Fibrinogen Medicine 10 December 2019 Extended indication Human fibrinogen concentrate monotherapy for treatment of Acquired fibrinogen deficiency in adults and elderly undergoing elective spinal or abdominal surgery with expected major blood loss. Therapeutic value Possible equal value Total cost Registration phase Clinical trials Product Active substance Fibrinogen Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Hemostasis promoting medication Extended indication Human fibrinogen concentrate monotherapy for treatment of Acquired fibrinogen deficiency in adults and elderly undergoing elective spinal or abdominal surgery with expected major blood loss. Current proprietary name Already available biosimilars / generics Proprietary name Evarrest Manufacturer Grifols Portfolio holder Grifols Mechanism of action Coagulant Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Stollingsfactor I, gepurificeerd uit humaan plasma. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP Submission date June 2026 Expected Registration July 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Bij Congenital Fibrinogen Deficiency is de behandeling met fibrinogeenconcentraat de eerste keuze (conform richtlijn hemofilie en aanverwante stollingsstoornissen). Er is op dit moment één alternatief voor fibrinogeenconcentraat genaamd Haemocomplettan op de markt. Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Naar verwachting zal fibrinogen voor deze indicatie beperkt in gebruik genomen worden. Duration of treatment Frequency of administration Dosage per administration References NCT02065882; fase 3 AdFIrst trial (NCT03444324) Additional remarks Wordt met name gebruikt bij behandelingen van korte duur. Expected patient volume per year Patient volume 17 - 153 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Orphanet Additional remarks De incidentie wordt geschat tussen de een en negen per 1.000.000 inwoners. Voor Nederland betekent dit tussen de 17 en 153 patiënten. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Acquired fibrinogen deficiency References Website Biotest Additional remarks Zal met name gebruikt worden voor tekorten die optreden na groot trauma, bloedverlies na bevallingen et cetera. Other information Additional remarks