CurrentColorado Rocky Mountain Health PlansPolicy N/A

Empaveli (pegcetacoplan) — Prior authorization and medical necessity

Prior authorization and medical necessity criteria for Empaveli (pegcetacoplan) for treatment of PNH in adults and C3G/IC‑MPGN in patients ≥12 years, including diagnostic confirmation, prescriber specialty, initial and reauthorization requirements, and prohibitions on concurrent complement inhibitors.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyEmpaveli (pegcetacoplan) — Prior authorization and medical necessity

Policy CodePolicy N/A

Change TypeAdded indications + authorization standardization

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with required diagnostic confirmation (flow cytometry for PNH; kidney biopsy immunofluorescence and complement testing for C3G/IC‑MPGN).

SourceLink

POLICY UPDATE CHANGES

Added criteria for new FDA‑approved indications C3G and IC‑MPGN.

Initial authorization duration standardized to 12 months.

Therapeutic duplication/combination with other complement inhibitors prohibited.

12 monthsauthorization duration

PNH; C3G; IC‑MPGNindications covered

≥12 yrsage for renal indications

Flow cytometry

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Coverage and Medical Necessity Criteria

Initial Therapy — PNH

Covered when ALL of the following are met:

ALL of the following

Submission of medical records (e.g., chart notes, laboratory values) documenting the diagnosis of paroxysmal nocturnal hemoglobinuria (PNH)
Diagnostic confirmation
- Flow cytometry analysis confirming presence of PNH clones
Laboratory results, signs, and/or symptoms attributed to PNH (e.g., abdominal pain, anemia, dyspnea, extreme fatigue, smooth muscle dystonia, unexplained/unusual thrombosis, hemolysis/hemoglobinuria, kidney disease, pulmonary hypertension)
Concomitant therapy exclusion (must meet one)
- Patient will not be prescribed Empaveli in combination with another complement inhibitor used for the treatment of PNH (e.g., Bkemv, Epysqli, Fabhalta, PiaSky, Soliris, Ultomiris)
Prescribed by, or in consultation with, a hematologist or oncologist

Reauthorization — PNH

Covered when ALL of the following are met:

ALL of the following

Documentation of positive clinical response to Empaveli therapy (e.g., increased or stabilization of hemoglobin levels, reduction in transfusions, improvement in hemolysis, decrease in LDH, increased reticulocyte count)
Concomitant therapy exclusion (must meet one)
- Patient is not receiving Empaveli in combination with another complement inhibitor used for the treatment of PNH (e.g., Bkemv, Epysqli, Fabhalta, PiaSky, Soliris, Ultomiris)
Prescribed by, or in consultation with, a hematologist or oncologist
Authorization will be issued for 12 months
Operational: document response in chart notes and labs showing clinical benefit over prior authorization period.

Initial Authorization Rules

Initial Therapy — General

Covered when ALL of the following general initial authorization criteria are met:

Initial_TopLevel: (1) Submission of supporting medical records documenting the diagnosis using the required diagnostic confirmation for the indication (flow cytometry for PNH; immunofluorescence microscopy on kidney biopsy and appropriate complement testing/exclusion of secondary causes for C3G/IC‑MPGN); (2) Therapy is not prescribed in combination with another complement inhibitor for the same treated condition; (3) Prescribed by, or in consultation with, the appropriate specialist (hematologist/oncologist for PNH; nephrologist for renal indications); (4) Intended clinical benefit aligns with the indication (e.g., reduction of proteinuria for renal indications)

Initial approvals issued for 12 months

Continuation / Reauthorization Rules

Continuation Therapy / Reauthorization — General

Covered when ALL of the following general continuation/reauthorization criteria are met:

Continuation_General: (1) Documentation of positive clinical response: for PNH, clinical and laboratory improvement (e.g., hemoglobin stabilization/increase, fewer transfusions, improved markers of hemolysis); for C3G/IC‑MPGN, demonstrable reduction in proteinuria; (2) For renal indications, disease severity and prior therapy history may be required (e.g., proteinuria ≥ 1.5 g/day, abnormal kidney function, and history of glucocorticoid failure/contraindication/intolerance); (3) Patient is not receiving Empaveli with another complement inhibitor for the same indication; (4) Prescribed by, or in consultation with, the appropriate specialist (hematologist/oncologist for PNH; nephrologist for renal indications)

Authorization periods are 12 months

Provider Requirements, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required — Diagnostic Confirmation

Prior authorization required. Diagnostic confirmation must be submitted with the prior authorization request to support the indicated diagnosis.

Flow cytometry confirming PNH clones required for PNH requests
Kidney biopsy immunofluorescence and complement testing required for C3G / IC‑MPGN requests

Prior Authorization

Concomitant ACE inhibitor/ARB Requirement

Renal patients must be receiving a maximally tolerated ACE inhibitor or ARB unless there is a documented contraindication, allergy, or intolerance. Provide medication records showing dose stabilization and tolerability.

Documented stabilized dose of ACE inhibitor (e.g., captopril, enalapril) or ARB (e.g., candesartan, valsartan)
If ACEi/ARB not used, include documentation of allergy, contraindication, or intolerance

Key Coding and Thresholds

Proteinuria threshold

Proteinuria threshold for reauthorizationProteinuria ≥ 1.5 g/day defines moderate–severe disease and is used as the numeric threshold for C3G/IC‑MPGN reauthorization

Authorization periodReauthorizations (and initial approvals) are issued for 12 months

Required evidence of responseDocumentation must show a reduction in proteinuria to support continued therapy

Clinical Definitions

IC‑MPGN definition

Definition (IC‑MPGN)Immune complex/monoclonal immunoglobulin‑mediated membranoproliferative glomerulonephritis confirmed by immunofluorescence microscopy on kidney biopsy with all secondary causes excluded (infections such as hepatitis B/C, chronic bacterial/parasitic infections; autoimmune diseases e.g., SLE, Sjogren's, rheumatoid arthritis; and monoclonal gammopathy).

Exclusion — kidney transplantPatient must not have had a prior kidney transplant to meet initial authorization criteria for IC‑MPGN

Purpose of biopsyImmunofluorescence microscopy on kidney biopsy is required to confirm the diagnosis and guide exclusion of secondary causes

C3G definition

Definition (C3G)Complement 3 glomerulopathy confirmed by immunofluorescence microscopy on kidney biopsy plus supporting complement abnormalities (e.g., serum C3 < 77 mg/dL or other abnormalities such as elevated sC5b‑9, abnormal factor H/B/I, or C3/C4/C5 nephritic factors).

Background and Indications

Pegcetacoplan (Empaveli) is a complement inhibitor indicated for treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) and for adults and pediatric patients aged ≥12 years with complement 3 glomerulopathy (C3G) or immune‑complex membranoproliferative glomerulonephritis (IC‑MPGN) to reduce proteinuria. Diagnosis of PNH relies on flow cytometry detection of PNH clones; diagnosis of C3G or IC‑MPGN requires kidney biopsy with immunofluorescence and exclusion of secondary causes, and treatment for renal indications is intended to reduce proteinuria.

Step Therapy / Preceding Therapeutic Requirements

Step	Requirement
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Policy Revision History

2026-01-01effective_dateLatest

Policy effective date updated to 2026-01-01 reflecting current document version.

2025-10material_addition

Added coverage criteria for new FDA‑approved indications: C3 glomerulopathy (C3G) and immune-complex membranoproliferative GN (IC‑MPGN); updated background and references.

2024-04therapeutic_duplication_rule