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Xyntha — Blue Cross Blue Shield of Oklahoma

hemophilia A (Factor VIII deficiency)

Initial criteria

  • One of the following: (A) The requested agent is eligible for continuation of therapy AND the 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. The patient has a diagnosis of hemophilia A AND one of the following:
  • 1. The patient is currently experiencing a bleed AND both (A) patient is out of medication AND (B) needs to receive a one-time emergency supply OR
  • 2. All of the following: (A) requested agent is FDA labeled or compendia supported for hemophilia A AND (B) requested agent used for one of: (1) Prophylaxis and the patient will NOT use in combination with Hemlibra (emicizumab-kxwh) OR (2) as component of Immune Tolerance Therapy (ITT)/Immune Tolerance Induction (ITI) where patient will NOT use in combination with Hemlibra AND one of: (A) patient has NOT had more than 33 months ITT/ITI therapy OR (B) there is support for continued use of ITT/ITI (≥20% inhibitor decrease in last 6 months and needs further eradication) OR (3) On-demand use for bleeds OR (4) Peri-operative management of bleeding.
  • B. The patient has a diagnosis of von Willebrand disease (VWD) AND all of the following: (1) requested agent is FDA labeled or compendia supported for VWD AND (2) one of:
  • A. Patient is experiencing a bleed AND both patient is out of medication AND needs a one-time emergency supply OR
  • B. Patient has type 1, 2A, 2M, or 2N VWD AND one of: inadequate response to desmopressin (DDAVP/Stimate), no response on DDAVP trial (1 and 4 hr post infusion), intolerance or hypersensitivity, FDA contraindication, or inability to use desmopressin (e.g. shortage) OR
  • C. Patient has type 2B or 3 VWD; AND requested agent used for one of: (A) prophylaxis if Vonvendi (for severe type 3 VWD or subtype FDA labeled for prophylaxis) OR (B) On-demand use for bleeds OR (C) Peri-operative management of bleeding.
  • If patient has an FDA labeled indication, then one of: (A) age is within FDA labeling OR (B) there is support for use by age.
  • Prescriber is a specialist in area (hemophilia treatment center, hematologist) or has consulted a specialist.
  • Patient has no FDA labeled contraindications.
  • Prescriber must provide prescribed dose with patient’s weight, intended use/regimen, severity and inhibitor status if hemophilia A.
  • Patient will NOT use requested agent in combination with another agent in same category unless there is support for doing so (medical records required).
  • Compendia allowed: AHFS or DrugDex 1,2a,2b evidence levels.

Reauthorization criteria

  • Patient previously approved for requested agent (if only for one-time emergency use, must use initial criteria).
  • If using for prophylaxis: (A) for hemophilia A, patient will NOT use in combination with Hemlibra OR (B) patient has another diagnosis.
  • Prescriber is a specialist or consulted a specialist in area of diagnosis.
  • Patient has no FDA labeled contraindications.
  • Prescriber provides dose with patient’s weight, intended use/regimen, and if hemophilia A, severity and inhibitor status.
  • Prescriber confirms frequency and severity of bleeds and verifies patient does not have >5 on-demand doses on hand OR provides support for having more.
  • Patient will NOT use requested agent in combination with another agent in same category unless justified by medical records.
  • If on ITT/ITI: patient will NOT use in combination with Hemlibra AND one of: patient has NOT had >33 months therapy OR there is support for continued use (≥20% inhibitor decrease in 6 months).

Approval duration

One-time emergency: 2 weeks; Peri-operative: 1 time per request; On-demand: 3 months; Prophylaxis: 12 months; ITT/ITI: 6 months or up to total 33 months therapy (or requested duration, whichever is shortest)