VOYDEYA (danicopan)

Self-Administration – oral tablets

Diagnosis considered for coverage:
  • Paroxysmal nocturnal hemoglobinuria (PNH): Indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH).
  • Limitations of Use:
    • Voydeya has not been shown to be effective as monotherapy and should only be prescribed as an add-on to ravulizumab or eculizumab
Coverage Criteria:

For diagnosis of PNH:

  • Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH); AND
  • Will be used as add-on therapy to Ultomiris (ravulizumab) or Soliris (eculizumab); AND
  • Hemoglobin levels less than or equal to 9.5 g/dL; AND
  • Absolute reticulocyte count greater than or equal to 120 × 10^9 /L; AND
  • Prescribed by or in consultation with a hematologist/oncologist
Reauthorization Criteria:

For diagnosis of PNH:

  • Patient demonstrates positive clinical response to therapy (e.g., hemoglobin stabilization, decrease in the number of red blood cell transfusions); AND
  • Will be used as add-on therapy to Ultomiris (ravulizumab) or Soliris (eculizumab)
Coverage Duration:
  • Initial: 1 year
  • Reauthorization: 1 year
Dosing:

For diagnosis of PNH:

  • Recommended dose: 150 mg three times a day
  • The dose can be increased to 200 mg three times a day if the patient's hemoglobin (Hgb) level has not increased by greater than 2 g/dL after 4 weeks of therapy, if the patient required a transfusion during the previous 4 weeks, or to achieve an appropriate Hgb response based on clinical judgement
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.

Additional Information:
  • Healthcare professionals who prescribe Voydeya must enroll in the Voydeya REMS
  • Voydeya is contraindicated for initiation in patients with unresolved serious infection caused by encapsulated bacteria, including Neisseria meningitidis, Streptococcus pneumoniae, or Haemophilus influenzae type B
Policy Updates:
  • 9/1/2024 (policy effective date) – New policy approved by WHA P&T Committee. (P&T, 8/20/2024) (P&T meeting date) 
References:
  1. Voydeya Prescribing Information. Alexion Pharmaceuticals, Inc. Boston, MA. March 2024.

Last review date: September 1, 2024

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