Xyntha (antihemophilic factor [recombinant]) — United Healthcare
hemophilia A (congenital Factor VIII deficiency)
Preferred products
- Advate
- Kogenate FS
- Kovaltry
- NovoEight
- Nuwiq
- Recombinate
Initial criteria
- Diagnosis of hemophilia A
- AND one of the following:
- 1. Submission of documentation showing failure to meet clinical goals (e.g., continuation of spontaneous bleeds, inability to achieve appropriate trough level) after a trial of three of the following recombinant factor products: Advate, Kogenate FS, Kovaltry, NovoEight, Nuwiq, Recombinate
- OR 2. Submission of documentation showing history of hypersensitivity to three of the following recombinant factor products: Advate, Kogenate FS, Kovaltry, NovoEight, Nuwiq, Recombinate
- OR 3. Prescriber attestation that patient would preferentially benefit from Xyntha based on one of the following: patient is at high risk for the development of inhibitors (e.g., family history of inhibitors and success with product, current treatment less than 50 days, high risk genetic mutation, history of initial intensive therapy greater than 5 days), patient has developed inhibitors, or patient has undergone immune tolerance induction/immune tolerance therapy
Reauthorization criteria
- Documentation of positive clinical response to Xyntha therapy
Approval duration
12 months