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Wilate — Blue Cross Blue Shield of Texas

von Willebrand disease (VWD)

Initial criteria

  • Agent is eligible for continuation of therapy AND patient has been treated with the requested agent within the past 90 days and at risk if therapy is changed OR new start meeting the following:
  • ONE of the following: diagnosis of Hemophilia A OR von Willebrand disease
  • For Hemophilia A: requested agent is FDA labeled or compendia supported for Hemophilia A AND agent used for ONE of: prophylaxis (not combined with Hemlibra), Immune Tolerance Therapy/Induction (ITT/ITI) (not combined with Hemlibra and EITHER not >33 months ITT/ITI OR ≥20% decrease in inhibitor level and needs further therapy), on-demand for bleeds, or peri-operative management of bleeding
  • For von Willebrand disease: requested agent is FDA labeled or compendia supported for VWD AND ONE of the following: (a) currently experiencing a bleed and needs one-time emergency supply, OR (b) type 1/2A/2M/2N disease with inadequate response, no response, intolerance or contraindication to desmopressin, or shortage, OR (c) type 2B or 3 disease
  • Requested agent will be used for ONE of: prophylaxis, on-demand, or peri-operative management
  • If prophylaxis: if Vonvendi is requested, must have severe type 3 VWD OR another subtype FDA labeled for prophylaxis; if not Vonvendi, other use allowed
  • Patient’s age is within FDA labeling or supported for requested indication
  • Prescriber is hematologist or hemophilia specialist (or has consulted such specialist)
  • Patient has no FDA labeled contraindications
  • Prescriber provides patient weight, intended regimen (prophylaxis, ITT/ITI, on-demand, peri-operative), and for Hemophilia A, severity (severe <1%, moderate 1–5%, mild 5–40%) and inhibitor status
  • Patient will not use another agent in same category unless supported (medical records required)

Reauthorization criteria

  • Patient previously approved for requested agent (unless emergency use only)
  • If prophylaxis: patient has Hemophilia A and not using in combination with Hemlibra OR has another diagnosis
  • Prescriber is hematologist/hemophilia specialist or has consulted one
  • Patient has no FDA labeled contraindications
  • Prescriber provides dose, weight, and intended regimen details; for Hemophilia A specify severity and inhibitor status
  • Prescriber confirms communication with patient and verifies not >5 on‑demand doses on hand OR provides support for greater number
  • Patient will not use another agent in same category unless supported by records
  • If using ITT/ITI: not combined with Hemlibra AND EITHER not >33 months ITT/ITI OR ≥20% inhibitor decrease in last 6 months and needs further therapy

Approval duration

initial: 12 months (BCBSIL/BCBSTX); reauth: 12 months; emergency/peri‑operative/on‑demand shorter durations as defined (3 months typical); ITT/ITI up to 6 months or total 33 months therapy