Neighborhood Health Plan RI Vyvgart Coverage Update

Coverage Criteria

Initial Therapy (gMG)

Covered when ALL of the following universal criteria are met plus the gMG-specific criteria listed below:

Universal requirements: Patient is ≥18 years of age; AND only one formulation of efgartigimod will be used (intravenous or subcutaneous); AND will not be administered with live-attenuated or live vaccines during treatment; AND patient does not have an active infection, including clinically important localized infections; AND patient does not have a deficiency of immunoglobulin G (IgG) necessitating supplementation; AND MMP members who received this medication within the past 365 days are exempt from step therapy requirements.

gMG-specific criteria: Submission of medical records to support diagnosis of generalized myasthenia gravis (gMG); AND prescribed by or in consultation with a neurologist; AND positive serologic test for anti-acetylcholine receptor (AChR) antibodies; AND MGFA Clinical Classification II–IV; AND baseline objective neurological weakness/fatigability assessment documented (e.g., QMG or MG-ADL); AND baseline MG-ADL total score ≥5; AND inadequate response after a minimum 6-month trial of concurrent use of two or more immunosuppressive therapies OR required at least one acute or chronic plasmapheresis/plasma exchange (PE) or IVIG in addition to immunosuppressant therapy; AND will not be used in combination with other immunomodulatory biologic therapies; AND patient will avoid or use with caution medications known to worsen MG; AND for Medicaid members requesting IV doses >800 mg–1200 mg (weekly dose requiring 3 vials), documentation that patient is unable to tolerate Vyvgart Hytrulo and medical rationale provided.

Initial Therapy (CIDP)

Initial Criteria — CIDP requests are covered only for the subcutaneous formulation (Vyvgart Hytrulo) when ALL of the following are met:

CIDP-specific criteria: Request is for Vyvgart Hytrulo; AND disease course is progressive or relapsing–remitting for >2 months; AND decreased or absent deep tendon reflexes in upper or lower limbs; AND electrodiagnostic testing demonstrating demyelination meeting one of the listed criteria (e.g., partial motor conduction block in ≥2 motor nerves or in 1 nerve plus another demyelination criterion in ≥1 other nerve; distal CMAP duration increase in ≥1 nerve plus another demyelination criterion in ≥1 other nerve; 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 another demyelination criterion in ≥1 other nerve; or prolonged F wave latency in ≥2 motor nerves); AND baseline CIDP Disease Activity Status (CDAS) score ≥2; AND baseline strength/weakness documented with an objective tool (e.g., INCAT, MRC, 6‑MWT, Rankin); AND failed ≥3‑month trial of immunoglobulin (IG) or plasma exchange; AND will not be used as maintenance therapy in combination with immunoglobulin or Vyvgart IV.

Electrodiagnostic options are multiple alternative criteria listed in policy.

Continuation Therapy

Continuation of therapy is covered when ALL relevant continuation criteria are met:

Universal continuation: Patient continues to meet the universal and indication-specific initial criteria; AND absence of unacceptable toxicity from the drug (examples include infection, severe hypersensitivity, severe infusion-related reactions, etc.).

gMG continuation: Patient has had an improvement of ≥2 points from baseline in MG-ADL total score sustained for at least 4 weeks OR a ≥3‑point improvement in QMG total score sustained for at least 4 weeks; AND improvement in muscle strength with fatigue maneuvers on neurologic exam compared to baseline; AND patient requires continuous treatment after an initial beneficial response due to new or worsening disease activity (minimum of 50 days must have elapsed from the start of the previous treatment cycle).Minimum 50 days between cycles

CIDP continuation: Patient has demonstrated a clinical response to therapy based on an objective clinical measuring tool (e.g., INCAT, MRC muscle strength, 6‑MWT, Rankin/Modified Rankin).

General medical necessity

Covered when requests demonstrate consistency with FDA-approved labeling and relevant clinical literature, and meet the plan's criteria as adopted by the P&T Committee:

General coverage conditions: Request demonstrates an indication consistent with FDA-approved labeling or supported clinical literature and is for a diagnosis listed in Appendix 1; AND prescriber provides supporting clinical information for individual consideration.

Neighborhood will give individual consideration to each request based on information submitted and available to the plan.

Therapies used at a dose or for a condition other than those recognized as medically accepted indications in standard reference compendia (e.g., AHFS-DI, Micromedex DrugDex, Clinical Pharmacology, Lexi-Drugs) or supported by peer-reviewed literature are considered investigational and are not covered by the plan.

Vyvgart and Vyvgart Hytrulo will not be used in combination with other immunomodulatory biologic therapies. Examples listed in the policy include Rituxan (rituximab), Soliris (eculizumab), Ultomiris (ravulizumab), Empaveli/Syfovre (pegcetacoplan), Enspryng (satralizumab), Uplizna (inebilizumab), Rystiggo (rozanolixizumab), Zilbrysq (zilucoplan), and similar agents.

Medicare National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) take precedence for Medicare members. Where applicable, compliance with NCD/LCD/Local Coverage Articles (LCAs) is required; Neighborhood’s coverage criteria for INTEGRITY (Medicare‑Medicaid Plan) members apply only in the absence of an applicable NCD or LCD.

The plan does not provide coverage for use of Vyvgart or Vyvgart Hytrulo for investigational purposes. Uses that are outside recognized indications, doses, or conditions in standard compendia or lacking adequate peer‑reviewed evidence are considered investigational and will be denied.

Requests that are inconsistent with FDA‑approved labeling, relevant clinical literature, or the plan’s adopted clinical coverage criteria may be determined not medically necessary. The plan will review prescriber‑submitted information and available evidence and may deny coverage when the requested use is not supported by labeling, accepted literature, or the plan’s criteria.

Coding

Applicable HCPCS/CPT CodesHCPCS/CPT

J9332	Injection, efgartigimod alfa-fcab, 2mg
J9334

NDC CodesNDC

73475-3041-xx	Vyvgart 400 mg/20 mL single-dose vial (NDC)
73475-3102-xx	Vyvgart Hytrulo 1,008 mg + 11,200 units hyaluronidase per 5.6 mL single-dose vial (NDC)

Covered Diagnosis CodesICD-10Covered

G70.0	Myasthenia gravis.
G70.00	Myasthenia gravis without (acute) exacerbation.
G70.01	Myasthenia gravis with (acute) exacerbation.
G61.81	Chronic inflammatory demyelinating polyneuritis.
G61.89	Other inflammatory polyneuropathies.
G62.89	Other specified polyneuropathies

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvtc). Requests will be reviewed prospectively via the prior authorization process and evaluated against the plan's clinical criteria and FDA labeling. Use outside of these guidelines may result in non-payment unless approved through an exception process.

Prior authorization required for both Vyvgart and Vyvgart Hytrulo
Prospective review — submit prior to administration
Exceptions may be granted through the plan's exception process

Prior Authorization

Coverage and Prior Authorization

Coverage of Vyvgart and Vyvgart Hytrulo is subject to the clinical criteria established by Neighborhood Health Plan of Rhode Island and will be assessed during prior authorization. Requests will be evaluated for consistency with FDA-approved labeling and relevant clinical literature. Neighborhood may give individual consideration to requests based on prescriber-submitted information and other information available to the plan.

Prior authorization determinations made against plan clinical criteria and FDA labeling

Definitions

inv-23: gMG — definition and measurement (MG-ADL) for generalized myasthenia gravis

DefinitionGeneralized myasthenia gravis (gMG): autoimmune disease with pathogenic anti-acetylcholine receptor (AChR) antibodies causing muscle weakness; therapy reduces IgG including pathogenic AChR antibodies.

Measurement toolMyasthenia Gravis–Activities of Daily Living (MG-ADL) total score used to assess baseline disease impact and response to therapy.

Baseline threshold for treatmentBaseline MG-ADL total score ≥5 is required for initial coverage consideration.

Other objective assessmentsQuantitative Myasthenia Gravis (QMG) score may be used for baseline weakness assessment and response evaluation (continuation criteria reference).

Age requirementPatient must be ≥18 years of age for therapy eligibility.

Background

Efgartigimod is an Fc‑fragment‑containing monoclonal antibody fragment that reduces circulating total IgG, including pathogenic anti‑acetylcholine receptor (anti‑AChR) antibodies implicated in generalized myasthenia gravis (gMG). Vyvgart (intravenous efgartigimod alfa‑fcab) is FDA‑indicated for the treatment of adults with gMG who are anti‑AChR antibody positive. The subcutaneous formulation, Vyvgart Hytrulo (efgartigimod alfa with human hyaluronidase), demonstrated noninferiority to the IV formulation in trials and has been studied in chronic inflammatory demyelinating polyneuropathy (CIDP), showing evidence of prolonged time to clinical deterioration. Neighborhood adopted coverage criteria to align use of these formulations with FDA labeling and relevant clinical literature based on P&T Committee review.

OpenPayer

Vyvgart (efgartigimod) and Vyvgart Hytrulo (efgartigimod + hyaluronidase) — Intravenous and Subcutaneous

Coverage Criteria

Coding

Provider Actions & Requirements

Definitions

Background