CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) — Coverage Criteria

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Covers medical benefit criteria for Vyvgart Hytrulo subcutaneous formulation for adults with generalized myasthenia gravis (AChR antibody positive) and chronic inflammatory demyelinating polyneuropathy (CIDP), including initial and continuation authorization requirements and quantity limits.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVyvgart Hytrulo (efgartigimod alfa and hyaluronidase) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2026

Last ReviewApr 1, 2026

Next Review DateN/A

Key ActionPrior authorization required through the plan's Pharmacy Drug Review with supporting medical records and neurologist involvement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase) — Coverage Criteria

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Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVyvgart Hytrulo (efgartigimod alfa and hyaluronidase) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2026

Last ReviewApr 1, 2026

Next Review DateN/A

Key ActionPrior authorization required through the plan's Pharmacy Drug Review with supporting medical records and neurologist involvement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

FDA‑approved indications covered

6 monthsAuth duration

Coverage Criteria for Vyvgart Hytrulo

Initial authorization — generalized myasthenia gravis (gMG)

Covered for gMG when ALL of the following are met:

gMG initial: 1) Documentation in medical records supporting a diagnosis of generalized myasthenia gravis (gMG).

gMG initial: 2) Positive serologic test for anti-acetylcholine receptor (AChR) antibodies documented in the record.

gMG initial: 3) Myasthenia Gravis Foundation of America (MGFA) clinical classification of class II to IVb documented.

gMG initial: 4) Baseline objective assessment of neurological weakness and fatigability documented (e.g., QMG or MG-ADL).

gMG initial: 5) Baseline MG-Activities of Daily Living (MG-ADL) total score ≥ 5 documented.>= 5

At least ONE of

a: Tried and had an inadequate response to at least ONE conventional agent used for myasthenia gravis (e.g., corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide).
b: Intolerance or hypersensitivity to ONE conventional agent used for myasthenia gravis (same agent list as above).
c: FDA‑labeled contraindication to ALL conventional agents used for myasthenia gravis (same agent list as above).
d: Member required chronic intravenous immunoglobulin (IVIG).
e: Member required chronic plasmapheresis/plasma exchange.

gMG initial: 7) Current medications assessed and any medications known to exacerbate myasthenia gravis have been discontinued OR discontinuation is not clinically appropriate.

gMG initial: 8) Member is ≥ 18 years of age.

gMG initial: 9) Prescribed by, or in consultation with, a neurologist.

gMG initial: 10) Only one formulation of efgartigimod will be used (intravenous or subcutaneous).

gMG initial: 11) Not to be used in combination with other immunomodulatory biologic therapies.

gMG initial: 12) No FDA‑labeled contraindications to the requested agent.

gMG initial: 13) Requested dose/quantity is within FDA‑labeled dosing for the indication.

Authorization of 6 months may be granted; see quantity limits.

Initial authorization — chronic inflammatory demyelinating polyneuropathy (CIDP)

Covered for CIDP when ALL of the following are met:

CIDP initial: 1) Documentation that disease course is progressive or relapsing/remitting for at least 2 months.

CIDP initial: 2) Documentation of progressive or relapsing motor‑sensory impairment of more than one limb.

CIDP initial: 3) Electrodiagnostic confirmation of demyelination meeting at least one specified criterion (e.g., prolonged distal motor latency in ≥2 motor nerves; reduced motor conduction velocity in ≥2 motor nerves; prolonged F‑wave latency in ≥2 motor nerves; absent F‑wave in ≥2 motor nerves plus another criterion; partial motor conduction block in ≥2 motor nerves or in 1 nerve plus another criterion; abnormal temporal dispersion in ≥2 motor nerves; distal CMAP duration increase in ≥1 nerve plus another criterion).

CIDP initial: 4) Baseline strength/weakness documented with an objective clinical measuring tool (e.g., INCAT, MRC, 6‑MWT, Rankin).

Reauthorization / continuation criteria

Criteria for continued therapy (reauthorization):

gMG continuation: 1) Member was previously approved for the requested drug through the plan's Pharmacy Drug Review process.

gMG continuation: 2) Continued prescribing by, or in consultation with, a neurologist.

gMG continuation: 3) Objective evidence of clinical benefit: decrease of at least 2 points from baseline in MG‑ADL total score sustained for ≥ 4 weeks (or ≥ 3‑point improvement in QMG sustained ≥ 4 weeks) AND documented improvement in muscle strength testing with fatigue maneuvers compared to baseline.>= 2‑point MG‑ADL improvement sustained >= 4 weeks

gMG continuation: 4) Member requires continuous treatment due to new or worsening disease activity after an initial beneficial response; subsequent cycles administered no sooner than 28 days from prior cycle.

All uses of Vyvgart Hytrulo outside the two FDA‑approved indications — generalized myasthenia gravis (AChR antibody positive) and chronic inflammatory demyelinating polyneuropathy (CIDP) — are considered experimental/investigational and not medically necessary.

This policy applies to the Vyvgart Hytrulo prefilled syringe formulation. It does not apply to the Vyvgart Hytrulo single‑dose vials (1,008 mg efgartigimod alfa and 11,200 units hyaluronidase per 5.6 mL) that are intended to be administered only by a healthcare professional; vial dosing differs from the prefilled syringe and those vials are governed by a separate medical benefit policy. See the dosage/administration and quantity‑limit sections for prefilled syringe specifics.

Use of Vyvgart Hytrulo for indications other than the FDA‑approved gMG (AChR antibody positive) and CIDP is not medically necessary.

Clinical Score Thresholds and Coding-related Criteria

inv-07: Baseline MG-ADL score

Required baseline MG-ADL total scoreMG-ADL total score ≥ 5 is required prior to initiation

Assessment tools for baseline weaknessBaseline neurological exam should document objective weakness/fatigability using QMG or MG-ADL (or similar)

Supporting serology for gMGDocumentation of positive anti‑AChR antibody test required

inv-08: MG-ADL response

Primary response criterion (MG-ADL)Improvement of ≥ 2 points from baseline in MG‑ADL total score, sustained for ≥ 4 weeks

Alternative objective criterion (QMG)May substitute an improvement of ≥ 3 points from baseline in QMG total score, sustained for ≥ 4 weeks

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required for initial use and reauthorization. Requests must document that the member was previously approved through the plan's Pharmacy Drug Review for continuation requests; new patients require initial evaluation review. Approval duration: up to 6 months when indication-specific criteria are met.

Applies to intravenous and subcutaneous formulations — only one formulation may be used at a time.
Prescriber: neurologist or in consultation with a neurologist.

Documentation Required

Documentation Requirements — medical records, serologic testing, baseline and objective clinical measures

Documentation must include medical records (chart notes), laboratory values, and objective clinical measures to support the diagnosis and baseline status. For gMG: include serologic testing for anti-acetylcholine receptor (AChR) antibodies, MGFA clinical classification, baseline neurological exam findings (e.g., QMG or MG-ADL), and baseline MG-ADL total score. For CIDP: include electrodiagnostic testing confirming demyelination (per listed criteria) and a baseline objective strength/functional measure (e.g., INCAT, MRC, 6-MWT, Rankin).

Background

Vyvgart Hytrulo is a subcutaneous formulation of efgartigimod alfa and hyaluronidase supplied as a single‑dose 5 mL prefilled syringe containing 1,000 mg efgartigimod alfa and 10,000 units hyaluronidase (200 mg/2,000 units per mL). It is FDA‑approved for adults with AChR antibody–positive generalized myasthenia gravis (gMG) and for chronic inflammatory demyelinating polyneuropathy (CIDP). For gMG, dosing is once‑weekly subcutaneous injections for 4 weeks per treatment cycle, with subsequent cycles administered based on clinical evaluation and in clinical trials given no sooner than 28 days from the prior cycle; CIDP dosing is once‑weekly subcutaneous injections. Quantity limits for the prefilled syringe formulation are specified (e.g., 4 syringes per 28 days, with gMG coverage requests approved for 4 syringes per 56 days).

Clinical Definitions and Response Criteria

inv-14: MG-ADL — definition and baseline requirement

DefinitionMG‑ADL = Myasthenia Gravis–Activities of Daily Living score

Baseline requirementBaseline MG‑ADL total score must be ≥ 5 prior to initiation of therapy

Use in assessmentMG‑ADL may be used as an objective baseline measure of weakness/fatigability alongside QMG

inv-15: MG-ADL response criterion

MG‑ADL improvement thresholdClinical response defined as ≥ 2‑point reduction in MG‑ADL total score from baseline sustained for ≥ 4 weeks

QMG alternativeA ≥ 3‑point reduction in QMG total score sustained for ≥ 4 weeks may be used instead, if available

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVyvgart Hytrulo (efgartigimod alfa and hyaluronidase) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2026

Last ReviewApr 1, 2026

Next Review DateN/A

Key ActionPrior authorization required through the plan's Pharmacy Drug Review with supporting medical records and neurologist involvement.

SourceLink

On This Page

One of the following

a: Tried and had an inadequate response to at least a 3‑month trial of one standard‑of‑care therapy (corticosteroids, immunoglobulins, or plasma exchange).
b: Intolerance to at least one standard‑of‑care therapy (same list as above).
c: FDA‑labeled contraindication to ALL standard‑of‑care therapies referenced above.

CIDP initial: 6) Not used as maintenance therapy in combination with immunoglobulin.

CIDP initial: 7) Member is ≥ 18 years of age; prescribed by or in consultation with a neurologist; only one formulation of efgartigimod will be used; not used with other immunomodulatory biologics; no FDA‑labeled contraindications; dose within FDA‑labeled dosing.

Authorization of 6 months may be granted.

CIDP continuation: 1) Member was previously approved for the requested drug through the plan's Pharmacy Drug Review process.

CIDP continuation: 2) Continued prescribing by, or in consultation with, a neurologist.

CIDP continuation: 3) Demonstrated clinical response to therapy based on an objective clinical measuring tool (e.g., INCAT, MRC, 6‑MWT, Rankin, Modified Rankin) documented in the record.

Authorization of 6 months may be granted.

CIDP continuation: 4) Other general continuation requirements consistent with initial therapy (age ≥18, single formulation, no concomitant biologic immunomodulators, no FDA contraindications, dose within labeled dosing).

Additional continuation requirementDocumentation of improved muscle strength with fatigue maneuvers compared to baseline required for reauthorization

Chart notes and relevant labs must be provided with the request.
Baseline objective scores (e.g., MG-ADL ≥ 5 for gMG) must be documented.

Step Therapy

Prior Therapy Requirement — failure/intolerance/contraindication to standard therapies for gMG and CIDP

For generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP), members must have tried, had inadequate response to, or been intolerant of — or have an FDA‑labeled contraindication to — standard therapies prior to approval. Specific requirements:

gMG: trial and inadequate response to at least ONE conventional agent (e.g., corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide) OR intolerance to one such agent OR FDA contraindication to all conventional agents OR chronic IVIG or chronic plasmapheresis/plasma exchange.
CIDP: trial of at least a 3-month course or intolerance to one standard of care therapy (corticosteroids, immunoglobulins, or plasma exchange) or FDA‑labeled contraindication to ALL standard therapies.
Will not be used as maintenance therapy in combination with immunoglobulin for CIDP.

Denial Risk

Denial Conditions — concurrent immunomodulatory biologics or FDA‑labeled contraindications

Denial may be issued if the member is planned to use the requested agent concomitantly with other immunomodulatory biologics or has any FDA‑labeled contraindication. Also, continuation requests without prior Pharmacy Drug Review approval for the agent will require initial evaluation and may be denied if documentation is insufficient.

Concurrent use with immunomodulatory biologic therapies (e.g., nipocalimab, rozanolixizumab, zilucoplan, eculizumab, ravulizumab, inebilizumab, etc.) is not permitted.
Ensure requested dose/quantity is within FDA‑labeled dosing for the indication.

Reauthorization evidenceReauthorization also requires documented improvement in muscle strength with fatigue maneuvers compared to baseline