Canakinumab Medicine 09 January 2018 Extended indication Secundaire preventie van cardiovasculaire incidenten bij patiënten met een doorgemaakt myocard infarct en inflammatoire atherosclerose. Therapeutic value Possible added value Total cost Registration phase Registration application pending Product Active substance Canakinumab Domain Cardiovascular diseases Reason of inclusion Main indication Other medication for cardiovascular diseases Extended indication Secundaire preventie van cardiovasculaire incidenten bij patiënten met een doorgemaakt myocard infarct en inflammatoire atherosclerose. Current proprietary name Already available biosimilars / generics Proprietary name Ilaris Manufacturer Novartis Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Canakinumab is a recombinant, human anti-human-IL-1β monoclonal antibody. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Indication extension ATMP Unknown Submission date February 2018 Expected Registration April 2019 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options PCSK9 remmers Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 4 times a year Dosage per administration References Ridker et al. NEJM 2017. Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; www.volksgezondheidenzorg.info; Ridker. JACC 2016, vol 67, no 6, 2016, 712-23. Additional remarks Fabrikant heeft max. patiëntvolume gebaseerd op circa 252.000 patiënten in Nederland die een myocard infarct hebben doogemaakt, waarvan 25% (63.000) een verhoogde biomarker hsCRP heeft (vereiste voor behandeling). Expected cost per patient per year Cost € 50,000.00 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 Zeer hoge meerkosten verwacht. €11.660,00 per injectieflacon. 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