CurrentColorado Rocky Mountain Health PlansPolicy N/A

Zilbrysq (zilucoplan) prior authorization

Prior authorization and reauthorization requirements for Zilbrysq (zilucoplan) for treatment of generalized myasthenia gravis in adult members of Colorado Rocky Mountain Health Plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyZilbrysq (zilucoplan) prior authorization

Policy CodePolicy N/A

Change TypeMaterial revision — examples updated

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain positive anti-AChR serology and document clinical response for reauthorization; do not co-administer Zilbrysq with other complement inhibitors or FcRn blockers for the same condition.

SourceLink

POLICY UPDATE CHANGES

Modified concomitant use statement and added Imaavy to the list of examples of FcRn blockers.

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

12 monthsAuthorization duration (initial and reauthorization)

anti-AChR positiveRequired serologic status for coverage

adult gMGIndication population

No concomitant complement inhibitor or FcRn blockerConcomitant therapy exclusion

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Coverage Criteria for Zilbrysq (zilucoplan)

Initial Therapy

Covered when ALL of the following are met:

Initial Authorization: Diagnosis of generalized myasthenia gravis (gMG).

Initial Authorization: Positive serologic test for anti-AChR antibodies.

Initial Authorization: Patient is not receiving Zilbrysq in combination with any of the following for treatment of the same condition: (1) Another complement inhibitor (e.g., eculizumab, Ultomiris [ravulizumab]); (2) An FcRn blocker (e.g., Imaavy [nipocalimab], Rystiggo [rozanolixizumab], Vyvgart [efgartigimod alfa], Vyvgart Hytrulo [efgartigimod alfa and hyaluronidase]).

Authorization will be issued for 12 months.

Continuation Therapy / Reauthorization

Covered when ALL of the following are met:

Reauthorization: Documentation of positive clinical response to Zilbrysq therapy.

Reauthorization: Patient is not receiving Zilbrysq in combination with any of the following for treatment of the same condition: (1) Another complement inhibitor (e.g., eculizumab, Ultomiris [ravulizumab]); (2) An FcRn blocker (e.g., Imaavy [nipocalimab], Rystiggo [rozanolixizumab], Vyvgart [efgartigimod alfa], Vyvgart Hytrulo [efgartigimod alfa and hyaluronidase]).

Authorization will be issued for 12 months; state mandates and member benefit plan coverage may apply.

Coverage of Zilbrysq (zilucoplan) excludes use in combination with other agents that target the same immunologic pathways for treatment of the same condition. Specifically, Zilbrysq must not be used concomitantly with another complement inhibitor (for example, eculizumab or Ultomiris [ravulizumab]) or with an FcRn blocker (for example, Imaavy [nipocalimab], Rystiggo [rozanolixizumab], Vyvgart [efgartigimod alfa], or Vyvgart Hytrulo [efgartigimod alfa and hyaluronidase]) for treatment of the same condition.

Initial Authorization Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial: Diagnosis of generalized myasthenia gravis (gMG).

Initial: Positive serologic test for anti-AChR antibodies.

Initial: Not used concomitantly with another complement inhibitor or an FcRn blocker for treatment of the same condition (examples: eculizumab; ravulizumab [Ultomiris]; nipocalimab [Imaavy]; rozanolixizumab [Rystiggo]; efgartigimod alfa [Vyvgart]; Vyvgart Hytrulo).

Approval/authorization issued for 12 months.

Reauthorization / Continuation Criteria

Reauthorization

Covered when ALL of the following are met:

Reauthorization: Documentation of positive clinical response to Zilbrysq therapy (clinical benefit).

Reauthorization: Patient is not receiving Zilbrysq in combination with another complement inhibitor or an FcRn blocker for treatment of the same condition (examples include eculizumab; ravulizumab; nipocalimab [Imaavy]; rozanolixizumab [Rystiggo]; efgartigimod alfa [Vyvgart]).

Authorization will be issued for 12 months; state mandates and benefit plan coverage may affect reauthorization.

Provider Actions and Operational Rules

Prior Authorization

Initial Authorization — diagnosis and positive anti‑AChR antibody test required; submission must document both

Initial Authorization — Prior to submission, ensure the chart documents a diagnosis of generalized myasthenia gravis (gMG) and a positive serologic test for anti‑AChR antibodies. Authorization will be issued for 12 months.

Requirement: Diagnosis of generalized myasthenia gravis (gMG)
Requirement: Positive anti‑AChR antibody test
Authorization duration: 12 months

Documentation Required

Reauthorization documentation

Reauthorization requires documentation of a positive clinical response to Zilbrysq therapy. Also confirm the member is not receiving Zilbrysq concomitantly with excluded agents (see exclusion callout).

Documentation: Positive clinical response to Zilbrysq

Key Definitions

Complement inhibitor

DefinitionAgents that inhibit complement activity (terminal complement pathway) used in autoimmune and complement‑mediated diseases.

ExamplesEculizumab (brand: Soliris); Ravulizumab (brand: Ultomiris).

Context in policyPolicy excludes concomitant use of Zilbrysq with another complement inhibitor for treatment of the same condition.

FcRn blocker

DefinitionAgents that block the neonatal Fc receptor (FcRn) to reduce circulating pathogenic IgG antibodies.

ExamplesNipocalimab (Imaavy); Rozanolixizumab (Rystiggo); Efgartigimod alfa (Vyvgart and Vyvgart Hytrulo).

Background

Zilbrysq (zilucoplan) is a complement inhibitor indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti‑acetylcholine receptor (AChR) antibody positive. The policy limits coverage to this population and requires confirmation of anti‑AChR seropositivity as part of prior authorization.

Step Therapy and Supply Limits

Process	Criteria for Automated Approval / Re-approval	Supply limits / Operational Notes
Automated initial approval	May be granted based on prior claim/medication history, relevant diagnosis codes (ICD-10), and claim logic without additional clinical documentation	Supply limits may be applied per program; specific limits determined by benefit design and claim adjudication rules
Automated re-authorization	May be granted using prior authorization history, recent claim activity, and diagnosis/clinical coding to demonstrate ongoing therapy and benefit	Re-approval subject to same supply limits; duration of authorization typically 12 months per policy rules
Manual review trigger	Instances lacking sufficient prior claim/medication evidence, unclear diagnosis coding, or potential concomitant use with excluded agents will require clinician-submitted documentation	Concomitant use with another complement inhibitor or an FcRn blocker is excluded and will trigger denial on review (operational alert)