ModifiedUnitedHealthcarePolicy 2025 P 2323-2

Zilbrysq (zilucoplan) prior authorization / medical necessity policy

Defines UnitedHealthcare prior authorization and medical necessity criteria for initiation and reauthorization of Zilbrysq (zilucoplan) for adult patients with generalized myasthenia gravis who are anti-AChR antibody positive, including documentation, prescriber specialty, combination-therapy exclusions, and authorization duration.

Policy Summary

PayerUnitedHealthcare

PolicyZilbrysq (zilucoplan) prior authorization / medical necessity policy

Policy CodePolicy 2025 P 2323-2

Change TypeNew prior authorization program; annual review (references updated)

Effective DateApr 1, 2025

Next Review Date

Key ActionSubmit medical records/chart notes and laboratory values documenting diagnosis, anti-AChR antibody positivity, MGFA class II-IV, MG-ADL score >=6, prior therapy history per criteria, and prescriber specialty for prior authorization; authorization issued for 12 months.

POLICY UPDATE CHANGES

New prior authorization program created for zilucoplan (Zilbrysq) effective 4/1/2025 with initial and reauthorization criteria.

Annual review performed 1/2025 with updated listing of examples of complement inhibitors and neonatal Fc receptor blockers without change to clinical intent.

12 monthsAuthorization Duration

>=6Baseline MG-ADL score required

>=2MG-ADL improvement for reauthorization

Immunosuppressive agents failed

Coverage Summary

Zilbrysq (zilucoplan) is indicated for treatment of generalized myasthenia gravis (gMG) in adult patients who are anti‑AChR antibody positive. The policy establishes UnitedHealthcare prior authorization and medical necessity requirements consistent with the product labeling and clinical guidance, and the coverage stance is covered_with_criteria.

Key thresholds and authorization duration

Authorization Duration12 months

Baseline MG-ADL score at initiation>= 6

MG-ADL improvement required for reauthorization>= 2-point reduction from pre-treatment baseline

Prior therapy duration requirement>= 12 months (failure of >= 2 immunosuppressive agents or alternative pathway)

Plasmapheresis/IVIG courses threshold>= 4 courses over 12 months (when only one IST failed)

Initial Therapy Criteria

Initial Authorization

Zilbrysq will be approved based on all of the following criteria:

ALL of the following

Diagnosis and baseline severity
- Diagnosis of generalized myasthenia gravis (gMG)
- Positive serologic test for anti-AChR antibodies
- MGFA Clinical Classification of class II, III, or IV at initiation of therapy
- MG-ADL total score >= 6 at initiation of therapy>= 6

Continuation / Reauthorization Criteria

Reauthorization

Zilbrysq will be approved for reauthorization based on all of the following criteria:

ALL of the following

Improvement and/or maintenance of at least a 2-point improvement (reduction) in MG-ADL score from pre-treatment baseline>= 2-point improvement
Maintenance, reduction, or discontinuation of baseline immunosuppressive therapy (IST) doses compared to starting Zilbrysq; note that add-on, dose escalation of IST, or additional rescue therapy from baseline to treat MG or exacerbation of symptoms while on Zilbrysq will be considered treatment failure
Reduction in signs and symptoms of myasthenia gravis

Authorization Duration

Authorization will be issued for 12 months12 months

State mandates may apply; member benefit plan coverage may also impact coverage criteria.

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization required for Zilbrysq

Submit medical records/chart notes and laboratory values confirming diagnosis of generalized myasthenia gravis, positive anti-AChR antibody test, MGFA class II–IV at initiation, baseline MG-ADL total score >= 6, documentation of prior therapy history meeting the prior-therapy criteria, and prescriber specialty; authorization will be issued for 12 months.

Authorization duration: 12 months

Documentation Required

Documentation of baseline and ongoing effectiveness

For reauthorization, submit medical records/chart notes and laboratory tests showing at least a 2-point improvement (reduction) in MG-ADL score from pre-treatment baseline and documentation that baseline immunosuppressive therapy (IST) doses were maintained, reduced, or discontinued compared to starting Zilbrysq. Note that add-on or dose escalation of IST, or additional rescue therapy from baseline to treat MG or exacerbation while on Zilbrysq, will be considered treatment failure.

Applicable Codes

ICD-10 diagnosis codes referencedICD-10

No codes listed

Drug / product (informational)NDC|HCPCS

No codes listed

Clinical Evidence and References

Key evidence includes the pivotal RAISE phase 3 randomized, double‑blind, placebo‑controlled trial (Howard JF Jr. et al.) and the product labeling (Zilbrysq package insert, UCB Inc., April 2024).

Background and Definitions

This policy covers Zilbrysq (zilucoplan) for adults with generalized myasthenia gravis who are positive for anti‑AChR antibodies. Prior authorization is required and the policy defines clinical documentation and prescriber specialty requirements (neurologist) to ensure use consistent with labeling. The intent is to authorize initial and continued therapy when specified diagnostic, severity (e.g., MGFA class II–IV and baseline MG‑ADL ≥ 6), prior therapy, and response criteria (e.g., ≥ 2‑point improvement in MG‑ADL for reauthorization) are met, and to exclude concurrent use with other complement inhibitors or FcRn blockers.

Definitions

MG-ADL (Myasthenia Gravis Activities of Daily Living)Scale used to quantify functional impact of MG symptoms

MGFA Clinical ClassificationMyasthenia Gravis Foundation of America classes I-V describing disease severity and distribution; approval requires class II, III, or IV at initiation

Revision History

2025-04-01addedLatest

Material: New prior authorization program created (Program 2025 P 2323-2; P&T approvals 1/2024 and 1/2025) effective 2025-04-01 with initial and reauthorization criteria for Zilbrysq (zilucoplan) including diagnosis, anti-AChR positivity, MGFA class II-IV, baseline MG-ADL >=6, prior therapy requirements, combination-therapy exclusions, neurologist prescriber requirement, and 12-month authorization.

2025-01-01revised

Non-material: Annual review performed 1/2025 with updated listing of examples of complement inhibitors and neonatal Fc receptor blockers and updated references; clinical requirements unchanged.

Policy Summary

PayerUnitedHealthcare

PolicyZilbrysq (zilucoplan) prior authorization / medical necessity policy

Policy CodePolicy 2025 P 2323-2

Change TypeNew prior authorization program; annual review (references updated)

Effective DateApr 1, 2025

Next Review Date

On This Page

Prior therapy requirement (one of the following)

History of failure of at least two immunosuppressive agents over the course of at least 12 months (examples: azathioprine, corticosteroids, cyclosporine, methotrexate, mycophenolate)>= 12 months
History of failure of at least one immunosuppressive therapy AND required four or more courses of plasmapheresis/plasma exchange and/or IVIG over at least 12 months without symptom control>= 4 courses over 12 months

Patient is not receiving Zilbrysq in combination with another complement inhibitor (examples: Soliris [eculizumab], Ultomiris [ravulizumab-cwvz]) or a neonatal Fc receptor blocker (examples: Rystiggo [rozanolixizumab-noli], Vyvgart [efgartigimod alfa-fcab], Vyvgart Hytrulo [efgartigimod alfa and hyaluronidase-qvfc])

Prescribed by, or in consultation with, a neurologist

Denial Risk

Combination therapy exclusion

Concurrent use of Zilbrysq with another complement inhibitor or a neonatal Fc receptor (FcRn) blocker is an exclusion and will result in denial of coverage. Examples include complement inhibitors Soliris (eculizumab) and Ultomiris (ravulizumab-cwvz), and FcRn blockers Rystiggo (rozanolixizumab-noli), Vyvgart (efgartigimod alfa-fcab), and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc).

Documentation Required

Prescriber specialty requirement

Zilbrysq must be prescribed by, or in consultation with, a neurologist.