Complement inhibitors prior authorization (PA) summary
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This document summarizes prior authorization criteria for complement inhibitor medications for Georgia Medicaid Fee-for-Service members and explains PA process, exceptions, billing notes, and related program links. It affects prescribers and providers seeking coverage for listed complement inhibitor drugs.
No material clinical or coverage changes in this revision.
Drug-specific Coverage Criteria
Empaveli
Empaveli (pegcetacoplan) approvals
Must be prescribed by or in consultation with a hematologist, nephrologist or other specialist.
Must be prescribed by or in consultation with a hematologist, nephrologist or other specialist.
Voydeya
Voydeya (danicopan) approvals
Must be prescribed by or in consultation with a hematologist or other specialist managing PNH.
Tavneos
Tavneos (avacopan) approvals
Must be prescribed by or in consultation with a rheumatologist, nephrologist or immunologist.
Zilbrysq
Zilbrysq (zilucoplan) approvals
Must be prescribed by or in consultation with a neurologist or other specialist in managing myasthenia gravis.
Exceptions to the listed conditions of coverage may be considered on a case-by-case basis through the prior authorization process. To request an exception, providers should initiate a prior authorization with OptumRx at 1-866-525-5827. No other explicit exclusions are specified in the policy.
Key Clinical Thresholds and Definitions
Prior Authorization, Billing, and Requirements for Providers
Prior authorization required — approvals based on listed clinical criteria
Prior authorization is required for all listed complement inhibitor medications; approvals are granted only when the drug-specific clinical criteria are met, including confirmed diagnosis, required age, specified laboratory thresholds, prior treatment failures or contraindications, and that the drug is prescribed by or in consultation with the appropriate specialist. Initiate PA via OptumRx as described in the PA process guidance.
- Approvals require documented diagnosis confirmation (e.g., PNH flow cytometry, anti-AChR antibody for gMG, C3G/IC‑MPGN criteria).
- Age thresholds (e.g., Empaveli and Voydeya ≥18, Empaveli C3G ≥12, Zilbrysq ≥18) must be met.
- Lab thresholds (e.g., Hb <10.5 g/dL for PNH agents; UPCR, proteinuria, eGFR for C3G) must be documented.
- Document prior inadequate response, intolerance, contraindication, or drug interaction to required prior agents where specified.
- Must be prescribed by or in consultation with the listed specialist for each drug.
Zilbrysq step requirements — required prior therapies and failures
For Zilbrysq, prior authorization requires documented failure of two immunosuppressive therapies in the prior 12 months, or failure of one immunosuppressive plus at least four courses of plasmapheresis/plasma exchange and/or IVIG in the prior 12 months; the member must also have tried Soliris and failed or have an allergy/contraindication/intolerable side effect to Soliris.
- Two distinct immunosuppressive therapies tried and failed within the last 12 months (examples listed in policy).
- Or one immunosuppressive therapy tried and failed plus ≥4 courses of plasmapheresis/plasma exchange and/or IVIG in the last 12 months.
- Documentation that Soliris (eculizumab) was tried and failed or is unsuitable due to allergy/contraindication/drug interaction or intolerable side effect.
Billing and prior authorization process for office-administered medications
If the medication is administered in a physician's office or clinic, bill through the DCH physician services program (not the outpatient pharmacy program) and follow the DCH prior authorization request process as provided online.
- Billing for office/clinic-administered medication must use the DCH physician services program (see www.mmis.georgia.gov).
- Use the DCH PA Request Process Guide for submitting authorization requests (www.dch.georgia.gov/priorauthorization-process-and-criteria).
Exceptions considered via prior authorization; noncompliance risks denial
Exceptions to the stated conditions of coverage are handled through the prior authorization process; failure to meet the PA criteria as documented may result in denial of the request.
- Initiate the PA process (OptumRx at 1-866-525-5827) to request an exception.
- If documentation does not meet the published criteria, the PA request may be denied.
Initial Therapy Approval Rules
Initial therapy criteria
Initial approval criteria per drug
Required Prior Therapies and Failures
| Required prior therapies or failures before Zilbrysq |
|---|
| Member has tried two immunosuppressive therapies (e.g., glucocorticoids, azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus) over the last 12 months and failed to achieve an adequate response. |
| OR member has tried at least one immunosuppressive therapy and required four or more courses of plasmapheresis/plasma exchange and/or IVIG over the last 12 months without symptom control. |
| AND member has tried Soliris (eculizumab) and failed to achieve an adequate response or has an allergy, contraindication, drug–drug interaction, or intolerable side effect to Soliris. |
Diagnostic Confirmation and Disease-specific Criteria
Administration Site and Billing
Office-administered medication billing — use DCH physician services program
When medications are given in a physician office or clinic, they must be billed through the DCH physician services program instead of the outpatient pharmacy program.
- Refer to www.mmis.georgia.gov for information about the physician services program billing procedures.
Clinical Background
Complement inhibitors are indicated for disorders driven by dysregulation of the complement pathway, including paroxysmal nocturnal hemoglobinuria (PNH), C3 glomerulopathy / primary immune-complex MPGN, ANCA-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis), and generalized myasthenia gravis. This policy links coverage to objective diagnostic confirmation (for example, flow cytometry for PNH), specified laboratory thresholds (such as hemoglobin < 10.5 g/dL, UPCR > 1 g/g, proteinuria > 1.5 g/day, and eGFR > 30 mL/min/1.73 m2), prior treatment failure or contraindication to alternative complement inhibitors when required, and management or consultation by an appropriate specialist.
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