Tedizolid Medicine 13 December 2018 Extended indication Hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), complex bacterial infections, caused by gram positive pathogens Therapeutic value Possible equal value Total cost € 496,650.00 Registration phase Clinical trials Product Active substance Tedizolid Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Bacterial infections Extended indication Hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), complex bacterial infections, caused by gram positive pathogens Current proprietary name Already available biosimilars / generics Proprietary name Sivextro Manufacturer MSD Portfolio holder Mechanism of action Antibiotic Route of administration Oral Therapeutical formulation Tablet Budgetting framework Unknown Centre of expertise Additional remarks Toedieningsvorm: tablet/injectievloeistof. Bekostigingskader: Geneesmiddelen vergoedingssysteem voor tabletten / Medisch Speciale Zorg voor intraveneus. Ribosomal protein inhibitors. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options linezolid Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Klinische studies laat zien dat tedizolid gelijkwaardig is aan linezolid voor behandeling ABSSSI. Tedizolid heeft mogelijk minder bijwerkingen. Duration of treatment Average 6 day / days Frequency of administration 1 times a day Dosage per administration 200 mg References NCT02019420, Farmacotherapeutisch Kompas Additional remarks Tedizolid is thought to have less frequent dosing, minimal interaction with serotonergic agents, and less adverse events associated with the impairment of mitochondrial protein synthesis that lead to myelosuppression, peripheral and optic neuropathy compared to linezolid. Expected patient volume per year Patient volume < 473 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks In 2017 waren er voor linezolid 473 gebruikers. Een deel van deze gebruikers kan worden overgezet op tedizolid gezien het hier alleen om de patiënten gaat voor bovenstaande indicatie. Kortom, beperkt aantal patiënten. Expected cost per patient per year Cost € 1,000.00 - 1,100.00 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 G-standaard; fabrikant Additional remarks Tedizolid tablet 200mg AIP per april 2019: €173,95 per tablet (exclusief BTW). Bij een behandelduur van 6 dagen komt dit neer op €1.043,70 Potential total cost per year Total cost € 496,650.00 Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Open Forum Infectious Diseases, Volume 3, Issue suppl_1, 1 December 2016, 577, Additional remarks Indication extension Indication extensions No Indication extensions References adisinsight.nl Additional remarks Other information Additional remarks