Beqvez™
Drugs - Beqvez™ (fidanacogene elaparvovec-dzkt) [Pfizer Inc.]
January 2025
Therapeutic area - Hemophilia Treatment
Approval criteria
- Patient has a diagnosis of congenital hemophilia B (also known as Factor IX deficiency, Christmas disease) AND
- Patient is 18 years of age or over AND
- Patient has been screened for Factor IX inhibitor titers AND ONE of the following: (medical records required)
- Patient tested negative for Factor IX inhibitor titers on the initial screening OR
- BOTH of the following:
- Patient tested positive for Factor IX inhibitors on the initial screening AND
- Patient tested negative for Factor IX inhibitors within 2 weeks of initial screening AND
- ONE of the following: (medical records required)
- Patient is on prophylactic therapy with a Factor IX agent (e.g., AlphaNine SD,Alprolix, BeneFIX, Idelvion, Ixinity, Mononine, Profilnine SD, Rebinyn, Rixubis) OR
- Patient has current or historical life-threatening hemorrhage OR
- Patient has had repeated, serious spontaneous bleeding episodes AND
- Prescriber has evaluated the patient's liver function and determined the patient has adequate liver function to receive the requested agent based on the following assessments:
- Liver enzyme testing (i.e., alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], total bilirubin) AND
- Hepatic ultrasound and elastography AND
- If patient has sustained liver enzyme elevations and/or radiological liver abnormalities, the prescriber has considered consultation with a specialist (i.e., hepatologist) AND
- Patient has NOT had any previous gene therapy (including requested agent)
Quantity limits
- 1 kit and may not be renewed
Billing for Beqvez
Beqvez must be billed as a medical claim
Questions?
Provider Call Center 844-575-7887