Apixaban oraal oplosbare film Medicine 04 June 2026 Extended indication Apixaban monotherapy to demonstrate bioequivalence to the reference product Eliquis®. Therapeutic value Possible benefit in ease of use Total cost € 412,500.00 Registration phase Clinical trials Product Active substance Apixaban oraal oplosbare film Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Antithrombotic medications Extended indication Apixaban monotherapy to demonstrate bioequivalence to the reference product Eliquis®. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer TAHO Portfolio holder TAHO Mechanism of action Route of administration Oral Therapeutical formulation Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP Submission date May 2026 Expected Registration June 2027 Orphan drug Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Possible benefit in ease of use This assessment does not indicate any potential inclusion in the package. Substantiation De fabrikant geeft aan dat deze nieuwe toedieningsvorm een uitkomst biedt bij mensen met slikproblemen. Mogelijk biedt deze nieuwe toedieningsvorm die oraal geresorbeerd wordt een meerwaarde bij een extreem kleine populatie van patiënten, bijvoorbeeld patiënten met short bowel syndrome. Duration of treatment Frequency of administration Dosage per administration References NCT06689436 Additional remarks Expected patient volume per year Patient volume 500 - 1,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Declaratiedata; Expertopinie Additional remarks In 2024 waren er bijna 260.000 gebruikers van tabletten apixaban. Mogelijk komen er tussen de 500 tot maximaal 1.000 patiënten in aanmerking voor deze nieuwe toedieningsvorm. Expected cost per patient per year Cost € 500.00 - 600.00 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 Declaratiedata Additional remarks In 2024 was de gemiddelde vergoeding per gebruiker apixaban €592,50. Mogelijk zal deze nieuwe toedieningsvorm duurder zijn. Potential total cost per year Total cost € 412,500.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks