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SevenfactBlue Cross Blue Shield of New Mexico

Other FDA-approved indications for the requested agent and route of administration

Initial criteria

  • ONE of the following:
  • A. The requested agent is eligible for continuation of therapy AND the following:
  • • The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) 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. The patient has a diagnosis of hemophilia A AND BOTH of the following:
  • • The patient has inhibitors to Factor VIII AND
  • • The requested agent is being used for on-demand use for bleeds
  • OR
  • B. The patient has a diagnosis of hemophilia B AND BOTH of the following:
  • • The patient has inhibitors to Factor IX AND
  • • The requested agent is being used for on-demand use for bleeds
  • OR
  • C. The patient has another FDA approved indication for the requested agent and route of administration
  • AND
  • 2. If the patient has an FDA labeled indication, then ONE of the following:
  • A. The patient's age is within FDA labeling for the requested indication for the requested agent
  • OR
  • B. There is support for using the requested agent for the patient's age for the requested indication
  • AND
  • 3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., prescriber working in a hemophilia treatment center, hematologist with hemophilia experience) or has consulted with a specialist in the area of the patient’s diagnosis
  • AND
  • 4. The patient will NOT be using the requested agent in combination with another Factor VIIa agent
  • AND
  • 5. The patient does NOT have any FDA labeled contraindications to the requested agent
  • AND
  • 6. ONE of the following:
  • A. The prescriber has verified that the patient does not have greater than 5 on-demand doses on hand
  • OR
  • B. There is support for the patient having more than 5 on-demand doses on hand

Reauthorization criteria

  • Continuation of therapy may be approved if the prescriber confirms ongoing use of the requested agent within the past 90 days and the patient remains at risk if therapy is changed

Approval duration

12 months