Tebipenem Medicine 08 June 2021 Extended indication Complicated urinary tract infection (cUTI) or acute pyelonephritis (AP). Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Tebipenem Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Bacterial infections Extended indication Complicated urinary tract infection (cUTI) or acute pyelonephritis (AP). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Spero Therapeutics Portfolio holder Mechanism of action Antibiotic Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Cell wall inhibitor. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date March 2026 Expected Registration April 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indieningsdatum op basis van primary completion datum fase 3 studie. Therapeutic value Current treatment options Meropenem of ceftazidime/avibactam Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Op dit moment zijn er nog weinig resultaten uit de trials bekend. Het is echter een interessant geneesmiddel aangezien het een carbepenem betreft dat oraal gegeven gaat worden. De inzet van meropenem neemt toe in het ziekenhuis waardoor patiënten uitbehandeld raken. Duration of treatment Maximal 10 day / days Frequency of administration 3 times a day Dosage per administration 600 mg References NCT03788967 Additional remarks TBPM-PI-HBr 600mg driemaal daags oraal innemen gedurende 7 tot 10 dagen. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Nethmap 2017; Nivel; Inschatting Plazomicin; Additional remarks Afgelopen jaren is het meropenem gebruik verviervoudigd, medegedreven door ESBL infecties, met name urineweginfecties. Incidentie urineweginfecties is 40 tot 60 per 1.000 volwassen inwoners. In de Nederlandse huisartsenpraktijk bedraagt de incidentie van nierbekkenontsteking 30 tot 40 per 1.000 personen per jaar. Expected cost per patient per year Cost References Additional remarks 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 No Indication extensions References adisinsight Additional remarks Other information Additional remarks