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Complement Inhibitors - Empaveli
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Defines Cigna's prior authorization, coverage criteria, and clinical context for Empaveli (pegcetacoplan) for C3 glomerulopathy, primary immune-complex membranoproliferative glomerulonephritis, and paroxysmal nocturnal hemoglobinuria; applies to health benefit plans administered by Cigna Companies.
Conditions Not Covered: Voydeya was added to the list of medications that should not be used concomitantly with Empaveli.
For patients currently receiving Empaveli, examples of benefit were updated to include improvement in FACIT‑Fatigue score.
Biosimilars to Soliris (eculizumab) were added to criteria addressing concomitant use and Conditions Not Covered.
Complement 3 Glomerulopathy (C3G) was added as an FDA-approved indication to the policy with documentation required.
PiaSky (crovalimab-akkz) was added to the list of medications that should not be used concomitantly with Empaveli.
Documentation requirements for confirmation of diagnosis were added.
Coverage Criteria for Empaveli (pegcetacoplan)
Complement 3 Glomerulopathy (C3G)
Empaveli is considered medically necessary when the following are met for Complement 3 Glomerulopathy (approve durations noted).
C3G Indication
A) Initial therapy
- Age: Patient is ≥ 12 years of age
- Diagnosis confirmed by biopsy [documentation required]
- Proteinuria: Urine protein-to-creatinine ratio ≥ 1.0 g/g
- Renal function: Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2
- Background therapy: On stable doses of at least ONE of the following for ≥ 12 weeks prior to starting Empaveli: ACE inhibitor, ARB, or SGLT2 inhibitor
- Prescriber: Prescribed by or in consultation with a nephrologist
B) Currently receiving Empaveli
- Age: Patient is ≥ 12 years of age
- Diagnosis confirmed by biopsy [documentation required]
- Response: According to the prescriber, patient has had a response to Empaveli (e.g., reduction in UPCR/proteinuria)
Examples include reduction in urine-to-creatinine ratio or reduction in proteinuria from baseline.
- Renal function: Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2
- Prescriber: Prescribed by or in consultation with a nephrologist
Immune‑Complex MPGN (IC‑MPGN)
Immune‑Complex Membranoproliferative Glomerulonephritis, Primary (approve durations noted).
IC‑MPGN Indication
A) Initial therapy
- Age: Patient is ≥ 12 years of age
- Diagnosis confirmed by biopsy [documentation required]
- Proteinuria: Urine protein-to-creatinine ratio ≥ 1.0 g/g
- Renal function: Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2
- Background therapy: On stable doses of at least ONE of the following for ≥ 12 weeks prior to starting Empaveli: ACE inhibitor, ARB, or SGLT2 inhibitor
- Prescriber: Prescribed by or in consultation with a nephrologist
B) Currently receiving Empaveli
- Age: Patient is ≥ 12 years of age
- Diagnosis confirmed by biopsy [documentation required]
- Response: According to the prescriber, patient has had a response to Empaveli (e.g., reduction in UPCR/proteinuria)
Examples include reduction in urine-to-creatinine ratio or reduction in proteinuria from baseline.
- Renal function: Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2
- Prescriber: Prescribed by or in consultation with a nephrologist
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Paroxysmal Nocturnal Hemoglobinuria (PNH).
PNH Indication
A) Initial therapy
- Age: Patient is ≥ 18 years of age
- Diagnosis confirmed by peripheral blood flow cytometry showing absence/deficiency of GPI‑anchored proteins on at least two cell lineages [documentation required]
- Transition from eculizumab: If transitioning from eculizumab IV, prescriber attests eculizumab will be discontinued 4 weeks after starting Empaveli
Empaveli may be initiated while continuing eculizumab for a transition period of up to 4 weeks.
- Prescriber: Prescribed by or in consultation with a hematologist
B) Currently receiving Empaveli
- Age: Patient is ≥ 18 years of age
- Ongoing benefit: Patient is continuing to derive benefit from Empaveli per prescriber (e.g., hemoglobin stabilization/increase, decreased transfusion requirements, reductions in hemolysis, improved FACIT‑Fatigue)
Examples of benefit include increase or stabilization of hemoglobin, reduced transfusion needs, reductions in hemolysis, or improvement in FACIT‑Fatigue score.
- Prescriber: Prescribed by or in consultation with a hematologist
Conditions Not Covered
Empaveli is considered not medically necessary when used concomitantly with the following; this list may not be all inclusive:
Empaveli may be initiated while continuing eculizumab to cover a transition period of up to 4 weeks; after 4 weeks eculizumab should be discontinued.
Empaveli (pegcetacoplan) is not medically necessary when used for any indication not specifically listed in this policy. In addition, concomitant use of Empaveli with certain complement inhibitors is considered not medically necessary as detailed below; the list may not be all‑inclusive and will be updated as evidence evolves.
Empaveli should not be used concomitantly with other complement inhibitors except as described for a limited transition from eculizumab. Specifically, concomitant use with eculizumab (Soliris) or its biosimilars beyond 4 weeks is considered not medically necessary. To reduce hemolysis risk when switching from eculizumab to Empaveli, a patient may be started on Empaveli while continuing eculizumab for a maximum 4‑week transition period; after 4 weeks eculizumab (or biosimilar) must be discontinued. Concomitant use with Fabhalta (iptacopan), PiaSky (crovalimab‑akkz), Ultomiris (ravulizumab‑cwvz), or Voydeya (danicopan) is also considered not medically necessary.
Use of Empaveli for any purpose not specified in the FDA‑approved indications and corresponding coverage criteria in this policy is considered not medically necessary and is not supported for benefit coverage.
Concomitant administration of Empaveli with other complement inhibitors is explicitly excluded. This includes continued combination therapy with eculizumab (Soliris) or its biosimilars beyond the allowed transition period and combination use with Fabhalta, PiaSky, Ultomiris, or Voydeya. These combinations are listed as not medically necessary and may be denied.
When considering transition from eculizumab to Empaveli, prescribers may overlap therapies only to cover a short transition: Empaveli may be initiated while continuing eculizumab (or a biosimilar) for up to 4 weeks, after which eculizumab must be stopped. Concomitant use of Empaveli with other listed complement inhibitors (Fabhalta, PiaSky, Ultomiris, Voydeya) is not supported by the evidence and is considered not medically necessary.
Coding, Thresholds, and Patient Criteria
Prior Authorization, Documentation, and Provider Requirements
Prior authorization required; specialist prescribing
Prior authorization is required for Empaveli. Approvals are provided for the durations noted in the criteria and Empaveli must be prescribed by or in consultation with a specialist in the treated condition (nephrologist for glomerular indications; hematologist for PNH). Documentation is required where noted in the criteria.
- Prior authorization required for benefit coverage of Empaveli.
- Prescribed by or in consultation with a specialist in the condition being treated (nephrologist or hematologist).
- Documentation required where noted in the criteria.
Approval durations — 6 months initial, 1 year continuation
Initial approvals for new therapy are for 6 months for C3G, IC‑MPGN, and PNH when initial criteria are met. Patients currently receiving Empaveli may be approved for 1 year if prescriber documents ongoing response or benefit.
- Initial therapy approvals: 6 months (C3G, IC‑MPGN, PNH).
- Continuation/currently receiving approvals: 1 year if prescriber documents response/benefit.
Submit diagnostic documentation and evidence of benefit (e.g., FACIT‑Fatigue)
Include documentation confirming the diagnosis and evidence of clinical benefit when submitting prior authorization; examples of benefit for continuing PNH therapy now explicitly list improvement in FACIT‑Fatigue score.
- Documentation may include chart notes, lab tests, claims records and must include patient identifiers.
- For continuing PNH therapy, examples of benefit include hemoglobin stabilization/increase, decreased transfusion requirements, reductions in hemolysis, or improved FACIT‑Fatigue score.
Background therapy required before initiating Empaveli for glomerular indications
For initial therapy in C3G and IC‑MPGN, patient must have been on stable doses of at least one of: an ACE inhibitor, an ARB, or an SGLT2 inhibitor for ≥ 12 weeks prior to starting Empaveli.
- Required background therapy: ACE inhibitor OR angiotensin receptor blocker OR SGLT2 inhibitor.
- Must be on a stable dose for at least 12 weeks before initiation of Empaveli.
Transitioning from eculizumab — up to 4‑week overlap only
When transitioning from eculizumab (Soliris or biosimilar) to Empaveli, Empaveli may be initiated while continuing eculizumab for up to 4 weeks to reduce hemolysis risk; eculizumab should be discontinued after 4 weeks.
- Prescriber must attest that eculizumab will be discontinued 4 weeks after starting Empaveli.
- Concomitant use of eculizumab beyond 4 weeks is considered not medically necessary.
Required documentation: biopsy, transplant recurrence, and PNH confirmation
Provide required diagnostic documentation as noted: biopsy confirmation for glomerular diagnoses and transplant recurrence; peripheral blood flow cytometry showing absence/deficiency of GPI‑anchored proteins on ≥ two lineages for PNH. Documentation must include patient identifiers and may include chart notes, labs, and claims.
- Glomerular indications: biopsy confirmation [documentation required].
- PNH: peripheral blood flow cytometry demonstrating absence/deficiency of GPI‑anchored proteins on at least two cell lineages [documentation required].
- Documentation may include chart notes, laboratory tests, claims records and must include patient‑specific identifiers.
Diagnosis confirmation required for newly added indications (C3G)
For newly added indications (e.g., Complement 3 Glomerulopathy), providers must supply supporting diagnostic documentation when requesting coverage; the policy explicitly added [documentation required] to the C3G indication.
- C3G indication requires biopsy confirmation with documentation supplied at prior authorization.
- Documentation confirming diagnosis is required for indications added to the policy.
Denial risk — not medically necessary uses and concomitant‑use exclusions
Use of Empaveli for any purpose not listed in the policy is considered not medically necessary. Concomitant use with certain complement inhibitors is explicitly listed as not covered and may result in denial.
- Empaveli for any other use not specified in the policy is considered not medically necessary.
- Concomitant use with listed complement inhibitors or prolonged overlap with eculizumab may be denied.
Concomitant therapy exclusions — specific agents that exclude coverage
Coverage will be considered not medically necessary for Empaveli used concomitantly with listed therapies: eculizumab (Soliris) or its biosimilars beyond 4 weeks, Fabhalta (iptacopan), PiaSky (crovalimab‑akkz), Ultomiris (ravulizumab‑cwvz), or Voydeya (danicopan).
- Concomitant eculizumab (Soliris) or biosimilars for > 4 weeks is not covered — overlap limited to 4 weeks for transition.
- Concomitant use with Fabhalta (iptacopan), PiaSky (crovalimab‑akkz), Ultomiris (ravulizumab‑cwvz), or Voydeya (danicopan) is not covered.
Background and Clinical Context
Complement 3 glomerulopathy (C3G) and immune‑complex membranoproliferative glomerulonephritis (IC‑MPGN) are rare, chronic complement‑mediated kidney diseases characterized by glomerular deposition of complement factors and/or immune complexes. Dysregulation of the complement pathway is central to disease pathogenesis, and both disorders carry a risk of progressive kidney injury and eventual kidney failure. Diagnosis typically requires kidney biopsy confirmation and clinical assessment of proteinuria and renal function; these findings guide treatment decisions including initiation of targeted complement inhibitors such as Empaveli.
Definitions and Measurement Tools
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