EQWILATE (von Willebrand factor + human coagulation factor VIII)
Reason for request
High clinical benefit in von Willebrand’s disease, but no demonstrated clinical benefit in the therapeutic strategy.
Insufficient clinical benefit to justify reimbursement for haemophilia A.
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EQWILATE has been granted marketing authorisation in the prophylaxis and treatment of bleeding episodes in patients with congenital haemophilia A, in the prophylaxis and treatment of surgical bleeding or bleeding in patients over the age of 6 years with von Willebrand’s disease, and when desmopressin treatment alone is ineffective or contraindicated.
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In von Willebrand’s disease, the haemostatic efficacy of EQWILATE was no different from that of VONCENTO, WILSTART or WILFACTIN. The available data do not allow these medicinal products to be compared.
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In haemophilia A, the benefit of combining von Willebrand factor with factor III has not been demonstrated; consequently, EQWILATE has no role over purified factor VIII concentrates in this indication.
Clinical Benefit
Substantial |
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Insufficient |
Clinical Added Value
no clinical added value |
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Not applicable |
Therapeutic use
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