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Sevenfact — Blue Cross Blue Shield of Oklahoma

indications supported in compendia for the requested agent and route of administration

Initial criteria

  • For continuation of therapy: prescriber states the patient has been treated with the requested agent (not including samples) within the past 90 days AND patient is at risk if therapy is changed
  • For hemophilia A: patient has inhibitors to Factor VIII AND requested agent used for one of the following: (a) On-demand treatment AND (i) prescriber verified patient does not have >5 on-demand doses on hand OR (ii) support for >5 doses; OR (b) Prophylaxis AND (i) patient tried and had inadequate response to Immune Tolerance Induction (ITI) OR inhibitor ≥200 BU OR not candidate for ITI AND (ii) not used with Hemlibra; OR (c) Peri-operative management; OR (d) Component of ITI/ITT AND (i) <33 months of ITI/ITT OR (ii) documented ≥20% inhibitor reduction over last 6 months and further therapy needed.
  • For hemophilia B: patient has inhibitors to Factor IX AND requested agent used for one of the following: (a) On-demand treatment AND (i) prescriber verified patient does not have >5 on-demand doses on hand OR (ii) support for >5 doses; OR (b) Prophylaxis AND (i) inadequate response to ITI OR inhibitor ≥200 BU OR not candidate for ITI; OR (c) Peri-operative management; OR (d) Component of ITI/ITT AND (i) <33 months of therapy OR (ii) ≥20% inhibitor reduction over last 6 months and further therapy needed.
  • For congenital Factor VII deficiency: requested agent used for one of the following: (a) On-demand treatment AND (i) prescriber verified patient does not have >5 on-demand doses on hand OR (ii) support for >5 doses; OR (b) Prophylaxis; OR (c) Perioperative use.
  • For Glanzmann’s thrombasthenia: patient refractory to platelet transfusions AND use for one of: (a) On-demand treatment AND (i) prescriber verified patient does not have >5 on-demand doses on hand OR (ii) support for >5 doses; OR (b) Perioperative use.
  • For acquired hemophilia: use for one of the following: (a) On-demand treatment AND (i) prescriber verified patient does not have >5 on-demand doses on hand OR (ii) support for >5 doses; OR (b) Perioperative use.
  • For other covered indications: requested agent has FDA approved indication OR compendia-supported indication AND prescriber is a specialist in the diagnosis area or has consulted with one AND agent not used with another Factor VIIa AND no FDA-labeled contraindications.
  • Compendia recognized: AHFS, DrugDex level 1, 2a, or 2b.
  • Special Ohio fully insured/HIM Shop exception: member resides in Ohio AND plan is Fully Insured or HIM Shop AND no contraindications AND (a) FDA labeled indication OR (b) compendia-supported indication OR (c) prescriber has submitted two peer-reviewed articles showing safe/effective use.

Reauthorization criteria

  • Continuation of therapy allowed if patient has been treated with the requested agent within the past 90 days and is at risk if therapy is changed.
  • For ITI/ITT continuation, patient has had ≥20% decrease in inhibitor level over last 6 months and needs further treatment.

Approval duration

Peri-operative: 1 time; On-demand: up to 3 months; Prophylaxis: up to 12 months; ITI/ITT: up to 6 months (≤33 total months); other indications: up to 3 months; BCBSIL/BCBSTX: 12 months; BCBSMT/BCBSNM: prophylaxis 12 months, other indications 3 months