Alirocumab Medicine 12 June 2018 Extended indication Extension of Indication to include the prevention of cardiovascular events in patients with established atherosclerotic cardiovascular disease. Therapeutic value Possible added value Total cost € 90,630,000.00 Registration phase Registration application pending Product Active substance Alirocumab Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Lipid-lowering medications Extended indication Extension of Indication to include the prevention of cardiovascular events in patients with established atherosclerotic cardiovascular disease. Current proprietary name Already available biosimilars / generics Proprietary name Praluent Manufacturer Sanofi Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks PCSK9 remmer Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date June 2018 Expected Registration April 2019 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options statins en/of ezetimibe Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab https://clinicaltrials.gov/ct2/show/NCT01663402 gepresenteerd op ACC 2018 Duration of treatment Frequency of administration 1 times every 2 weeks Dosage per administration 75 mg of 150 mg subcutaan References Additional remarks Expected patient volume per year Patient volume 8,800 - 23,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Uitbreiding vergoeding voor patiënten met 1 cardiovasculair event en niet behalen streefwaarde ondanks maximaal verdraagbare dosering van huidige medicatie (statine en/of ezetimibe) de LDL-streefwaarde niet bereikt wordt. Is binnen huidige geregistreerde indicatie. Additional remarks Expected cost per patient per year Cost € < 5,700.00 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; fabrikant Additional remarks Potential total cost per year Total cost € 90,630,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions References Additional remarks Other information Additional remarks