Wilate — Blue Cross Blue Shield of Illinois
von Willebrand disease (VWD) type 2A
Initial criteria
- ONE of the following: A. The patient is eligible for continuation of therapy AND has been treated with the requested agent within the past 90 days and is at risk if therapy is changed OR B. The following condition-specific criteria apply.
- For hemophilia A: the patient has a diagnosis of hemophilia A AND ONE of the following: 1. The patient is currently experiencing a bleed AND BOTH (the patient is out of medication AND needs a one-time emergency supply) OR 2. ALL of the following: A. The requested agent is FDA labeled or compendia supported for hemophilia A AND B. The requested agent is being used for ONE of the following: (1) Prophylaxis AND will NOT be used with Hemlibra (emicizumab-kxwh) OR (2) As a component of Immune Tolerance Therapy/Induction (ITT/ITI) AND BOTH (will NOT be used with Hemlibra) AND ONE of the following (medical records required): (a) patient has NOT had more than 33 months of ITT/ITI therapy OR (b) there is support for continued use (≥20% decrease in inhibitor level over last 6 months) OR (3) On-demand use for bleeds OR (4) Peri-operative management of bleeding.
- For von Willebrand disease: the patient has a diagnosis of VWD AND ALL of the following: (1) requested agent is FDA labeled or compendia supported for VWD AND (2) ONE of the following: A. the patient is currently experiencing a bleed AND BOTH (out of medication AND needs one-time emergency supply) OR B. the patient has type 1, 2A, 2M or 2N VWD AND ONE of the following: tried and had inadequate response to desmopressin (e.g., DDAVP injection, Stimate nasal spray), no response to DDAVP trial, intolerance/hypersensitivity, contraindication, or market shortage OR C. the patient has type 2B or 3 VWD AND (3) the requested agent will be used for ONE of the following: A. Prophylaxis AND ONE of the following: (1) agent is Vonvendi AND the patient has severe type 3 VWD OR another FDA labeled subtype OR (2) requested agent is NOT Vonvendi OR B. On-demand use for bleeds OR C. Peri-operative management of bleeding.
- If the patient has an FDA labeled indication, then ONE of the following: A. Age is within FDA labeling OR B. There is support for use for that age.
- Prescriber is a specialist in the area of the patient’s diagnosis (e.g., hemophilia treatment center hematologist) or has consulted such a specialist.
- Patient has no FDA labeled contraindications to the requested agent.
- Prescriber must provide actual prescribed dose with patient’s weight AND intended regimen (prophylaxis, ITT/ITI, on-demand, peri-operative) AND if hemophilia A, both severity (severe <1%, moderate 1–5%, mild 5–40%) AND inhibitor status.
- ONE of the following: A. The patient will NOT use another agent in the same category OR B. Medical record support for more than one agent.
- Compendia allowed: AHFS or DrugDex 1, 2a, 2b.
Reauthorization criteria
- Patient previously approved for requested agent through plan’s prior authorization process (emergency-use-only prior approvals require initial review).
- If prophylaxis: A. Patient has hemophilia A AND will NOT use in combination with Hemlibra OR B. Patient has another diagnosis.
- Prescriber is a specialist (or has consulted with one).
- Patient does NOT have any FDA labeled contraindications.
- Prescriber must provide actual prescribed dose with patient weight AND intended use/regimen AND if hemophilia A, both severity and inhibitor status.
- ONE of the following: A. Prescriber communicated with patient regarding bleed frequency/severity and verified no more than 5 on-demand doses on hand OR B. Medical record support for having more.
- ONE of the following: A. Patient will NOT use with another agent in same category OR B. Medical record support for >1 agent.
- If Immune Tolerance Therapy (ITT/ITI): BOTH (A) will NOT use with Hemlibra AND (B) ONE of the following (medical records required): patient has NOT had more than 33 months of ITT therapy OR support for continued use (≥20% decrease in inhibitor level over last 6 months).
Approval duration
For BCBSIL/BCBSTX: 12 months; BCBSMT/BCBSNM: emergency use 3 months, peri-operative 3 months, on-demand 3 months, prophylaxis up to 12 months (≥3 months), ITT up to 6 months or up to 33 months total (≥3 months); others: emergency 2 weeks, peri-operative 1-time, on-demand 3 months, prophylaxis 12 months, ITT 6 months or up to 33 months total.