CurrentMass General Brigham Health PlanPolicy N/A

Zilbrysq (zilucoplan) — Coverage Criteria for Generalized Myasthenia Gravis

This policy governs prior authorization, specialty pharmacy designation, and coverage criteria for Zilbrysq (zilucoplan) for adult patients with anti‑AChR antibody positive generalized myasthenia gravis under Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyZilbrysq (zilucoplan) — Coverage Criteria for gMG

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and ensure the medication is filled at a contracted specialty pharmacy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moInitial approval duration

12 moReauthorization approval duration

Adults AChR+Indication population

SpecialtyDispensing requirement

Coverage Criteria for Zilbrysq (zilucoplan)

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inv-01: Initial Authorization

Covered when ALL of the following are met:

Initial coverage criteria: Member has diagnosis of generalized myasthenia gravis (gMG); member is anti‑acetylcholine receptor (AChR) antibody positive; MGFA clinical classification II to IV; member meets two of the following subcriteria (see children).

Two of the following must be met

MG‑ADL criterion: MG‑ADL total score of ≥2
Prior immunosuppressive therapy failure: Inadequate response or adverse reaction to at least one of: azathioprine; cyclosporine; mycophenolate mofetil; tacrolimus; methotrexate; cyclophosphamide; rituximab
Cholinesterase inhibitor: Inadequate response or adverse reaction to cholinesterase inhibitor (e.g., pyridostigmine)
IVIG/SCIG failure: Inadequate response or adverse reaction to immune globulin (IVIG or SCIG)
C5 inhibitor failure: Inadequate response or adverse reaction to eculizumab (Soliris) or a long‑acting C5 inhibitor (e.g., Ultomiris)

For members who have been enrolled in the plan for less than 90 days, prior authorization requests for ongoing treatment with the requested medication will be reviewed to determine coverage eligibility. The policy specifically notes that such reviews apply when the member is currently receiving the medication. Documentation that the medication was obtained only as samples or through the manufacturer's patient assistance program will not be considered evidence of current therapy for purposes of automatic authorization continuance.

Provider Requirements, Prior Auth, and Documentation

Prior Authorization

Prior authorization and specialty pharmacy dispensing required

Prior authorization is required for Zilbrysq (zilucoplan). The medication is designated specialty and must be dispensed through a contracted specialty pharmacy.

Step Therapy

Required prior treatment failures (step therapy)

Member must have had inadequate response or an adverse reaction to specified prior therapies as part of meeting coverage criteria; the policy lists required prior immunosuppressive agents and other therapies (IVIG/SCIG, eculizumab/Ultomiris) as acceptable prior treatment failures.

At least one inadequate response/adverse reaction to an immunosuppressive: azathioprine; cyclosporine; mycophenolate mofetil; tacrolimus; methotrexate; cyclophosphamide; or rituximab.
Or inadequate response/adverse reaction to a cholinesterase inhibitor (e.g., pyridostigmine).
Or inadequate response/adverse reaction to immune globulin (IVIG or SCIG).
Or inadequate response/adverse reaction to a C5 inhibitor such as eculizumab (Soliris) or Ultomiris.

Documentation Required

Required clinical documentation for authorization

Documentation submitted with the authorization must demonstrate generalized myasthenia gravis diagnosis, anti‑AChR antibody positive status, MGFA clinical classification II–IV, and baseline and response measures (MG‑ADL and/or QMG), plus records of prior trials or intolerances to specified therapies.

Diagnosis of generalized myasthenia gravis (gMG).
Anti‑acetylcholine receptor (AChR) antibody positive status.
MGFA clinical classification score II to IV.
Baseline and follow-up MG‑ADL and/or QMG scores to document response.
Documentation of prior trials or intolerances to listed immunosuppressive agents or prior treatments (e.g., IVIG, eculizumab/Ultomiris).

Denial Risk

New-to-plan treatment review may result in denial

Authorizations for members new to the plan within the past 90 days may be reviewed and can be denied if the member is not currently receiving the requested medication; samples and manufacturer's patient assistance programs are excluded from consideration as proof of current treatment.

If member joined the plan within the last 90 days and is not actively receiving the medication, authorization may be denied.
Medication obtained only as samples or via manufacturer patient assistance programs does not qualify as current treatment.

Background on Zilbrysq (zilucoplan)

Zilbrysq (zilucoplan) is a complement inhibitor indicated for treatment of adult patients with generalized myasthenia gravis (gMG) who are anti‑acetylcholine receptor (AChR) antibody positive. Coverage is conditioned on clinical criteria that require an applicable MGFA classification (class II–IV) and meeting at least two of several treatment or scoring criteria, including an MG‑ADL total score threshold of ≥2 or documented inadequate response/intolerance to prior therapies (examples include selected immunosuppressive agents, cholinesterase inhibitors, IVIG/SCIG, or C5 inhibitors such as eculizumab/Ultomiris). Initial approvals are granted for 6 months with reauthorization permitted for 12 months when a positive response to therapy (improvement in MG‑ADL or changes in QMG from baseline) is documented. Prior authorization is required and the drug is designated as a specialty medication requiring fill at a contracted specialty pharmacy.

Clinical Definitions and Response Criteria

Positive response to therapy

Definition of positive responseImprovement in MG-ADL score or changes in Quantitative Myasthenia Gravis (QMG) total score compared to baseline

PurposeRequired evidence for reauthorization/continuation of therapy

DocumentationProviders must supply MG-ADL and/or QMG baseline and follow-up measures to demonstrate improvement

MGFA clinical classification

Required MGFA classesMyasthenia Gravis Foundation of America (MGFA) clinical classification class II to IV

Role in coverageMGFA II–IV is a mandatory criterion in the initial authorization pathway

Documentation expectationClinical record must state MGFA class to support eligibility

OpenPayer

Zilbrysq (zilucoplan) — Coverage Criteria for Generalized Myasthenia Gravis

Coverage Criteria for Zilbrysq (zilucoplan)

Pharmacy/Benefit Designations and Clinical Scores

Provider Requirements, Prior Auth, and Documentation

Background on Zilbrysq (zilucoplan)

Clinical Definitions and Response Criteria