Currentculinary health fundPolicy N/A

Pdf Neurology Vyvgart Hytrulo Um Medical De Identified_Pdf

Defines prior authorization, clinical criteria, dosing, approvals, and non-recommended concomitant uses for Vyvgart Hytrulo for CIDP and anti-AChR antibody-positive generalized myasthenia gravis in adults. Specifies prescriber specialty requirements, approval durations, and restrictions on concomitant therapies.

Policy Summary

Payerculinary health fund

PolicyPdf Neurology Vyvgart Hytrulo Um Medical De Identified_Pdf

Policy CodePolicy N/A

Change TypeMultiple material updates (2024–2026)

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization is recommended; submit documentation of diagnostic support and prior therapies and ensure the medication is prescribed by or in consultation with a neurologist.

SourceLink

POLICY UPDATE CHANGES

CIDP condition and criteria for approval were added to the policy (02/28/2024).

For patients currently receiving Vyvgart Hytrulo for CIDP, requirement that patient is ≥ 18 years of age was added (06/04/2025).

Removed the requirement that treatment cycles are no more frequent than every 50 days for gMG (06/11/2025).

Conditions Not Recommended: Concomitant use list revised to include Uplizna (inebilizumab) (11/05/2025).

Selected revision entries through 02/18/2026 recorded (last review date 02/18/2026).

2Covered Indications

18Minimum age (years)

3m / 6m / 1yApproval durations (CIDP / gMG / continuation)

Coverage Summary

Vyvgart Hytrulo is a subcutaneous formulation of efgartigimod alfa with hyaluronidase indicated for treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) and for adults with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis (gMG). It is available in two SC presentations and is covered with criteria under prior authorization when the specific diagnostic, prior-therapy, prescriber, and dosing criteria are met.

Key policy facts and thresholds

Covered Indications2 (CIDP; anti‑AChR antibody‑positive gMG)

Minimum age18 years

MG-ADL threshold>= 5

Approval duration — CIDP initial3 months

Approval duration — gMG initial6 months

Approval duration — continuation1 year

Medical Necessity Criteria (by indication and dosing)

Dosing - CIDP

Approve ONE of the following formulations:

ANY of the following

One single-dose vial (1,008 mg efgartigimod alfa and 11,200 units hyaluronidase) administered as a subcutaneous injection once weekly
Vial formulation (CIDP dosing)
One single-dose prefilled syringe (1,000 mg efgartigimod and 10,000 units hyaluronidase) administered as a subcutaneous injection once weekly
Prefilled syringe formulation (CIDP dosing)

Conditions Not Recommended for Approval

Coverage is not recommended in the following situations:

ALL of the following

Coding

Drug descriptions (formulations specified in policy)mixedCovered

1,008 mg vial	1,008 mg efgartigimod alfa / 11,200 units hyaluronidase single-dose vial (SC) - admin once weekly
1,000 mg prefilled syringe	1,000 mg efgartigimod alfa / 10,000 units hyaluronidase single-dose prefilled syringe (SC) - admin once weekly

Provider Actions & Authorization Details

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical benefit coverage of Vyvgart Hytrulo. Approvals are provided for specified durations (see approval durations) and extended approvals are allowed if the patient continues to meet the policy criteria and dosing.

Approvals are for the durations noted in the policy and may be extended if criteria continue to be met.

Documentation Required

Evidence of diagnostic support and prior therapies

For CIDP initial therapy, documentation must include electrodiagnostic studies supporting the CIDP diagnosis and evidence of prior intravenous or subcutaneous immune globulin use with inadequate efficacy or significant intolerance, or documentation of a contraindication to IV/SC immune globulin. For gMG initial therapy, documentation must include confirmed anti-acetylcholine receptor antibody positivity, MGFA clinical classification II–IV, an MG-ADL score ≥ 5, prior or current use of pyridostigmine (or documentation of inadequate efficacy, contraindication, or intolerance to pyridostigmine), and evidence of unresolved gMG symptoms.

Background & Evidence

Vyvgart Hytrulo is an SC combination of efgartigimod alfa with hyaluronidase formulated for subcutaneous injection and supplied as two presentations: a single-use vial (1,008 mg efgartigimod alfa / 11,200 units hyaluronidase) intended for administration by a healthcare professional using a winged infusion set, and a single-use prefilled syringe (1,000 mg efgartigimod alfa / 10,000 units hyaluronidase) that may be self-administered or given by a caregiver after instruction. Clinical efficacy for CIDP was demonstrated in a randomized withdrawal study showing a longer time to clinical deterioration with Vyvgart Hytrulo versus placebo (hazard ratio 0.394, 95% CI 0.253–0.614; P < 0.0001). For gMG, the SC formulation was shown to be non-inferior to the IV formulation in ADAPT-SC, with prior IV trials of Vyvgart IV demonstrating significant MG-ADL response rates versus placebo.

Brief evidence (trial results)

CIDP primary efficacy (time to deterioration)HR 0.394 (95% CI: 0.253–0.614); P < 0.0001

gMG IV trial — MG-ADL responder rateVyvgart IV 67.7% vs placebo 29.7% (P < 0.0001)

CIDP: Chronic inflammatory demyelinating polyneuropathy is a chronic peripheral nervous system disorder characterized by progressive motor and sensory dysfunction over > 8 weeks, with diagnosis relying on clinical and electrodiagnostic evidence of peripheral nerve demyelination.

Revision History

02/28/2024material_addition

CIDP condition and criteria for approval were added to the policy (CIDP initial and continuation criteria included; dosing for prefilled syringe added subsequently).

06/04/2025material_revision

For patients currently receiving Vyvgart Hytrulo for CIDP, requirement that patient is ≥ 18 years of age was added to continuation criteria.

06/11/2025material_revision

Removed the requirement that treatment cycles are no more frequent than every 50 days for gMG (stipulation removed from prescribing information and dosing section).

Policy Summary

Payerculinary health fund

PolicyPdf Neurology Vyvgart Hytrulo Um Medical De Identified_Pdf

Policy CodePolicy N/A

Change TypeMultiple material updates (2024–2026)

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization is recommended; submit documentation of diagnostic support and prior therapies and ensure the medication is prescribed by or in consultation with a neurologist.

SourceLink

On This Page

Concomitant use with another neonatal Fc receptor blocker, a complement inhibitor, a rituximab product, or Uplizna (inebilizumab-cdon intravenous infusion)
No evidence supports concomitant use
Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria
General not-recommended catch-all

Prescriber Requirement

Vyvgart Hytrulo must be prescribed by or in consultation with a physician who specializes in the condition being treated (neurologist)

Specialist prescribing requirement

Note

Specialist prescribing requirement

Vyvgart Hytrulo must be prescribed by or in consultation with a physician who specializes in the treated condition (neurologist).

Billing Rule

Approval durations

Approval durations in the policy: CIDP initial therapy approvals are for 3 months; patients currently receiving Vyvgart Hytrulo for CIDP may be approved for 1 year. gMG initial therapy approvals are for 6 months; patients currently receiving Vyvgart Hytrulo (or Vyvgart IV) may be approved for 1 year.

CIDP initial: 3 months
CIDP current users: 1 year
gMG initial: 6 months
gMG current users: 1 year

Denial Risk

Concomitant therapy exclusion

Requests for concomitant use of Vyvgart Hytrulo with another neonatal Fc receptor blocker, a complement inhibitor, a rituximab product, or Uplizna (inebilizumab) are not recommended for approval and may be denied.

Note

Off-label or other dosing requests

Requests for doses outside the established dosing documented in this policy will be reviewed on a case-by-case basis by a clinician (Medical Director or Pharmacist).

MG-ADL: The Myasthenia Gravis Activities of Daily Living (MG-ADL) is a patient-reported assessment of eight signs and symptoms affected by gMG, each scored on a 4-point scale; a higher score indicates greater impairment and an MG-ADL responder is defined as a ≥2-point reduction sustained for at least 4 consecutive weeks in trials.

MGFA: The Myasthenia Gravis Foundation of America (MGFA) clinical classification is a standardized clinical classification system used to stage disease severity (for the indications here, MGFA class II to IV is referenced in eligibility criteria).

11/05/2025material_revision

Concomitant use list revised to include Uplizna (inebilizumab) in Conditions Not Recommended for Approval.

02/18/2026non_material_revisionLatest

Selected revision entries through 02/18/2026 recorded (multiple administrative and clinical updates; last review date 02/18/2026).