Canakinumab Medicine 09 January 2018 Extended indication Afname cardiovasculair risico Therapeutic value No judgement Total cost € 3,000,000,000.00 Registration phase Unknown Product Active substance Canakinumab Domain Cardiovascular diseases Reason of inclusion Main indication Cardiovascular diseases Extended indication Afname cardiovasculair risico 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 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date October 2017 Expected Registration January 2019 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options PCSK9 remmers Therapeutic value No judgement 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. AHJ October 2011, Volume 162, Issue 4, Pages 597–605. Additional remarks Expected patient volume per year Patient volume < 60,000 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 patienten in Nederland die een myocard infarct hebben doogemaakt, waarvan 25% een verhoogde biomarker hsCRP heeft (vereiste voor behandeling). De werkgroep geeft aan dat het percentage van 25% met een verhoogde biomarker hsCRP hoger ligt. 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 Meerkosten. €11.660,00 per injectieflacon. Potential total cost per year Total cost € 3,000,000,000.00 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