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).

Criteria

Empaveli

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• 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)

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

P & T Revisions

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. February 2024.
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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Revision History

• 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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