CurrentCignaPolicy N/A

Vyvgart (efgartigimod alfa-fcab) IV prior authorization for generalized myasthenia gravis

Prior authorization form and clinical criteria for prescribing Vyvgart IV (efgartigimod alfa-fcab) for generalized myasthenia gravis (gMG); intended for prescribers and facilities submitting requests to Cigna for drug coverage and administration.

Policy Summary

PayerCigna

PolicyVyvgart (efgartigimod alfa-fcab) IV prior authorization for generalized myasthenia gravis

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionFax the completed prior authorization form to (855) 840-1678 or submit online and attach required documentation including anti-AChR antibody results, MGFA class, MG-ADL score, and prescriber signature/date.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Vyvgart IVMedication addressed by this form

5 business daysStandard response time for prescription drug coverage requests

855-840-1678Primary fax for completed form

Vyvgart (efgartigimod alfa-fcab) IV — Coverage Criteria

General requirements for Vyvgart IV for gMG

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ALL of the following

Diagnosis of generalized myasthenia gravis (gMG) OR other specified diagnosis if provided and documented
Form includes checkbox for 'other' diagnoses but additional documentation required
If patient is not currently receiving Vyvgart, documentation of confirmed anti-acetylcholine receptor (AChR) antibody positive gMG must be provided
Medical documentation (chart notes, lab results, etc.) must be attached
If patient is not currently receiving Vyvgart, MGFA classification II to IV
Checkbox on form requires confirmation
If patient is not currently receiving Vyvgart, MG-ADL score of 5 or higher
Checkbox on form requires confirmation
If patient is not currently receiving Vyvgart, prior trial of pyridostigmine (received or currently receiving) OR documentation of inadequate efficacy, contraindication, or significant intolerance to pyridostigmine
Form asks whether pyridostigmine was received and if not, whether there was intolerance/contraindication
Physician attestation that information is true and accurate and prescriber signature/date on form
Required attestation field on form
Prescribing clinician is a neurologist or consult with a neurologist
Form asks if medication is prescribed by or in consultation with a neurologist

Continuation therapy

If patient is currently receiving Vyvgart IV (or Vyvgart Hytrulo), ALL of the following apply:

ALL of the following

Patient is currently receiving Vyvgart IV (or Vyvgart Hytrulo)
Checkbox to indicate current therapy
Prescriber attests the patient is continuing to derive clinical benefit from Vyvgart (examples include reduced exacerbations; improvements in speech, swallowing, mobility, respiratory function)
Form requires confirmation of derived benefit

Concomitant therapy exclusions

Provider must confirm the medication will not be used concurrently with certain agents:

ALL of the following

Vyvgart will NOT be used with another neonatal Fc receptor (FcRn) blocker (examples listed: nipocalimab, rozanolixizumab, Vyvgart Hytrulo)
Form asks Yes/No if used with another FcRn blocker
Vyvgart will NOT be used with a complement inhibitor (examples listed: eculizumab, ravulizumab, zilucoplan)
Form asks Yes/No if used with a complement inhibitor
Vyvgart will NOT be used with a rituximab product
Form asks Yes/No if used with rituximab

Site of care and administration

Information requested to support appropriate site of infusion:

ALL of the following

Indicate where medication will be obtained (Accredo specialty pharmacy preferred, prescriber office stock, retail pharmacy, home health/home infusion vendor, other)
Accredo is designated Cigna's nationally preferred specialty pharmacy
Indicate facility/doctor dispensing and administering medication including state, tax ID, address
Form captures facility details for billing
Indicate where drug will be administered (patient's home, physician's office, hospital outpatient, other)
Form asks if patient is candidate for home infusion or if physician has in-office infusion site
Per some Cigna plans, infusion must occur in the least intensive, medically appropriate setting; consider redirection to alternate setting with Specialty Care Options Case Manager
Form asks whether patient is a candidate for re-direction

What Providers Must Do

Prior Authorization

Submit completed prior authorization form

Fax the completed prior authorization form to (855) 840-1678 or submit online via the provided portal; if the request is urgent, call to expedite. Include all required patient identifiers and the prescriber signature and date on the form.

Fax completed form to: (855) 840-1678
If this is an URGENT request, please call (800) 882-4462
Ensure all asterisked patient ID fields are completed and prescriber signature/date are provided

Documentation Required

Attach supporting medical documentation

For initiation requests (patient not currently receiving Vyvgart), attach medical documentation confirming anti‑AChR antibody positivity and records of prior therapies or reasons for not using them; include the patient's MGFA class and MG‑ADL score.

Attach documentation that the patient has confirmed anti‑acetylcholine receptor (AChR) antibody positive gMG
Document prior trial of pyridostigmine or provide evidence of inadequate efficacy, contraindication, or significant intolerance
Include Myasthenia Gravis Foundation of America (MGFA) class II–IV and MG‑ADL score (≥5) when patient is not currently receiving Vyvgart

Documentation Required

Attest clinical benefit for continuation requests

For continuation requests (patient currently receiving Vyvgart), the prescriber must attest that the patient continues to derive clinical benefit; examples of benefit are listed on the form and should be referenced in the attestation.

Prescriber attestation that patient is continuing to derive benefit from Vyvgart
Examples of derived benefit include reductions in exacerbations and improvements in speech, swallowing, mobility, and respiratory function

Prior Authorization

Specify site of drug procurement and administration

Indicate where the medication will be obtained and where it will be administered, and provide facility/doctor dispensing and administration details including Tax ID and address for billing.

Specify source: Accredo Specialty Pharmacy, prescriber's office stock (billing on a medical claim), retail pharmacy, home health/home infusion vendor, or other
Indicate administration site: patient's home, physician's office, hospital outpatient, or other
Provide facility name, state, Tax ID number, and address for billing purposes

Requested Codes and Medication

ICD-10 diagnosis codes requested on formICD-10

G70.00	Myasthenia gravis without (acute) exacerbation (example code — form provides ICD-10 field but does not list codes)
G70.01	Myasthenia gravis with (acute) exacerbation (example code)

MedicationNDC|HCPCSCovered

Vyvgart 400 mg/20 mL (20 mg/mL) vial

efgartigimod alfa-fcab intravenous vial — medication requested on form; specific NDC/HCPCS not provided on form

Clinical and Administrative Background

Vyvgart (efgartigimod alfa-fcab) is an intravenous neonatal Fc receptor (FcRn) blocker indicated for generalized myasthenia gravis (gMG). The prior authorization form collects key clinical information to support coverage decisions, including documentation of serologic diagnosis (confirmation of anti-acetylcholine receptor [AChR] antibody positive gMG when the patient is not already on Vyvgart), measures of disease severity (Myasthenia Gravis Foundation of America MGFA class II–IV and a Myasthenia Gravis Activities of Daily Living MG-ADL score ≥ 5 for initiation), and treatment history (whether the patient has received or is currently receiving pyridostigmine or has documented inadequate efficacy, contraindication, or intolerance). The form also captures whether the patient is currently receiving Vyvgart and, for continuation requests, requires a prescriber attestation that the patient is continuing to derive clinical benefit (examples include reductions in exacerbations and improvements in speech, swallowing, mobility, or respiratory function).

The form further gathers administrative and logistic data relevant to coverage and billing: where the medication will be obtained (with Accredo Specialty Pharmacy noted as Cigna’s nationally preferred specialty pharmacy), the site of administration (home, physician office, hospital outpatient, etc.), and facility/doctor dispensing details (including Tax ID and address). A signed prescriber attestation and supporting medical documentation (chart notes, lab results, test results) must be attached when required to verify diagnosis and prior therapies.

Defined Terms on the Form

Definitions

MG-ADLMyasthenia Gravis Activities of Daily Living score — functional assessment used to quantify symptom burden; form requires score >=5 for initiation if not already receiving therapy.

MGFAMyasthenia Gravis Foundation of America clinical classification — form requires class II to IV for initiation if not already receiving therapy.

Anti-acetylcholine receptor (AChR) antibody positiveSerologic confirmation of AChR autoantibodies supporting diagnosis of generalized myasthenia gravis; documentation must be attached if patient is not currently receiving Vyvgart.

Scope and Contact

This prior authorization form and accompanying clinical criteria apply to requests for coverage of Vyvgart IV (efgartigimod alfa-fcab) for generalized myasthenia gravis (gMG). It is intended for prescribers and facilities submitting authorization requests to Cigna and outlines the required clinical information (diagnosis confirmation, MGFA class, MG-ADL score, pyridostigmine history), site-of-care and procurement details (Accredo preferred, prescriber office stock, home infusion, etc.), and the administrative steps to submit a complete request (fax to (855) 840-1678 or submit online). The form also documents continuation requirements and contraindicated concurrent therapies to ensure requests meet Cigna’s coverage criteria.

Quick stats

Medication addressed by this formVyvgart IV

Standard response time for prescription drug coverage requests5 business days

Primary fax for completed formFax (855) 840-1678

Policy Summary

PayerCigna

PolicyVyvgart (efgartigimod alfa-fcab) IV prior authorization for generalized myasthenia gravis

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

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