Empaveli (pegcetacoplan) — Non-Oncology Coverage Criteria (Subcutaneous)
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Prior authorization and coverage criteria for Empaveli (pegcetacoplan) subcutaneous use to reduce proteinuria in members (≥12 years) with C3G or IC-MPGN; applies to Medicaid, Commercial, and Medicare lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria for Empaveli (pegcetacoplan)
Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
All conditions required for initial coverage.
Continuation/Renewal Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Use of Empaveli (pegcetacoplan) in combination with Fabhalta (iptacopan) is not permitted. In addition, members with any FDA‑labeled contraindications to Empaveli are excluded from coverage decisions and should not be approved for therapy.
Requests that do not meet all initial or renewal criteria may be considered not medically necessary and may be denied. Examples include absence of kidney biopsy confirmation of C3G or IC‑MPGN, proteinuria below the initiation threshold of UPCR < 1 g/g (or < 1.0 g/day), or eGFR < 30 mL/min/1.73 m2. Other grounds for exclusion include lack of nephrologist involvement, failure to document stable, maximally tolerated RAS inhibitor therapy (or documented intolerance), concomitant use with iptacopan, or any FDA‑labeled contraindication.
Coding and Clinical Thresholds
| No codes listed |
| 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, Authorization, and Documentation
Step therapy exception for recent Medicare use (365 days)
Medicare members who received Empaveli within the prior 365 days are exempt from the plan's step therapy requirements and do not need to meet step therapy prior to approval.
Required clinical documentation to support authorization
Submit documentation confirming diagnosis and monitoring: a kidney biopsy confirming C3G or IC‑MPGN, baseline and follow‑up UPCR and eGFR values, and evidence that the drug is prescribed by or in consultation with a nephrologist; include documentation of current RAS inhibitor therapy or documented intolerance/contraindication.
- Kidney biopsy report confirming C3G or IC‑MPGN.
- Baseline UPCR and serial UPCR or proteinuria measurements showing response for renewals.
- Baseline and follow‑up eGFR demonstrating ≥30 mL/min/1.73 m2 for initiation and maintenance.
- Nephrologist prescription or consultation note and documentation of stable maximally tolerated ACEI/ARB therapy or documented intolerance.
Triggers for denial if criteria not met
Requests may be denied if the coverage criteria are not met — for example, no biopsy confirmation of C3G/IC‑MPGN, member age under 12 years, UPCR below 1 g/g (or proteinuria <1.0 g/day), eGFR <30 mL/min/1.73 m2, lack of nephrologist involvement, absence of adequate RAS inhibitor therapy without documented intolerance, or concomitant use with Fabhalta (iptacopan).
- Diagnosis must be biopsy‑confirmed C3G or IC‑MPGN.
- Member must be ≥12 years of age.
- UPCR must be ≥1 g/g (or proteinuria ≥1.0 g/day) for initiation.
- eGFR must be ≥30 mL/min/1.73 m2 for initiation and renewal.
- Concomitant use with Fabhalta (iptacopan) will preclude approval.
- Lack of nephrologist prescribing/consultation or no evidence of adequate RAS inhibitor therapy (unless intolerance documented) may result in denial.
Background on Empaveli (pegcetacoplan)
Empaveli (pegcetacoplan) is a targeted C3 complement inhibitor indicated to reduce proteinuria in patients with biopsy‑confirmed C3 glomerulopathy (C3G) or immune‑complex membranoproliferative glomerulonephritis (IC‑MPGN). The agent is approved for use in adults and pediatric patients aged 12 years and older and demonstrated reductions in UPCR and improvement in renal outcomes in clinical trials.
Definitions and Abbreviations
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