Sevenfact — Blue Cross Blue Shield of Texas

Initial criteria

• ONE of the following:
• A. Continuation of therapy: The prescriber states the patient has been treated with the requested agent (not started on samples) within the past 90 days and is at risk if therapy is changed.
• OR
• B. New start of therapy meeting disease-specific conditions:
• 1. Hemophilia A AND the patient has inhibitors to Factor VIII AND the requested agent used for one of the following:
• - On-demand bleeds AND prescriber verified patient does not have >5 on-demand doses on hand OR supports >5 doses.
• - Prophylaxis AND patient tried and had inadequate response to Immune Tolerance Induction (ITI) OR inhibitor level ≥200 BU (lab records required) OR patient not candidate for ITI AND patient will NOT use in combination with Hemlibra.
• - Peri-operative management of bleeding.
• - Component of ITI/ITT AND (patient has not had >33 months of therapy OR there is documentation of ≥20% decrease in inhibitor level over last 6 months needing further treatment).
• 2. Hemophilia B AND the patient has inhibitors to Factor IX AND same usage conditions (on-demand, prophylaxis, peri-operative, or ITI/ITT per above).
• 3. Congenital Factor VII deficiency AND requested agent used for on-demand, prophylaxis, or perioperative use with same dose supply verification.
• 4. Glanzmann’s thrombasthenia refractory to platelet transfusions AND used on-demand or perioperative (with same dose supply verification).
• 5. Acquired hemophilia AND requested agent used on-demand (with dose verification) or perioperative.
• 6. Other FDA approved indication and route (and patient age within labeling OR supported by data) OR other compendia-supported indication for this agent and route.
• Additional required criteria:
• - Prescriber is a specialist in or consulting with a specialist in the area of the diagnosis (e.g., hematologist or HTC).
• - Patient will NOT use in combination with another Factor VIIa agent.
• - No FDA labeled contraindications to the requested agent.
• Compendia accepted: AHFS or DrugDex level 1, 2a, or 2b.

Reauthorization criteria

• Continuation of therapy allowed if patient meets continuation definition (prescriber attests use within 90 days and patient at risk if changed) and continues to meet diagnosis criteria as above.

Approval duration

3–12 months depending on indication (Prophylaxis: 12 months; On-demand and other: 3 months; ITI/ITT: 6 months up to 33 months total; Peri-operative: 1 time per request).