Qfitlia — Highmark
Hemophilia A
Initial criteria
- age ≥ 12 years
- Diagnosis of Hemophilia A (ICD-10: D66) AND prescriber documents severe disease (< 1% of normal factor activity) OR Diagnosis of Hemophilia B (ICD-10: D67) AND prescriber documents moderately severe to severe disease (≤ 2% of normal factor activity)
- Using the product for routine prophylaxis
- EITHER documented history of FVIII or FIX inhibitors (≥ 0.6 Bethesda units/mL) OR no documented history of inhibitors AND previously taken a factor VIII or IX replacement therapy (for example, Adynovate, Advate, Afstyla, Altuviiio, etc.)
- Documentation of antithrombin (AT) activity > 60% prior to treatment initiation and planned monitoring with AT activity to adjust dose using an FDA-cleared test
Reauthorization criteria
- Prescriber attests member is tolerating therapy and has experienced a therapeutic response defined as disease stability, disease improvement, or delayed disease progression
- Prescriber submits AT activity documentation AND EITHER AT activity 15%-35% OR AT activity < 15% with member undergoing dose reduction OR AT activity > 35% with member undergoing dose escalation
Approval duration
initial 6 months; reauthorization 12 months