NovoSeven RT — Blue Cross Blue Shield of Illinois
other FDA-approved or compendia-supported indications for coagulation factor VIIa
Initial criteria
- ONE of the following:
- • Continuation of therapy: patient has been treated with the requested agent (not samples) within the past 90 days and is at risk if therapy is changed
- • For hemophilia A: patient has inhibitors to Factor VIII AND use for one of the following:
- – On-demand bleeds: prescriber verified patient does not have greater than 5 doses on hand OR support for more than 5 doses
- – Prophylaxis: patient tried and had inadequate response to Immune Tolerance Induction (ITI)/Therapy (ITT) OR inhibitor level ≥ 200 BU (lab records required) OR not a candidate for ITI; patient will NOT use in combination with Hemlibra
- – Peri-operative management of bleeding
- – As component of ITI/ITT therapy and patient has NOT had more than 33 months of ITI/ITT therapy OR support of continued use (≥20% inhibitor decrease over last 6 months)
- • For hemophilia B: patient has inhibitors to Factor IX AND same use categories as hemophilia A
- • For congenital Factor VII deficiency: use for on-demand bleeds (≤5 or supported >5 doses) OR prophylaxis OR perioperative use
- • For Glanzmann’s thrombasthenia: refractory to platelet transfusions AND use for on-demand bleeds (≤5 or supported >5 doses) OR perioperative use
- • For acquired hemophilia: use for on-demand bleeds (≤5 or supported >5 doses) OR perioperative use
- • For FDA-approved or compendia-supported indications: prescriber specialist in hemophilia or consulted specialist; not used with another Factor VIIa; no contraindications
- • Compendia allowed: AHFS or DrugDex 1, 2a, or 2b level of evidence
Reauthorization criteria
- Continuation of therapy approvable if prescriber states patient has been treated with requested agent within past 90 days and is at risk if therapy is changed
- For ITI/ITT continuation: patient shows ≥20% inhibitor decrease over last 6 months or other support for continued use
Approval duration
Peri-operative: 1-time; On-demand: up to 3 months; Prophylaxis: up to 12 months; ITI/ITT: up to 6 months (max 33 months total); other indications: 3 months; BCBSIL/BCBSTX: 12 months; BCBSMT/BCBSNM: 12 months for prophylaxis, 3 months others