Wilate — Blue Cross Blue Shield of New Mexico

Initial criteria

• The requested agent is eligible for continuation of therapy AND 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
• Diagnosis of hemophilia A AND ONE of the following: patient currently experiencing a bleed and is out of medication and needs a one-time emergency supply; OR requested agent is FDA labeled or compendia supported for hemophilia A AND being used for prophylaxis, immune tolerance therapy/induction (ITT/ITI), on-demand use for bleeds, or peri-operative management
• If used for prophylaxis or ITT/ITI, patient will NOT be using the requested agent in combination with Hemlibra (emicizumab-kxwh)
• For ITT/ITI use, ONE of the following: patient has NOT had more than 33 months of ITT/ITI therapy OR there is support for the continued use of ITT/ITI therapy (≥20% decrease in inhibitor level over the last 6 months and needs further treatment to eradicate inhibitors)
• Diagnosis of von Willebrand disease AND requested agent is FDA labeled or compendia supported for VWD AND ONE of the following: patient currently experiencing a bleed and out of medication needing a one-time emergency supply OR patient has type 1, 2A, 2M or 2N VWD AND has tried and had inadequate response, intolerance, contraindication or lack of availability of desmopressin OR patient has type 2B or 3 VWD
• For VWD use: requested agent will be used for prophylaxis, on-demand, or peri-operative management; if used for prophylaxis, and the agent is Vonvendi, it must be for severe type 3 VWD or another FDA labeled subtype
• If patient has an FDA labeled indication, patient’s age is within FDA labeling OR use is supported for patient’s age
• Prescriber must be a specialist in the area of diagnosis (e.g., hemophilia treatment center hematologist) or have consulted with one
• Patient does not have any FDA labeled contraindications to the requested agent
• Prescriber must provide prescribed dose, patient weight, intended use/regimen, severity of factor deficiency, and inhibitor status (for hemophilia A)
• The patient will NOT be using the requested agent in combination with another agent in the same category (Factor VIII or Factor VIII/von Willebrand Factor combination) OR there is support for using more than one agent
• Compendia allowed: AHFS or DrugDex level 1, 2a, or 2b

Reauthorization criteria

• Patient previously approved through the plan’s Prior Authorization process
• If used for prophylaxis, ONE of the following: patient has hemophilia A and will NOT use requested agent in combination with Hemlibra OR patient has another diagnosis
• Prescriber is a specialist in the area of the patient’s diagnosis or has consulted with one
• Patient does NOT have any FDA labeled contraindications
• Prescriber must provide prescribed dose, patient weight, intended use/regimen, and if hemophilia A, both severity of factor deficiency and inhibitor status
• Prescriber verified patient does not have greater than 5 on-demand doses on hand OR there is support for having more than 5 doses
• Patient will NOT use requested agent with another agent in same category OR use of multiple agents is supported
• If using ITT/ITI, patient will NOT be using requested agent with Hemlibra AND ONE of the following: patient has NOT had more than 33 months of ITT/ITI therapy OR there is support for continued ITT/ITI therapy (≥20% decrease in inhibitor level over 6 months and needs further treatment)

Approval duration

emergency 3mo; peri-op 3mo; on-demand 3mo; prophylaxis up to 12mo; ITT/ITI up to 6mo (≤33mo total)