Tedizolid Medicine 03 December 2024 Extended indication Extension of the indication for the treatment of acute bacterial skin and skin structure infections (ABSSSI) for adults, adolescents and children weighing at least 35 kg. Therapeutic value No estimate possible yet Total cost € 47,250.00 Registration phase Registered Product Active substance Tedizolid Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Bacterial infections Extended indication Extension of the indication for the treatment of acute bacterial skin and skin structure infections (ABSSSI) for adults, adolescents and children weighing at least 35 kg. 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 Extramural (GVS) Centre of expertise Additional remarks Toedieningsvorm: tablet/injectievloeistof. Bekostigingskader: GVS voor tabletten / MSZ voor intraveneus Ribosomal protein inhibitors. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date July 2024 Expected Registration February 2025 Orphan drug No Registration phase Registered Reimbursement Reimbursed from the basic package Medicine sluice Additional remarks Positieve CHMP opinie januari 2025 Therapeutic value Current treatment options Antiobiotica (e.g., linezolid) Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Tedizolid kan als tablet of injectievloeistof toegediend worden. Er wordt niet veel therapeutische meerwaarde ten opzichte van linezolid verwacht. Een voordeel voor een klein aantal patiënten zal zijn dat er minder beenmerg toxiciteit plaatsvindt. Dit zal een uitkomst bieden voor patiënten die gevoelig zijn voor orthopedische infecties. Duration of treatment Average 6 day / days Frequency of administration 1 times a day Dosage per administration 200mg References NCT03176134 (MK-1986-018) Additional remarks Expected patient volume per year Patient volume 40 - 50 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie (1). Additional remarks De inschatting is dat er 40 tot 50 kinderen in aanmerkingen zullen komen voor dit middel (1). 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 apothekers inkoopprijs 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 € 47,250.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Nosocomial pneumonia; Ventilator associated pneumonia References Adisinsight. 2024. Additional remarks Other information Additional remarks