooner than 50 days unless supported by documentation

Related dosing noteRecommended regimen is 4 weekly doses per 50-day (8-week) cycle for IV and SC formulations

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vyvgart (efgartigimod alfa-fcab) IV (J9332) and Vyvgart Hytrulo (efgartigimod alfa/hyaluronidase-qvfc) SC (J9334). The prescribing physician must sign and clearly print their name on the request (preprinted stamps are not valid). Incomplete, incorrect, or illegible information may delay authorization.

Drugs: Vyvgart (J9332) and Vyvgart Hytrulo (J9334)
Prescriber signature required (hand-signed; preprinted stamps not valid)
Fax completed request to 1-877-535-1391

Step Therapy

Prior Medication Trials Required

Prior medication trials or documented contraindications/intolerances are required before approval. Provide chart notes or pharmacy paid claims to verify prior therapies and outcomes.

Member has tried and had an inadequate response to pyridostigmine, OR has intolerance/hypersensitivity/contraindication to pyridostigmine
AND ONE of the following:
• Failed >1 year of therapy with at least 2 immunosuppressive therapies (e.g., azathioprine, cyclosporine, mycophenolate), OR
• Failed at least 1 immunosuppressive therapy and required chronic plasmapheresis/plasma exchange (PE) or intravenous immunoglobulin (IVIG)

Documentation Required

Required Documentation

Submit the following documentation with the prior authorization request. Missing required documentation may result in denial or processing delays.

Diagnosis and ICD code
Weight and date weight obtained (if applicable)
Baseline neurologic exam notes documenting objective signs of weakness/fatigability (e.g., QMG score)
Baseline MG-Activities of Daily Living (MG-ADL) total score ≥ 5 (submit results)
Positive serologic test for anti-acetylcholine receptor (AchR) antibodies (submit lab report)
Baseline immunoglobulin G (IgG) level ≥ 6 g/L (600 mg) (submit lab report)
Evidence of prior therapies (chart notes or pharmacy paid claims) to verify pyridostigmine and immunosuppressive therapy history
Prescribing physician specialty (must be a neurologist) and prescriber signature

Denial Risk

Incomplete Submission Risks

Incomplete, incorrect, or illegible submissions, or missing required clinical information, may lead to denial or delays in processing. Ensure all requested labs, scores, and prior therapy verification are included.

Illegible or unsigned prescriber form risks processing delays or denial
Missing lab results (AchR antibody, IgG) or missing baseline scores (QMG, MG-ADL) may result in denial
Lack of verification of prior medications or treatments (chart notes or pharmacy claims) may result in denial

Denial Risk

Clinical Exclusion Triggers

Therapy will NOT be approved if any exclusion criteria below are met. Review recent treatments and infection status prior to initiation.

MGFA Class I disease or myasthenic crisis (MGFA Class V) at initiation of treatment
Use of rituximab within 6 months prior to proposed treatment start
Use of IVIG or plasmapheresis/plasma exchange (PE) within 4 weeks prior to proposed treatment start
Any active or clinically significant infection that has not been treated

OpenPayer

Vyvgart (efgartigimod alfa) and Vyvgart Hytrulo prior authorization

Coverage and Medical Necessity Criteria

Billing Codes and Key Clinical Thresholds

Prior Authorization, Documentation, and Provider Responsibilities

Background and Scope

Clinical Definitions and Assessment Tools