VOYDEYA (danicopan)

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.