Sevenfact — Blue Cross Blue Shield of Montana

Initial criteria

• ONE of the following:
• A. The requested agent is eligible for continuation of therapy AND prescriber states the patient has been treated with the requested agent within the past 90 days AND is at risk if therapy is changed OR
• B. BOTH of the following:
• 1. ONE of the following:
• A. hemophilia A with inhibitors to Factor VIII AND requested agent used for ONE of:
• • On-demand use for bleeds AND prescriber verified patient does not have >5 doses on hand OR support for >5 doses on hand
• • Prophylaxis AND patient tried and had inadequate response to Immune Tolerance Induction (ITI)/Immune Tolerance Therapy (ITT) OR inhibitor level ≥200 BU OR not a candidate for ITI AND will NOT use requested agent with Hemlibra
• • Peri-operative management of bleeding
• • Component of Immune tolerance induction (ITI)/Immune tolerance therapy (ITT) AND patient has NOT had >33 months of therapy OR ≥20% decrease in inhibitor level over last 6 months and needs further treatment (medical records required)
• B. hemophilia B with inhibitors to Factor IX AND requested agent used for ONE of:
• • On-demand use for bleeds AND prescriber verified patient does not have >5 doses on hand OR support for >5 doses on hand
• • Prophylaxis AND tried and had inadequate response to ITI/ITT OR inhibitor level ≥200 BU OR not a candidate for ITI
• • Peri-operative management of bleeding
• • Component of ITI/ITT AND NOT >33 months of therapy OR ≥20% decrease in inhibitor level over 6 months (medical records required)
• C. congenital Factor VII deficiency AND requested agent used for ONE of:
• • On-demand use for bleeds AND prescriber verified patient does not have >5 doses on hand OR support for >5 doses on hand
• • Prophylaxis
• • Perioperative use
• D. Glanzmann’s thrombasthenia refractory to platelet transfusions AND requested agent used for ONE of:
• • On-demand use for bleeds AND prescriber verified patient does not have >5 doses on hand OR support for >5 doses on hand
• • Perioperative use
• E. acquired hemophilia AND requested agent used for ONE of:
• • On-demand use for bleeds AND prescriber verified patient does not have >5 doses on hand OR support for >5 doses on hand
• • Perioperative use
• F. another FDA approved indication AND patient age within labeling OR supported for use for patient's age OR indication supported in compendia for requested agent and route of administration AND prescriber is a specialist or consulted with specialist AND patient will NOT use another Factor VIIa agent AND patient does NOT have contraindications
• Compendia Allowed: AHFS, or DrugDex 1, 2a, or 2b level of evidence
• The requested agent will also be approved when:
• • Member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND patient does NOT have contraindications AND ONE of:
• – Patient has another FDA labeled indication OR compendia-supported indication OR prescriber submitted two peer-reviewed articles supporting proposed use

Approval duration

Prophylaxis: 12 months; all other indications: 3 months