Sevenfact — Blue Cross Blue Shield of New Mexico

Initial criteria

• 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.
• Hemophilia A: Patient has inhibitors to Factor VIII AND use is for one of the following: (a) On-demand use for bleeds AND prescriber verified the patient does not have more than 5 on-demand doses on hand OR has support for more; OR (b) Prophylaxis AND (i) tried and inadequate response to Immune Tolerance Induction (ITI)/Immune Tolerance Therapy (ITT) OR inhibitor level ≥200 BU OR not a candidate for ITI, AND patient will NOT be using with Hemlibra; OR (c) Peri-operative management of bleeding; OR (d) As a component of ITI/ITT AND ≤33 months therapy OR continued use supported by ≥20% inhibitor level decrease over last 6 months.
• Hemophilia B: Patient has inhibitors to Factor IX AND use is for one of the following: (a) On-demand bleeds with prescriber verification or supporting rationale for >5 doses; OR (b) Prophylaxis AND (i) inadequate response to ITI/ITT OR inhibitor level ≥200 BU OR not a candidate for ITI; OR (c) Peri-operative management; OR (d) As a component of ITI/ITT as above.
• Congenital Factor VII deficiency: Use for one of the following: on-demand bleeds (with prescriber verification of ≤5 on-demand doses or support for >5), prophylaxis, or perioperative use.
• Glanzmann’s thrombasthenia: Patient is refractory to platelet transfusions AND use for on-demand bleeds (with prescriber verification or support for >5 doses) OR perioperative use.
• Acquired hemophilia: Use for on-demand bleeds (as above) or perioperative use.
• Other FDA-approved or compendia-supported indications allowed when prescriber is a specialist in hematology or consulted one AND patient will NOT use with another Factor VIIa agent AND has no contraindications.
• Compendia allowed evidence: AHFS or DrugDex 1, 2a, or 2b level.

Reauthorization criteria

• Continuation of therapy eligible for approval 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 use, continued approval if patient has had at least a 20% decrease in inhibitor level over prior 6 months and needs further treatment to eradicate inhibitors.

Approval duration

3-12 months depending on indication and plan