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 € 525,000.00 Registration phase Registered 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 Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie mei 2024. Geregistreerd op 26 juli 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 2 times a day Dosage per administration 5 mg References NCT02464969 (CANINES) Additional remarks The recommended dose of apixaban in paediatric patients weighing ≥ 35 kg is 10 mg twice daily (Day 1 - 7) and 5 mg twice daily (Day 8 and beyond). For paediatric patients weighing < 35 kg, new pharmaceutical forms; granules in capsules for opening, and coated granules in sachet will be administered. Refer to EPAR: Product Information under reference section for dose recommendations. 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 € 1,500.00 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 Medicijnkosten.nl Additional remarks Gemiddelde prijs per dag ELIQUIS, 10 mg € 4,49. Potential total cost per year Total cost € 525,000.00 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