CurrentAetnaPolicy N/A

Vyvgart / Vyvgart Hytrulo medication precertification

Precertification request form and required clinical documentation for initiation or continuation of Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for Aetna members.

Policy Summary

PayerAetna

PolicyVyvgart / Vyvgart Hytrulo medication precertification

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and submit the precertification form with all required clinical documentation (antibody status, MGFA class, MG-ADL, prior/concomitant therapies, and response/toxicity for continuation).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 pageform length

Patient, Prescriber, Product, Diagnosis, Clinicalsections required

Aetna precert phonecontact

Coverage Criteria for Vyvgart and Vyvgart Hytrulo

Initial Therapy

Initiation Requests (covered when ALL required documentation provided):

Initiation criteria: Requested drug is being used to treat generalized myasthenia gravis (gMG) AND patient anti-acetylcholine receptor (AchR) antibody status indicatedAchR antibody: yes/no documented

Form requires checkbox for AchR antibody positive

Severity and symptom burden: MGFA clinical classification indicated AND MG-ADL score provided with documentation whether at least 50% of MG-ADL is due to non-ocular symptomsMG-ADL 50% non-ocular documented

Form requests MGFA class and MG-ADL detail

Prior/concomitant therapy:

Policy Summary

PayerAetna

PolicyVyvgart / Vyvgart Hytrulo medication precertification

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Continuation Therapy

Continuation Requests (covered when ALL required documentation provided):

Effectiveness: Evidence of positive response to therapy documented (e.g., improvement in MG-ADL score or change in QMG total score compared to baseline)response documented

Form asks whether positive response observed

Safety/Disease progression: No evidence of unacceptable toxicity or disease progression while on the current regimen documentedtoxicity/progression status documented

Form includes checkbox for toxicity or progression

Provider Actions and Submission Requirements

Prior Authorization

Precertification required

Precertification is required for initiation or continuation of Vyvgart or Vyvgart Hytrulo. Complete all form sections for product, dose/frequency, diagnosis, and clinical information; include start date or date of last treatment for continuation requests.

Complete and legible patient demographics, insurance, prescriber, and dispensing/provider information
Specify product requested (Vyvgart or Vyvgart Hytrulo), dose, and frequency
Provide primary and any secondary ICD-10 diagnosis codes
Include start of treatment date for new therapy or date of last treatment for continuation

Documentation Required

Prior/concomitant therapy documentation

Document prior or concomitant therapies and stability of dosing where applicable. For initiation requests, indicate whether the patient has been on a stable dose of at least one of the following therapies: an acetylcholinesterase inhibitor (e.g., pyridostigmine), systemic corticosteroids (at least 3 months of treatment), or a nonsteroidal immunosuppressive therapy (NSIST) (at least 6 months of treatment) (e.g., azathioprine, mycophenolate mofetil).

Check and document Yes/No for stable dose of AChE inhibitor, steroids (≥3 months), or NSIST (≥6 months) as applicable
For continuation requests, document response to therapy (e.g., improvement in MG-ADL or QMG scores) or evidence of unacceptable toxicity/disease progression

Documentation Required

Required documentation

All fields on the precertification form must be completed and legible. Incomplete or missing required documentation may prevent precertification review and the plan may request additional information or clarification.

Patient information: name, DOB, contact, weight/height, allergies
Prescriber information: name, credentials, address, phone, fax, NPI, state license, specialty
Product request and dosing: selected product, dose, frequency
Clinical information: MGFA classification, MG-ADL score details, antibody status, prior/concomitant therapy stability
Signature and date on acknowledgement section

Denial Risk

Incomplete submission risk

Incomplete or illegible fields may prevent precertification review. The plan may request additional information or clarification if needed to evaluate requests.

Ensure legible completion of all fields to avoid delays
Aetna may request supplemental clinical records or clarification
Aetna Precertification Notification: Phone 1-866-752-7021 (TTY: 711); Fax 1-888-267-3277

Scales and Clinical Classifications

MG-ADL score

DefinitionMyasthenia Gravis–Specific Activities of Daily Living (MG-ADL) scale as requested on the form

Threshold requirementForm asks whether the MG-ADL score is at least 50% due to non-ocular symptoms

Documentation expectedProvide the MG-ADL total score and indicate with checkbox whether ≥50% of the score is attributable to non-ocular symptoms (Yes/No)

Use caseRequired for initiation precertification to document symptom burden and non-ocular involvement

MGFA clinical classification

DefinitionMyasthenia Gravis Foundation of America (MGFA) clinical classification as listed on the form

CategoriesClass I, Class II, Class III, Class IV, Class V (also option: Unknown)

PurposeUsed on the precertification form to indicate disease severity for initiation requests

Documentation expectedSelect the appropriate MGFA class on the form to support initiation request evaluation

Background

Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) are therapies used for generalized myasthenia gravis (gMG). The precertification form requires documentation of the patient’s anti-acetylcholine receptor (AchR) antibody status, the patient’s MGFA clinical classification (Class I–V or Unknown), the MG-ADL score and whether at least 50% of the MG-ADL score is due to non-ocular symptoms, and whether the patient is on a stable dose of at least one conventional therapy (acetylcholinesterase inhibitor, steroids for ≥3 months, or nonsteroidal immunosuppressive therapy for ≥6 months).

Primary ICD Code	Primary diagnosis ICD code for the indication (to be provided)
Secondary ICD Code	Secondary diagnosis ICD code (optional)
Other ICD Code	Additional diagnosis ICD code (optional)

OpenPayer

Vyvgart / Vyvgart Hytrulo medication precertification

Coverage Criteria for Vyvgart and Vyvgart Hytrulo

Coding (Provider-Specified)

Provider Actions and Submission Requirements

Scales and Clinical Classifications

Background