CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zilbrysq (zilucoplan) — coverage criteria for generalized myasthenia gravis

Covers clinical criteria, authorization, continuation, and quantity limits for Zilbrysq (zilucoplan) for adults with anti-AChR antibody positive generalized myasthenia gravis; applies to Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZilbrysq (zilucoplan) — coverage criteria for generalized myasthenia gravis

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and document baseline MG-ADL ≥6, positive anti‑AChR serology, neurologist involvement, prior therapy history, and weight for dosing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial authorization duration

6 monthscontinuation authorization duration

28max supply / 28 days

≥6baseline MG-ADL requirement

≥2-pointrequired MG-ADL improvement

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Zilbrysq (zilucoplan)

Initial authorization (6 months)

Covered when ALL of the following are met:

Initial criteria: 1. Member is ≥ 18 years of age; 2. Prescribed by, or in consultation with, a neurologist; 3. Documentation with medical records (e.g., chart notes, laboratory values) to support the diagnosis of generalized myasthenia gravis (gMG); 4. Documentation of a positive serologic test for anti‑acetylcholine receptor (AChR) antibodies; 5. Myasthenia Gravis Foundation of America (MGFA) clinical classification of class II–IVb; 6. Baseline neurological exam documenting objective signs of weakness and fatigability (e.g., QMG or MG‑ADL); 7. Baseline MG‑ADL total score ≥6; 8. ONE of the following: (a) inadequate response to ≥1 conventional agent for MG (corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide), (b) intolerance/hypersensitivity to ≥1 conventional agent, (c) FDA‑labeled contraindication to ALL conventional agents, (d) required chronic IVIG, (e) required chronic plasmapheresis/plasma exchange; 9. Current medications that exacerbate MG have been assessed and discontinued or discontinuation is not clinically appropriate; 10. Documentation of inadequate response or contraindication to BOTH: (a) Vyvgart (efgartigimod) or Vyvgart Hytrulo, and (b) Rystiggo (rozanolixizumab) or eculizumab; 11. Not to be used in combination with eculizumab, ravulizumab, rozanolixizumab, efgartigimod (or efgartigimod/hyaluronidase), or nipocalimab; 12. Prescribed dose does not exceed weight‑based limits: <56 kg = 16.6 mg daily; 56 to <77 kg = 23 mg daily; ≥77 kg = 32.4 mg daily.

Continuation authorization (6 months)

Covered for reauthorization when ALL of the following are met:

Continuation criteria: 1. Member was previously approved for the requested drug through the plan's Pharmacy Drug Review process; 2. Documentation of positive response: ≥2‑point improvement from baseline in MG‑ADL total score sustained for ≥4 weeks (OR ≥3‑point improvement in QMG total score sustained ≥4 weeks, if available); 3. Continued prescription by, or in consultation with, a neurologist; 4. Not used in combination with eculizumab, ravulizumab, rozanolixizumab, efgartigimod (or efgartigimod/hyaluronidase), or nipocalimab; 5. Prescribed dose is consistent with FDA‑approved labeling based on current documented weight.

All indications other than the FDA‑approved indication are considered experimental/investigational. Specifically, Zilbrysq is indicated only for treatment of generalized myasthenia gravis (gMG) in adults who are anti‑acetylcholine receptor (AChR) antibody positive; uses outside that FDA‑approved population are experimental/investigational and not routinely covered.

Use of Zilbrysq for non‑FDA approved indications (other than compendial uses explicitly listed in this policy) is not medically necessary. Coverage is limited to the FDA‑approved anti‑AChR antibody positive gMG population; requests for other diagnoses should be considered investigational and denied as not medically necessary.

Coding, Dosing, and Quantity Limits

No codes listedmixed

No codes listed

Dose by weight — weight-based daily dosing tiers

<56 kg16.6 mg daily

56 to <77 kg23 mg daily

>=77 kg32.4 mg daily

Quantity limit

Per day limit1 syringe per day

Per 28 days28 syringes per 28 days

Available syringe strengths16.6 mg/0.416 mL, 23 mg/0.574 mL, 32.4 mg/0.81 mL

Prior Authorization, Documentation, and Prescriber Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial and continuation authorizations may be granted for up to 6 months when all clinical criteria are met. Requests lacking required baseline documentation will be denied.

Prior authorization required; initial approval up to 6 months when criteria met
Authorization of 6 months may be granted for continuation when response criteria met
Quantity limit: 1 syringe per day (28 syringes per 28 days)

Denial Risk

Indication Limits

Use of Zilbrysq (zilucoplan) for any indication other than FDA‑approved anti‑AChR antibody positive generalized myasthenia gravis (gMG) in adults is considered experimental/investigational and not medically necessary.

FDA‑approved indication: treatment of gMG in adults who are anti‑AChR antibody positive

Background

Zilbrysq (zilucoplan) is an FDA‑approved subcutaneous therapy indicated for the treatment of generalized myasthenia gravis in adult patients who are anti‑AChR antibody positive. The therapy is intended to reduce disease‑related weakness and fatigability in this specific seropositive gMG population and should be used in accordance with the labeled indication.

Clinical Definitions and Assessment Scales

MG-ADL — definition and use for baseline severity and response

DefinitionMyasthenia Gravis Activities of Daily Living (MG-ADL) scale assesses functional impact of MG on daily activities

Baseline useUsed to document baseline disease severity; baseline total score must be ≥6 for initial authorization

Response requirement for continuationContinuation requires ≥2-point improvement from baseline in MG-ADL total score sustained ≥4 weeks

Role in objective examMay be used as part of the baseline neurological exam to document weakness/fatigability

QMG — Quantitative Myasthenia Gravis score; alternative response measure

DefinitionQuantitative Myasthenia Gravis (QMG) score is an objective measure of neuromuscular weakness in MG

Documentation Required

Documentation and Response Requirements

Providers must submit complete baseline and follow-up documentation to support both approval and continuation. Missing baseline documentation or failure to demonstrate required response will result in denial of initial or reauthorization requests.

Required baseline documentation: age ≥18; neurologist prescribing or consultation; medical records supporting gMG diagnosis (chart notes, labs); positive anti‑AChR antibody test; MGFA clinical classification II–IVb; objective baseline neurological assessment (e.g., QMG or MG‑ADL) and baseline MG‑ADL total score ≥6; current weight for dose calculation
Required prior therapy documentation: trial and inadequate response or intolerance/contraindication to at least ONE conventional agent (e.g., corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide) OR documentation of chronic IVIG or chronic plasmapheresis/plasma exchange, OR FDA‑labeled contraindication to all conventional agents
Prior biologic therapy requirement: documentation of inadequate response or contraindication to BOTH Vyvgart (efgartigimod) or Vyvgart Hytrulo and Rystiggo (rozanolixizumab) or eculizumab
Concomitant therapy restriction: will not be used in combination with eculizumab, ravulizumab, rozanolixizumab, efgartigimod (or Hytrulo), or nipocalimab
Continuation documentation: member previously approved through plan; sustained improvement ≥2 points in MG‑ADL total score from baseline for at least 4 weeks (or ≥3‑point improvement in QMG sustained for ≥4 weeks if available); continued neurologist prescribing/consultation; prescribed dose consistent with FDA labeling and current weight