Cadazolid Medicine 09 January 2018 Extended indication Behandeling van Clostridium difficile infectie (diarree). Therapeutic value Possible equal value Total cost € 4,200,000.00 Registration phase Withdrawn Product Active substance Cadazolid Domain Infectious diseases Reason of inclusion Main indication Bacterial infections Extended indication Behandeling van Clostridium difficile infectie (diarree). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Actelion Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Granulate Budgetting framework Extramural (GVS) Centre of expertise LUMC Additional remarks Nieuw geneesmiddel, een hybride van een fluorochinolon en een oxazolidinone antibioticum klasse. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New medicine ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase Withdrawn Reimbursement Medicine sluice Additional remarks Klinische studies stopgezet in april 2018 wegens tegenvallende resultaten (FierceBiotech). Therapeutic value Current treatment options Substituut voor onder andere metronidazol, glycopeptide, fidaxomicine, etc. Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 10 day / days Frequency of administration 2 times a day Dosage per administration 250 mg References Pubmed; Google Scholar; ECCMID richtlijn. Clin Microbiol Infect 2016; 22 (Suppl. 4); Ooijevaar et al, Update of treatment algorithms for Clostridium difficile infection; Louie et al. Antimicrob Agents Chemother 59(10) (2015) 6266-73. Additional remarks Expected patient volume per year Patient volume < 2,800 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References RIVM Additional remarks Geschat wordt dat ongeveer 2800 opgenomen patiënten CDI ontwikkelen. Expected cost per patient per year Cost € 1,000.00 - 2,000.00 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 Prescribing outlook 2017. Medicijnkosten.nl. Additional remarks Prescribing outlook 2017: 'Assuming it is similarly priced to fidaxomicin (£1,350 for a 10-day course) there are unlikely to be significant additional cost implications.' Medicijnkosten.nl: Fidaxomicin is 82,08 voor 200 mg uitgaande van 10 dagen behandeling, 2x per dag: 1.642. Potential total cost per year Total cost € 4,200,000.00 Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks