Apixaban Medicine 10 December 2019 Extended indication Pevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Therapeutic value Possible equal value Total cost Registration phase Registered Product Active substance Apixaban Domain Cardiovascular diseases Reason of inclusion Generic G Main indication Antithrombotic medications Extended indication Pevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Current proprietary name Eliquis (BMS) Already available biosimilars / generics Proprietary name Apixaban Accord Manufacturer Accord Healthcare Portfolio holder Mechanism of action Anticoagulant Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Unknown Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date July 2019 Expected Registration July 2020 Orphan drug Unknown Registration phase Registered Reimbursement Medicine sluice Additional remarks SPC Eliquis verloopt op 19 mei 2026. Voor Eliquis loopt een financieel arrangement dat afloopt per december 2023. Positieve CHMP-opinie mei 2020. Therapeutic value Current treatment options Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks 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