Von Willebrand disease: cross-border specialty drug access for international patients

Quick orientation

Von Willebrand disease affects an estimated 1 in 100 to 1 in 10,000 people depending on the threshold for diagnosis. Severe forms are far less common.

Typical age of onset. Congenital; symptomatic presentation can occur at any age, often with surgery, dental procedures, or menstruation.

Severity tiers. Severity is graded by VWF levels, multimer pattern, and bleeding history.

Why specialty drugs for Von Willebrand disease are hard to access internationally

Vonvendi (recombinant von Willebrand factor) is the only FDA-approved recombinant product for VWD. Plasma-derived VWF/FVIII concentrates are widely used. International registration of the recombinant product is in select markets.

Treatments approved by the FDA

• Vonvendi (vonicog alfa) — FDA approval: 2015. Mechanism: Recombinant von Willebrand factor. Route: Intravenous infusion on-demand or prophylactic. US WAC ballpark: Approximately USD 1.50 to 2.50 per IU; total cost varies. Country pricing: UAE · Saudi Arabia · India · Bahrain.
• Qfitlia (fitusiran) — FDA approval: 2025. Mechanism: Antithrombin RNAi (hemophilia label; adjacent hemostasis biology). Route: Subcutaneous injection monthly. US WAC ballpark: Approximately USD 500,000 per year. Country pricing: India · Kuwait · Oman · Lebanon.

Cross-border pathways used for Von Willebrand disease

Most patients use one or more of the following regulatory pathways, depending on the destination country and the specific drug:

• Named Patient Program (NPP)
• Expanded Access Program (EAP)
• Compassionate Use
• Personal Import Scheme

What your physician needs to know

• Confirm VWD type and subtype.
• Document VWF activity, antigen, multimers, and bleeding history.
• Hematology specialist with bleeding disorder experience co-manages.
• Cold-chain or controlled-temperature shipping is required.
• Plan supply for surgical and dental procedures.

Common questions

Is Vonvendi available in my country?

Registration is in select markets. We confirm by destination.

Should my child receive prophylaxis?

Prophylactic therapy is considered for severe disease or recurrent bleeding. Your hematologist decides.

How is the infusion administered?

At a hospital, outpatient clinic, or qualified home infusion service per local regulations.

How long does shipment take?

Five to fifteen business days from prescription receipt.

What documents are required?

Hematologist's prescription, VWD subtype, bleeding history, and clinical summary.

Where Reserve Meds fits in

Reserve Meds is a cross-border specialty drug access platform. We support international patients whose prescribed FDA-approved medicine is not registered locally, is not reimbursed by their payer, or is otherwise unavailable through standard channels. For Von Willebrand disease, our role is to coordinate the regulatory pathway, source the medicine from a DSCSA-compliant US wholesaler, and arrange validated cold-chain or controlled-temperature shipment to the destination country.

We do not replace your treating physician. We do not bill insurance. We operate a cash-pay model, and we work alongside the clinical team that knows your case. Every prescription is reviewed by a US-licensed pharmacist before dispense, and a US-licensed physician reviews the supply request before shipment.

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