Pharmacy Prior Authorization Criteria

Empaveli (pegcetacoplan)

Indications for Prior Authorization

Empaveli (pegcetacoplan)

• For diagnosis of Paroxysmal Nocturnal Hemoglobinuria
  Indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

• For diagnosis of C3 Glomerulopathy or Primary Immune-Complex Membranoproliferative Glomerulonephritis
  Indicated for the treatment of adult and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce proteinuria.

Criteria

Empaveli

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Paroxysmal nocturnal hemoglobinuria (PNH)

• Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH)
AND
• Prescribed by or in consultation with one of the following:
• Hematologist
• Oncologist

Empaveli

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Paroxysmal nocturnal hemoglobinuria (PNH)

• Patient demonstrates positive clinical response to therapy (e.g., improvement in hemoglobin level, hemoglobin stabilization, decrease in the number of red blood cell transfusions)

Empaveli

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Complement 3 Glomerulopathy or Primary Immune-Complex Membranoproliferative Glomerulonephritis

• One of the following diagnoses:
• Complement 3 glomerulopathy (C3G)
• Primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN)
AND
• For primary immune-complex membranoproliferative glomerulonephritis, patient has not had a kidney transplant [A]
AND
• Used to reduce proteinuria
AND
• Patient is 12 years of age or older
AND
• Patient is currently being treated with a maximally tolerated dose of one of the following for at least 12 weeks prior to initiating treatment:
• Angiotensin-converting enzyme inhibitors (e.g., benazepril, lisinopril)
• Angiotensin receptor blockers (e.g., losartan, valsartan)
• Sodium-glucose cotransporter-2 (SGLT2) inhibitors (e.g., Farxiga [dapagliflozin] Jardiance [empagliflozin])
AND
• Prescribed by or in consultation with nephrologist

Empaveli

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Complement 3 Glomerulopathy or Primary Immune-Complex Membranoproliferative Glomerulonephritis

• Patient demonstrates positive clinical response to therapy (e.g., reduction in UPCR, stable or improved eGFR compared to baseline)
AND
• For primary immune-complex membranoproliferative glomerulonephritis, patient has not had a kidney transplant [A]
AND
• Patient continues to be treated with a maximally tolerated dose of one of the following:
• Angiotensin-converting enzyme inhibitors (e.g., benazepril, lisinopril)
• Angiotensin receptor blockers (e.g., losartan, valsartan)
• Sodium-glucose cotransporter-2 (SGLT2) inhibitors (e.g., Farxiga [dapagliflozin] Jardiance [empagliflozin])

P & T Revisions

2025-09-04, 2024-06-03, 2024-04-03, 2023-09-29, 2023-06-22, 2022-10-06, 2021-09-20, 2021-06-18

References

1. Empaveli Prescribing Information. Apellis Pharmaceuticals, Inc. Waltham, MA. July 2025.
2. Per clinical consultation with specialist, June 18, 2021.
3. Kulasekararaj AG., et al. “Ravulizumab (ALXN1210) vs Eculizumab in C5-Inhibitor–Experienced Adult Patients with PNH: the 302 Study.” Blood, vol. 133, no. 6, 2019, pp. 540–549.
4. Hillmen P, et al. “Pegcetacoplan versus Eculizumab in Paroxysmal Nocturnal Hemoglobinuria.” New England Journal of Medicine, vol. 384, no. 11, 2021, pp. 1028–1037.

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End Notes

1. Safety and effectiveness of EMPVAELI in patients with recurrent IC-MPGN following kidney transplant have not been established. [1]

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Revision History

• 2025-09-04: 2025 Annual Review. New indication. Updated references.
• 2024-06-03: 2024 UM Annual Review. No criteria changes. Background updates
• 2024-04-03: Added specialist prescriber requirement.
• 2023-09-29: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-06-22: 2023 UM Annual Review. No criteria changes. Updated references
• 2022-10-06: GPI Reclassification
• 2021-09-20: Removed trial and failure requirement through Ultomiris due to formulary strategy.
• 2021-06-18: New program.

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