ModifiedUnitedHealthcarePolicy 2025 P 1428-2

Zilbrysq (zilucoplan) prior authorization

UnitedHealthcare prior authorization policy for Zilbrysq (zilucoplan) for treatment of generalized myasthenia gravis (gMG) in adults, specifying initial and reauthorization clinical criteria, duration of approval, and additional program rules.

Policy Summary

PayerUnitedHealthcare

PolicyZilbrysq (zilucoplan) prior authorization

Policy CodePolicy 2025 P 1428-2

Change TypeAnnual review; program created (no material clinical changes)

Effective DateApr 1, 2025

Next Review Date

Key ActionPrior authorization/notification is required for Zilbrysq; approvals issued for 12 months for initial and reauthorization requests.

POLICY UPDATE CHANGES

Annual review updated listing of examples of complement inhibitors and neonatal Fc receptor blockers without change to clinical intent.

Program created as prior authorization/notification for Zilbrysq with P&T approval dates 1/2024 and 1/2025.

12 monthsAuth Duration

3Initial Criteria

2Reauth Criteria

Covered w/ criteriaCoverage Stance

Coverage Summary

UnitedHealthcare prior authorization policy for Zilbrysq (zilucoplan) for treatment of generalized myasthenia gravis (gMG) in adults: covered with clinical criteria and prior authorization requirements. Initial authorization requires diagnosis of gMG and positive anti-AChR antibody testing and other criteria; reauthorization requires documentation of positive clinical response. Approvals are issued for 12 months. Effective date: 2025-04-01.

Initial Therapy Criteria

Initial Authorization

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

ALL of the following

Diagnosis of generalized myasthenia gravis (gMG)
Serology: Positive serologic test for anti-AChR antibodies
Combination therapy exclusion: Patient is not receiving Zilbrysq in combination with another complement inhibitor or a neonatal Fc receptor blocker
Examples listed: complement inhibitors e.g., Soliris (eculizumab), Ultomiris (ravulizumab-cwvz); neonatal Fc receptor blockers e.g., Rystiggo (rozanolixizumab-noli), Vyvgart (efgartigimod alfa-fcab), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)

Authorization duration: Authorization will be issued for 12 months.

Continuation / Reauthorization Criteria

Reauthorization

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

ALL of the following

Clinical response: Documentation of positive clinical response to Zilbrysq therapy
Combination therapy exclusion: Patient is not receiving Zilbrysq in combination with another complement inhibitor or a neonatal Fc receptor blocker
Examples listed: complement inhibitors e.g., Soliris (eculizumab), Ultomiris (ravulizumab-cwvz); neonatal Fc receptor blockers e.g., Rystiggo (rozanolixizumab-noli), Vyvgart (efgartigimod alfa-fcab), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)

Authorization duration: Authorization will be issued for 12 months.

Exclusions / Combination Therapy

Combination therapy exclusion: claims will not meet criteria if Zilbrysq is used in combination with another complement inhibitor or a neonatal Fc receptor blocker (examples include Soliris/eculizumab, Ultomiris/ravulizumab-cwvz, Rystiggo/rozanolixizumab-noli, Vyvgart/efgartigimod products). Providers should document absence of such combination therapy. Supply limits may apply.

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization/notification is required for Zilbrysq. Approvals (initial and reauthorization) are issued for 12 months.

Documentation Required

Clinical documentation for reauthorization

For reauthorization, providers must document a positive clinical response to Zilbrysq therapy.

Documentation Required

Combination therapy exclusion

Confirm the patient is not receiving Zilbrysq in combination with another complement inhibitor or a neonatal Fc receptor blocker. Examples include complement inhibitors such as Soliris (eculizumab) and Ultomiris (ravulizumab-cwvz), and neonatal Fc receptor blockers such as Rystiggo (rozanolixizumab-noli), Vyvgart (efgartigimod alfa-fcab), and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc). Claims will not meet criteria if used in combination; documentation should confirm absence of such combination therapy.

Examples of complement inhibitors: Soliris (eculizumab), Ultomiris (ravulizumab-cwvz)
Examples of neonatal Fc receptor blockers: Rystiggo (rozanolixizumab-noli), Vyvgart (efgartigimod alfa-fcab), Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)

Billing Rule

Program may use automated approvals

UnitedHealthcare may approve initial and reauthorization requests based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic; use of automated approval and re-approval processes varies by program.

Billing Rule

Supply limits may apply

Supply limits may be in place for Zilbrysq dispensing; quantity or supply restrictions could apply.

Definitions

Complement inhibitor: Medications that inhibit the complement pathway; examples listed include eculizumab (Soliris) and ravulizumab (Ultomiris).

Neonatal Fc receptor blocker: Medications that block the neonatal Fc receptor; examples listed include rozanolixizumab (Rystiggo) and efgartigimod products (Vyvgart, Vyvgart Hytrulo).

Revision History

1/2024Program created

Program created as prior authorization/notification for Zilbrysq (P&T approval recorded).

1/2025Program approved

Program entry recorded with P&T approval (prior authorization/notification for Zilbrysq).

2024-04Reference updated; clinical criteria unchanged

April 2024 package insert update and annual review: updated listing of examples of complement inhibitors and neonatal Fc receptor blockers and updated reference; no change to clinical intent (non-material).

4/1/2025Effective dateLatest

Policy effective date set.