CurrentUnitedHealthcarePolicy 1 = 2025 P 1361-7

Empaveli (pegcetacoplan) prior authorization - Prior Authorization/Notification for PNH and C3G/IC-MPGN

Prior authorization and notification rules for Empaveli (pegcetacoplan) for treatment of PNH and for C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis in ages ≥12; affects prescribers and payers under UnitedHealthcare pharmacy/clinical programs.

Policy Summary

PayerUnitedHealthcare

PolicyEmpaveli (pegcetacoplan) prior authorization - Prior Authorization/Notification for PNH and C3G/IC-MPGN

Policy CodePolicy 1 = 2025 P 1361-7

Change TypeUpdated indicationsrevised authorization rules

Effective Date1/1/2026

Next Review Date

Key ActionSubmit documentation of confirmed diagnosis and for reauthorization provide evidence of positive clinical response (reduction in proteinuria for C3G/IC-MPGN).

SourceLink

POLICY UPDATE CHANGES

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

Revised initial authorization to 12 months and included criteria for therapeutic duplication.

Simplified criteria language for converting to new complement inhibitor therapy.

12 monthsauthorization duration

PNH; C3G; IC-MPGNindications

≥12 yearsage requirement

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Prior Auth/Notificationprogram type

Coverage Criteria

Initial Authorization — PNH

Covered when ALL of the following are met

PNH initial authorization: (1) Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH); AND (2) ONE of the following: (a) 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); OR (b) Patient is currently receiving another complement inhibitor which will be discontinued and Empaveli will be initiated in accordance with FDA-approved labeling

Authorization issued for 12 months

Reauthorization — PNH

Covered when ALL of the following are met

PNH reauthorization: (1) Documentation of positive clinical response to Empaveli therapy; AND (2) 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)

Authorization issued for 12 months

Initial Authorization — C3G/IC-MPGN

Covered when ALL of the following are met

C3G/IC-MPGN initial authorization: (1) Diagnosis of one of the following: C3 glomerulopathy (C3G) OR primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN); AND (2) Patient is not receiving Empaveli in combination with another complement inhibitor used for the treatment of C3G or IC-MPGN (e.g., Bkemv, Epysqli, Fabhalta, PiaSky, Soliris, Ultomiris)

Authorization issued for 12 months

Reauthorization — C3G/IC-MPGN

Covered when ALL of the following are met

C3G/IC-MPGN reauthorization: (1) Documentation of positive clinical response to Empaveli therapy demonstrated by a reduction in proteinuria; AND (2) Patient is not receiving Empaveli in combination with another complement inhibitor used for the treatment of C3G or IC-MPGN (e.g., Bkemv, Epysqli, Fabhalta, PiaSky, Soliris, Ultomiris)

Authorization issued for 12 months

Concurrent prescription of Empaveli (pegcetacoplan) with another complement inhibitor for the same indication is not covered. Requests where Empaveli is to be used in combination with another complement inhibitor for PNH, C3G, or IC‑MPGN may be denied; switching from a prior complement inhibitor is permitted only when the prior agent will be discontinued and Empaveli is initiated in accordance with FDA labeling. Authorization in eligible cases is issued for 12 months.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required for Initial Therapy

Initial authorization: Empaveli approvals follow the policy-specific clinical criteria for each indication (PNH, C3G/IC-MPGN). Authorizations are generally issued for 12 months when criteria are met. Do not initiate Empaveli in combination with another complement inhibitor for the same indication unless switching from an existing complement inhibitor in accordance with FDA labeling.

PNH: Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH) AND either (a) patient will not be prescribed Empaveli in combination with another complement inhibitor for PNH, OR (b) patient is switching from another complement inhibitor and Empaveli will be initiated per FDA labeling. Authorization = 12 months.
C3G/IC‑MPGN: Diagnosis of C3 glomerulopathy (C3G) (or IC‑MPGN as specified in policy) AND patient is not receiving Empaveli in combination with another complement inhibitor used for C3G/IC‑MPGN. Authorization = 12 months.

Documentation Required

Reauthorization Requirements

Reauthorization requires documentation of clinical benefit and continued non‑duplication of complement inhibitor therapy. Authorizations are generally issued for 12 months when reauthorization criteria are met.

Initial Therapy Criteria

Initial Therapy

Initial authorization

Initial therapy rules: Diagnosis must match the indicated condition (PNH, C3G, or IC-MPGN) and Empaveli must not be used in combination with another complement inhibitor; switching from another complement inhibitor is allowed if the prior inhibitor will be discontinued and Empaveli initiated per FDA labeling

Authorization issued for 12 months

Reauthorization / Continuation Criteria

Reauthorization/Continuation

Reauthorization

Continuation therapy: Documentation of positive clinical response is required; patient must not be receiving Empaveli in combination with another complement inhibitor; for C3G/IC-MPGN, positive response is demonstrated by reduction in proteinuria

Authorization issued for 12 months

Step Therapy and Automated Approvals

Process	Description
Automated approval / re-approval	UnitedHealthcare may use automated approval and re-approval processes based on previous claim or medication history, diagnosis codes (ICD-10), and/or claim logic. Use of these claims-based programs varies by program and therapeutic class.
Claims-only approval pathway	Notwithstanding the coverage criteria, initial and reauthorization decisions may be made solely on the basis of prior claims or medication history and diagnosis coding without additional clinical documentation.
Supply limits and program variation	Supply limits and other utilization management program rules may apply; availability and specifics of automated processes vary by program and therapeutic class.

Background

Empaveli (pegcetacoplan) is a complement inhibitor indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). The policy has been expanded to also cover Empaveli for C3 glomerulopathy (C3G) and primary immune‑complex membranoproliferative glomerulonephritis (IC‑MPGN) in patients aged 12 years and older, where treatment is intended to reduce proteinuria. Coverage is managed through prior authorization with requirements specific to initial and reauthorization requests.

Definitions and Clinical Measures

PNH — key facts

DefinitionParoxysmal nocturnal hemoglobinuria (PNH): a complement‑mediated hemolytic anemia for which complement inhibitors such as Empaveli (pegcetacoplan) are indicated.

Indication (documented)Empaveli indicated for treatment of adult patients with PNH.

Related drug classComplement inhibitor (e.g., pegcetacoplan).

Authorization durationInitial and reauthorization approvals are issued for 12 months.

Therapeutic duplicationConcurrent use of Empaveli with another complement inhibitor for the same indication is excluded (requests may be denied).

Clinical response (C3G/IC‑MPGN) — reduction in proteinuria

Policy Summary

PayerUnitedHealthcare

PolicyEmpaveli (pegcetacoplan) prior authorization - Prior Authorization/Notification for PNH and C3G/IC-MPGN

Policy CodePolicy 1 = 2025 P 1361-7

Change TypeUpdated indicationsrevised authorization rules

Effective Date1/1/2026

Next Review Date

Key ActionSubmit documentation of confirmed diagnosis and for reauthorization provide evidence of positive clinical response (reduction in proteinuria for C3G/IC-MPGN).

SourceLink

On This Page

PNH reauthorization: Documentation of positive clinical response to Empaveli therapy AND patient is not receiving Empaveli in combination with another complement inhibitor for PNH. Authorization = 12 months.
C3G/IC‑MPGN reauthorization: Documentation of positive clinical response demonstrated by a reduction in proteinuria AND patient is not receiving Empaveli in combination with another complement inhibitor for C3G/IC‑MPGN. Authorization = 12 months.

Note

Automated / Claims-based Approvals

UnitedHealthcare may use automated or claims-based approvals for initial or continued authorization where prior medication/claim history, diagnosis codes (ICD‑10), or claim logic demonstrate eligibility. Availability of automated approval varies by program and therapeutic class.

Automated approval or reapproval can be based solely on prior claims/medication history, diagnosis codes, and/or claim logic.
Use of automated processes varies by program and therapeutic class; supply limits may still apply.

Documentation Required

Clinical Response Documentation

Document the patient’s clinical response to Empaveli at reauthorization. For PNH, provide evidence of clinical improvement per treating clinician (labs, transfusion requirements, symptom improvement). For C3G/IC‑MPGN, document reduction in proteinuria and other relevant renal parameters.

Include objective data when available (e.g., hemoglobin/LDH/transfusion records for PNH; urine protein quantification, serum creatinine, eGFR for C3G/IC‑MPGN).
Clinical notes should explicitly state treatment response and link the response to continued medical necessity for Empaveli.

Denial Risk

Therapeutic Duplication — Avoidance and Denial Risk

Therapeutic duplication — avoid approvals when Empaveli would be used concurrently with another complement inhibitor for the same indication. If switching from another complement inhibitor, document discontinuation of the prior agent and initiation per FDA labeling to avoid duplication denials.

Examples of other complement inhibitors: Bkemv, Epysqli, Fabhalta, PiaSky, Soliris, Ultomiris.
If a patient is switching therapies, include documentation that the prior complement inhibitor will be discontinued and that Empaveli initiation follows FDA‑approved guidance.

Note

Alternative Approval Pathways

Alternative approval pathways: UnitedHealthcare may consider approval based on previous authorization history, medical records, or program‑specific pathways where established (including state mandates and member benefit plan provisions).

State mandates and member‑specific benefit plan coverage may alter standard criteria — verify applicable regulatory and plan requirements.
Other policies and utilization management programs may apply and can provide alternative pathways to approval (e.g., prior authorizations accepted from another UnitedHealthcare program or documented prior approvals).
Supply limits and program-specific authorization rules may also affect approval decisions.

Clinical response measureReduction in proteinuria is the required demonstration of positive clinical response for reauthorization in C3G/IC‑MPGN.

Context of useApplies to reauthorization of Empaveli for C3 glomerulopathy (C3G) or primary immune‑complex membranoproliferative glomerulonephritis (IC‑MPGN).

Age group noted in policyIndication for C3G/IC‑MPGN applies to patients aged 12 years and older.

Therapeutic duplicationPatient must not be receiving Empaveli in combination with another complement inhibitor for C3G or IC‑MPGN at reauthorization.