WHA

EMPAVELI (pegcetacoplan)

Self-Administration - subcutaneous via infusion pump

Indications for Prior Authorization:
  • Paroxysmal Nocturnal Hemoglobinuria (PNH): Indicated for the treatment of adult patients with PNH.
Coverage Criteria:

For diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH):

  • Dose does not exceed 1,080 mg twice weekly given subcutaneously via infusion pump; AND
  • Patient is 18 years of age or older; AND
  • Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH) is confirmed by medical records
Reauthorization Criteria:

For diagnosis of PNH:

  • Dose does not exceed 1,080 mg twice weekly given subcutaneously via infusion pump; AND
  • Documentation of positive clinical response to therapy (e.g., improvement in hemoglobin level, hemoglobin stabilization, decrease in the number of red blood cell transfusions).
Coverage Duration:
  • Initial: 1 year
  • Reauthorization: 1 year
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Policy Updates:
  • 11/16/2021 – New policy approved by P&T.
  • 06/02/2022 - Updated status to office administered with prior authorization due to administration via an infusion pump.
  • 09/02/2023 - Change status back to self-administered with prior authorization, specialty pharmacy distribution, and 30-day limit per copayment. 
  • 12/01/2023 (policy effective date) – Removal of trial and failure of Ultomiris (ravulizumab) (P&T meeting, 11/14/2023)
References:
  1. Empaveli Prescribing Information. Apellis Pharmaceuticals, Inc. Waltham, MA. May 2021.
  2. 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.
  3. Hillmen P, et al. “Pegcetacoplan versus Eculizumab in Paroxysmal Nocturnal Hemoglobinuria.” New England Journal of Medicine, vol. 384, no. 11, 2021, pp. 1028–1037.
  4. Empaveli. IBM Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Accessed October 4, 2023. http://www.micromedexsolutions.com.

Last review date: December 1, 2023