CurrentAvMedPolicy Pub. 100-2

Vyvgart Hytrulo (efgartigimod alfa/hyaluronidase) for CIDP — Prior Authorization Criteria

Prior authorization and step-edit requirements for prescribing Vyvgart Hytrulo (J9334) for treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for AvMed members; applies to providers submitting medical PA requests for this drug.

Policy Summary

PayerAvMed

PolicyVyvgart Hytrulo (efgartigimod alfa/hyaluronidase) for CIDP — Prior Authorization Criteria

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionPrescriber must complete and sign the PA/step-edit request and submit required clinical documentation to obtain prior authorization for Vyvgart Hytrulo (J9334).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial authorization length

18+member age (yrs)

J9334HCPCS

1/wkquantity limit

Coverage Criteria for Vyvgart Hytrulo (CIDP)

Initial Therapy

Policy Summary

PayerAvMed

PolicyVyvgart Hytrulo (efgartigimod alfa/hyaluronidase) for CIDP — Prior Authorization Criteria

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionPrescriber must complete and sign the PA/step-edit request and submit required clinical documentation to obtain prior authorization for Vyvgart Hytrulo (J9334).

SourceLink

On This Page

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Initial Approval Criteria

Member is 18 years of age or older.
Prescribed by or in consultation with a specialist for CIDP.
Member has progressive or relapsing and remitting CIDP for > 2 months (documentation required).
Probable or Definite CIDP according to EFNS/PNS 2010.
Decreased or absent deep tendon reflexes in upper or lower limbs.
Electrodiagnostic testing indicating demyelination meeting TWO of the specified parameters (examples include: partial motor conduction block in ≥2 motor nerves or in 1 nerve plus one other demyelination criterion in ≥1 other nerve; distal CMAP duration increase in ≥1 nerve plus one other criterion; abnormal temporal dispersion in ≥2 motor nerves; reduced motor conduction velocity in ≥2 motor nerves; prolonged distal motor latency in ≥2 motor nerves; absent F wave in ≥2 motor nerves plus one other demyelination criterion; prolonged F wave latency in ≥2 motor nerves; >30% amplitude reduction of the proximal negative peak CMAP relative to distal in two nerves or in one nerve plus >1 other demyelinating parameter).
Baseline CIDP Disease Activity Status (CDAS) score ≥ 2 (submit documentation).
Baseline strength documented using an objective clinical measuring tool (e.g., INCAT, MRC).
Member has tried and failed at least a 3-month trial of immunoglobulin (IG) or plasma exchange (documentation required).
Requested medication will NOT be used as maintenance therapy in combination with immunoglobulin or intravenous efgartigimod.
All criteria lines on the PA form must be documented and met for approval; submit supporting documentation (labs, diagnostics, chart notes) for each checked item.

Authorization length: Initial coverage will be provided for 6 months and may be renewed annually thereafter.

Coding and Quantity Limits

Covered HCPCS CodesHCPCSCovered

J9334

Vyvgart ® Hytrulo (efgartigimod alfa/hyaluronidase-qvfc) (Medical)

Quantity/Unit Descriptorsmixed

1,008 mg / 11,200 units	Vyvgart Hytrulo single-dose vial — 504 billable units per vial per week
1,000 mg / 10,000 units	Vyvgart Hytrulo single-dose prefilled syringe — 500 billable units per syringe per week

inv-05: Age — >= 18 years

Minimum ageMember is 18 years of age or older

ApplicabilityRequirement applies to initial authorization and documented on PA form

Authorization lengthInitial coverage provided for 6 months (see PA form for renewal)

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior authorization required — Vyvgart Hytrulo (J9334)

Prior authorization is required for Vyvgart Hytrulo (J9334) for treatment of CIDP; the prescriber must complete and sign the medical prior authorization/step-edit request and include the required clinical documentation for approval.

Step Therapy

Prior therapy required — 3-month IG or plasma exchange trial

Member must have tried and failed at least a 3-month trial of immunoglobulin (IG) or plasma exchange; documentation of the prior trial and inadequate efficacy must be submitted.

Documentation Required

Required clinical documentation to support CIDP criteria

Submit clinical documentation supporting the CIDP diagnosis and that all clinical criteria are met (e.g., electrodiagnostic testing showing demyelination per the form, EFNS/PNS classification, clinical exam findings, baseline CDAS score, and objective strength measures).

Electrodiagnostic test results demonstrating required demyelination parameters
EFNS/PNS 2010 classification (Probable or Definite CIDP)
Baseline CDAS score and objective strength measures (e.g., INCAT, MRC)
Chart notes and lab/diagnostic reports supporting each checked criterion

Documentation Required

Administrative documentation required on PA form

Provide complete administrative information on the PA form, including prescriber signature (hand-signed; preprinted stamps not valid), full member and prescriber contact details, weight and date obtained (if applicable), dosing schedule, length of therapy, diagnosis and ICD code.

Prescriber signature (must sign and clearly print name)
Member name, AvMed ID, date of birth, office contact, phone and fax
Prescriber NPI and contact information
Weight and date weight obtained (if applicable), dosing schedule, length of therapy, diagnosis and ICD code

Denial Risk

Risk of delay or denial for incomplete/insufficient documentation

Authorization can be delayed or denied if the PA form is incomplete, incorrect, illegible, or if required supporting documentation (labs, diagnostics, chart notes) is not provided.

Background

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is an immune-mediated neuropathy characterized by progressive or relapsing symptoms of weakness and sensory dysfunction. Diagnosis and treatment decisions are supported by clinical examination and objective measures; the PA form requires documentation of baseline disease activity such as a CIDP Disease Activity Status (CDAS) score ≥ 2 and objective baseline strength assessment (e.g., INCAT or MRC). Standard treatments include immunoglobulin and plasma exchange, and the form requires evidence of a failed ≥ 3-month trial of immunoglobulin or plasma exchange before approving Vyvgart Hytrulo for CIDP.

Definitions and Clinical Scales

inv-12: EFNS/PNS classification — Probable or Definite CIDP according to EFNS/PNS 2010

Required classificationProbable or Definite CIDP according to EFNS/PNS 2010

DocumentationEFNS/PNS classification must be documented on the PA form to support this criterion

Role in criteria setOne of multiple clinical criteria that must be met for approval

inv-13: CDAS — CIDP Disease Activity Status (CDAS) score; baseline CDAS ≥ 2 required per the form

Baseline CDAS thresholdBaseline CIDP Disease Activity Status (CDAS) score ≥ 2 required (submit documentation)

PurposeQuantifies baseline disease activity to support medical necessity

DocumentationBaseline CDAS score must be provided on the PA form as supporting evidence