Empaveli (pegcetacoplan) subcutaneous for C3G and IC-MPGN - Clinical prior authorization
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Clinical prior authorization policy for subcutaneous Empaveli (pegcetacoplan) for members (Medicaid, Commercial, Medicare) with biopsy‑confirmed Complement 3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN), including initial and renewal requirements and dosing guidance.
No material clinical or coverage changes in this revision.
Coverage Criteria for Empaveli (pegcetacoplan)
Initial Therapy
Coverage is provided when ALL of the following are met:
All conditions required
Continuation / Renewal Therapy
Coverage will be provided when ALL of the following are met:
All conditions required for renewal
Use of Empaveli (pegcetacoplan) in combination with Fabhalta (iptacopan) is not permitted. This prohibition applies to both initial therapy requests and renewal requests and is a required condition for coverage under the policy.
Empaveli is considered not medically necessary and will not meet coverage criteria when any of the following apply: UPCR < 1 g/g (equivalently, proteinuria < 1.0 g/day), eGFR < 30 mL/min/1.73 m2, or when the diagnosis of C3G or IC-MPGN is not confirmed by kidney biopsy. These thresholds apply to both initial requests and renewals and must be documented in the medical record.
Billing & Coding
| 73606-0010-xx | Empaveli 1,080 mg/20 mL solution in single-dose vials for subcutaneous infusion |
| D59.5 | Paroxysmal nocturnal hemoglobinuria [Marchiafava-Micheli] |
| N00.A | Acute nephritic syndrome with C3 glomerulonephritis |
| N00.5 | Acute nephritic syndrome with diffuse mesangiocapillary glomerulonephritis |
| N00.6 | Acute nephritic syndrome with dense deposit disease |
| N01.A | Rapidly progressive nephritic syndrome with C3 glomerulonephritis |
| N01.5 | Rapidly progressive nephritic syndrome with diffuse mesangiocapillary glomerulonephritis |
| N01.6 | Rapidly progressive nephritic syndrome with dense deposit disease |
| N02.A | Recurrent and persistent hematuria with C3 glomerulonephritis |
| N02.5 | Recurrent and persistent hematuria with diffuse mesangiocapillary glomerulonephritis |
| N02.6 | Recurrent and persistent hematuria with dense deposit disease |
Provider Actions, Documentation & Denial Triggers
Prior authorization required; 6‑month approvals
Prior authorization is required for Empaveli; initial approvals are valid for 6 months and may be renewed every 6 months thereafter when renewal criteria are met.
Medicare step therapy exemption for prior recipients
Medicare members who have previously received Empaveli within the past 365 days are not subject to step therapy requirements and are exempt from step therapy.
Required clinical documentation for authorization
Submit documentation confirming biopsy‑proven C3G or IC‑MPGN, member age, and that the drug is prescribed by or in consultation with a nephrologist; include baseline and current UPCR or proteinuria, baseline and current eGFR, evidence of maximally tolerated RAS inhibitor therapy (or documentation of intolerance/contraindication), and dosing information based on body weight.
- Kidney biopsy report confirming C3G or IC‑MPGN
- Member age (≥ 12 years for initial approval)
- Prescriber specialty: nephrologist or nephrology consultation documentation
- Baseline and current UPCR or proteinuria values
- Baseline and current eGFR (must remain ≥30 mL/min/1.73 m2 for renewal)
- Documentation of stable, maximally tolerated RAS inhibitor therapy for ≥3 months prior to initiation, or reason for intolerance/contraindication
- Dosing information (dose and schedule based on body weight)
Triggers that may lead to denial of request
Requests that do not meet all initial or renewal coverage criteria may be denied.
- No kidney biopsy confirming C3G or IC‑MPGN
- Member age under 12 years at initiation
- UPCR < 1 g/g or proteinuria < 1.0 g/day
- eGFR < 30 mL/min/1.73 m2
- Not receiving, or lacking documentation of, maximally tolerated RAS inhibitor therapy without documented intolerance/contraindication
- Use of Empaveli in combination with Fabhalta (iptacopan)
- Presence of any FDA‑labeled contraindication to Empaveli
Background
Empaveli (pegcetacoplan) is a targeted C3 complement inhibitor indicated for treatment of adults and pediatric patients aged 12 years and older with biopsy‑confirmed Complement 3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC‑MPGN) to reduce proteinuria. Clinical evidence supporting coverage includes a randomized trial demonstrating reductions in urine protein-to-creatinine ratio (UPCR) and higher rates of ≥50% UPCR reduction versus placebo with stable eGFR. Common adverse events reported include injection/infusion site reactions, fever, respiratory infections, cough, and nausea.
Definitions
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