Extended indication Voor het antagoneren van het effect van zogenaamde Xa-remmer (Anticoagulation reversal - antidote t
Therapeutic value Possible added value
Total cost 7,750,000.00
Registration phase Registration application pending

Product

Active substance Andexanet alfa
Domain Cardiovascular diseases
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)
Proprietary name Andexxa
Manufacturer Portola
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
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 New medicine
Submission date September 2016
Expected Registration August 2018
Orphan drug No
Registration phase Registration application pending

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
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.
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.

Additional remarks Voor incidenteel gebruik komen maximaal 1.000 patiƫnten in aanmerking.

Expected cost per patient per year

Cost 7,500.00 - 8,000.00
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: 7500 - 8000 USD per toediening.

Potential total cost per year

Total cost

7,750,000.00

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.

Off label use

Off label use No

Indication extension

Indication extension No

Other information

There is currently no futher information available.