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:
- Voydeya Prescribing Information. Alexion Pharmaceuticals, Inc. Boston, MA. March 2024.
Last review date: September 1, 2024