Scope: This policy defines prior authorization, coverage criteria, dosing limits, and prescribing requirements for Vonvendi (recombinant von Willebrand factor) for treatment of von Willebrand disease (VWD) under the medical benefit. Vonvendi is covered with criteria for on-demand treatment, perioperative management, and routine prophylaxis in severe Type 3 VWD when other criteria are met. The agent must be prescribed by or in consultation with a hematologist.
Coverage stance and criteria summary: Approval is recommended when the patient has a diagnosis of VWD and the agent is prescribed by or in consultation with a hematologist. For on-demand treatment and perioperative management, dosing is allowed up to a ceiling of 900 IU/kg intravenously no more frequently than once every 28 days. For routine prophylaxis in patients with severe Type 3 VWD previously treated on-demand, dosing is allowed up to 60 IU/kg intravenously no more frequently than twice weekly. Requests for doses outside these limits will be reviewed case-by-case by a clinician.
Authorization duration: Typical authorization is for 1 year when prescribed by or in consultation with a hematologist. The policy also allows for individualized dosing and provides for prophylactic therapy plus additional acute/perioperative coverage (prophylactic plus three days of acute/perioperative management per 28 days) consistent with dosing considerations.