Andexanet alfa Medicine 09 January 2018 Extended indication Voor het antagoneren van het effect van zogenaamde Xa-remmer (Anticoagulation reversal - antidote to oral factor Xa inhibitors - first-line) Therapeutic value Possible added value Total cost € 7,750,000.00 Registration phase Registration application pending Product Active substance Andexanet alfa Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Antithrombotic medications Extended indication Voor het antagoneren van het effect van zogenaamde Xa-remmer (Anticoagulation reversal - antidote to oral factor Xa inhibitors - first-line) Current proprietary name Already available biosimilars / generics Proprietary name Andexxa Manufacturer Portola Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Op dit moment is er geen enkel geneesmiddel beschikbaar dat de werking van zogenaamde Xa-remmers (direct oral anticoagulant) kan antagoneren in geval van bloedingen of acute bloedige interventies. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date September 2016 Expected Registration February 2019 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Er wordt gebruik gemaakt van protrombinecomplexconcentraat voor antagoneren effect Xa-remmers, maar daarvan is het therapeutisch effect niet bewezen. Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Op dit moment is er geen enkel geneesmiddel beschikbaar dat de werking van zogenaamde Xa-remmers (direct oral anticoagulant) kan antagoneren in geval van bloedingen of acute bloedige interventies. Duration of treatment Frequency of administration Dosage per administration References Connolly et al.; N Engl J Med. 2016 Sep 22;375(12):1131-41. doi: 10.1056/NEJMoa1607887 Additional remarks Voor incidentieel gebruik Expected patient volume per year Patient volume < 1,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Voor incidenteel gebruik komen maximaal 1.000 patiënten in aanmerking. Expected cost per patient per year Cost € 7,500.00 - 8,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References http://www.biopharminsight.com/portola-s-andexanet-alfa-factor-xa-inhibitor-reversal-likely-see-high-price-prompt-conservative Additional remarks Verwachting in de Verenigde Staten: $7.500- 8.000 per toediening. Potential total cost per year Total cost € 7,750,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks