Apixaban Medicine 04 June 2024 Extended indication Extension to the existing indication to include treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in children, associated with the addition of new pharmaceutical forms and new strengths (0.15mg granules in capsules for opening, as well as 0.5mg, 1.5mg and 2mg coated granules in sachet) Therapeutic value Possible benefit in ease of use Total cost Registration phase Registered and reimbursed Product Active substance Apixaban Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Antithrombotic medications Extended indication Extension to the existing indication to include treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in children, associated with the addition of new pharmaceutical forms and new strengths (0.15mg granules in capsules for opening, as well as 0.5mg, 1.5mg and 2mg coated granules in sachet) Current proprietary name Already available biosimilars / generics Proprietary name Eliquis Manufacturer BMS Portfolio holder Mechanism of action Anticoagulant Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date August 2023 Expected Registration July 2024 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie mei 2024 Therapeutic value Current treatment options Subcutaan laag moleculair heparine (LMWH) of oraal vitamine K antagonist Therapeutic value Possible benefit in ease of use This assessment does not indicate any potential inclusion in the package. Substantiation Er is mogelijk een voordeel in toedieningsgemak met de nieuwe toedieningsvormen. Er zijn nog geen studieresultaten om de therapeutische waarde verder te onderbouwen. Duration of treatment Frequency of administration Dosage per administration References NCT02464969 (CANINES) Additional remarks Expected patient volume per year Patient volume < 350 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Kindertrombose. Werkgroep Pediatrische Trombose en Stroke. 2024 (1). Additional remarks Veneuze trombo-embolie (VTE) omvat zowel diepe veneuze trombose (DVT) als longembolie. DVT en longembolie treden jaarlijks op bij ongeveer 350 kinderen in Nederland (1). 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks