CurrentMass General Brigham Health PlanPolicy N/A

Vyvgart (efgartigimod) and Vyvgart Hytrulo — Prior Authorization (pharmacy benefit) coverage criteria

Prior authorization policy for Vyvgart and Vyvgart Hytrulo under the pharmacy benefit for Commercial/Exchange members; defines clinical criteria for initial and reauthorization for gMG and CIDP.

Policy Summary

PayerMass General Brigham Health Plan

PolicyVyvgart (efgartigimod) and Vyvgart Hytrulo — Prior Authorization (pharmacy benefit) coverage criteria

Policy CodePolicy N/A

Change TypeMaterial operational and coverage revisions

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization through the pharmacy benefit with baseline and follow-up documentation (e.g., MG-ADL/QMG for gMG; electrodiagnostic confirmation and objective measures for CIDP).

SourceLink

POLICY UPDATE CHANGES

Policy updated to indicate it no longer applies to the medical benefit and is pharmacy benefit only.

Approval criteria for CIDP specific to Vyvgart Hytrulo were added.

Removed age and specialist prescriber requirements from gMG approval criteria in prior update.

6 monthsapproval length

≥5MG-ADL threshold

AChR+required serostatus

IVIG/SCIG failure

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Coverage Criteria for Vyvgart and Vyvgart Hytrulo

Generalized Myasthenia Gravis - Initial Therapy

Covered when ALL of the following are met

gMG Initial: Member has a diagnosis of generalized myasthenia gravis (gMG) with BOTH: a) Myasthenia Gravis Foundation of America (MGFA) clinical classification II to IV; AND b) MG-Activities of Daily Living (MG-ADL) total score of ≥ 5.MG-ADL ≥ 5

gMG Initial: Anti-acetylcholine receptor (AChR) antibody positive.

gMG Initial: Member is currently on a stable dose of at least ONE baseline therapy: a) acetylcholinesterase inhibitor (e.g., pyridostigmine); b) corticosteroid; OR c) nonsteroidal immunosuppressive therapy (e.g., azathioprine, mycophenolate mofetil).

Chronic Inflammatory Demyelinating Polyneuropathy - Initial Therapy

Covered when ALL of the following are met

CIDP Initial: Member has a diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) confirmed by electrodiagnostic tests (e.g., electromyography, nerve conduction studies).

CIDP Initial: Member has had an inadequate response, adverse reaction, or contraindication to immunoglobulin therapy (IVIG or SCIG).

CIDP Initial: Product requested must be Vyvgart Hytrulo (approvals for CIDP are limited to Vyvgart Hytrulo only).

See policy limitation: CIDP approvals limited to Vyvgart Hytrulo.

Generalized Myasthenia Gravis - Reauthorization

Reauthorization approved when ALL of the following are met

gMG Reauth: Provider submits documentation of a positive response to therapy, for example improvement in MG-ADL score or changes compared to baseline in Quantitative Myasthenia Gravis (QMG) total score.

Initial and reauthorization approvals are granted for 6 months per policy limitations.

Chronic Inflammatory Demyelinating Polyneuropathy - Reauthorization

Reauthorization approved when ALL of the following are met

CIDP Reauth: Provider submits documentation of clinical improvement in neurologic symptoms or stabilization of disease using objective measures (e.g., nerve conduction studies, INCAT, MRC sum score, grip strength).

Initial and reauthorization approvals are granted for 6 months per policy limitations. CIDP reauthorizations are limited to Vyvgart Hytrulo.

Approvals for chronic inflammatory demyelinating polyneuropathy (CIDP) under this policy are limited to the Vyvgart Hytrulo formulation only.

Key Coding and Clinical Thresholds

MG-ADL threshold (inv-06)

Required MG-ADL thresholdMG-ADL total score ≥ 5

UseBaseline MG-ADL required for initial gMG coverage determination

ScopeApplies to Vyvgart and Vyvgart Hytrulo for generalized myasthenia gravis

MG-ADL score (definition) (inv-12)

DefinitionMG-Activities of Daily Living (MG-ADL) total score

Role in policyRequired baseline score used to determine eligibility for initial therapy (see required threshold ≥ 5)

Documenting

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required through the pharmacy benefit for Commercial/Exchange members. Requests must be submitted to the plan's pharmacy prior authorization contact; this medication is specialty and must be filled at a contracted specialty pharmacy. Initial approvals follow the policy's clinical criteria for indication (gMG or CIDP) and operational rules for members new to the plan (see triggers for denial).

Pharmacy benefit prior authorization only for Commercial/Exchange members
Specialty product — must be dispensed at contracted specialty pharmacy
Pharmacy PA phone: 800-711-4555; Fax: 844-403-1029

Step Therapy

There is no step therapy program applicable to Vyvgart or Vyvgart Hytrulo under this policy.

Background and Scope

Vyvgart (efgartigimod) and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) are targeted therapies for antibody‑mediated neuromuscular disorders. Vyvgart is indicated for adults with acetylcholine receptor (AChR) antibody–positive generalized myasthenia gravis (gMG). Vyvgart Hytrulo carries the additional indication for adults with chronic inflammatory demyelinating polyneuropathy (CIDP). Clinical monitoring uses disease‑specific validated measures (for gMG: MG‑ADL, QMG; for CIDP: nerve conduction studies, INCAT, MRC sum score, grip strength).

Documentation Required

Required Documentation

For initial and reauthorization requests the provider must submit baseline and follow‑up documentation supporting diagnosis and clinical response. For gMG include MG-ADL and/or QMG scores and documentation of MGFA class and AChR antibody status, plus current stable background therapy. For CIDP include diagnostic electrodiagnostic testing, documentation of prior inadequate response or intolerance to IVIG/SCIG, and objective measures of neurologic status for reauthorization (e.g., INCAT, MRC sum score, grip strength, or nerve conduction studies).

gMG baseline: MG-ADL score (≥5) and MGFA clinical classification II–IV; AChR antibody positive; current stable dose of at least one background therapy (e.g., pyridostigmine, corticosteroid, or NSIST)
gMG follow-up: documented clinical improvement (change in MG-ADL and/or QMG vs baseline) for reauthorization
CIDP baseline: confirmatory electrodiagnostic testing and prior trial of IVIG or SCIG with inadequate response, adverse reaction, or contraindication
CIDP follow-up: objective evidence of clinical improvement or disease stabilization (e.g., INCAT, MRC sum score, grip strength, or repeat nerve conduction studies)