Cefepime / enmetazobactam Medicine 07 December 2022 Extended indication Treatment of the following infections in adults: - Complicated urinary tract infections (cUTI), including pyelonephritis - Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Cefepime / enmetazobactam Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Infectious diseases other Extended indication Treatment of the following infections in adults: - Complicated urinary tract infections (cUTI), including pyelonephritis - Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Current proprietary name Already available biosimilars / generics Proprietary name Exblifep Manufacturer Allecra Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks β-lactam antibioticum/β-lactamaseremmer Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date January 2023 Expected Registration March 2024 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Geregistreerd maart 2024 Therapeutic value Current treatment options Meropenem. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Dit geneesmiddel zou in plaats van meropenem ingezet kunnen gaan worden. Cefepime/enmetazobactam is een antibioticum dat werkzaam is tegen ESBL en AMPc . Hiermee is het een carbapenem-sparend antibioticum. De verwachting is dat het in de praktijk nauwelijks ingezet zal worden. Door de intraveneuze toediening en het bijwerkingenprofiel zullen artsen waarschijnlijk eerder voor meropenem of een ander carbapenem-sparend antibioticum kiezen. Duration of treatment Minimal 7 day / days Frequency of administration 3 times a day Dosage per administration Cefepime 2 g/enmetazobactam 0,5 g References ALLIUM Trial (NCT03687255) Additional remarks Cefepime 2 gram/enmetazobactam 0,5 gram every eight hours as a two-hour continuous intravenous infusion. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Nethmap 2017(1); Nivel (2); Expert opinie (3); Additional remarks Afgelopen jaren is het meropenem gebruik verviervoudigd, mede gedreven door ESBL infecties, met name urineweginfecties. Incidentie urineweginfecties is 40 tot 60 per 1.000 volwassen inwoners (1). In de Nederlandse huisartsenpraktijk bedraagt de incidentie van nierbekkenontsteking 30 tot 40 per 1.000 personen per jaar (2). Er wordt verwacht dat dit geneesmiddel nauwelijks zal worden ingezet in de praktijk (3). Expected cost per patient per year Cost € 1,953.00 - 2,231.00 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; FK Additional remarks De prijs van andere recent goedgekeurde β-lactamcombinaties (Zerbaxa, Zavicefta) kosten tussen de € 101,41 en € 115,84 per injectieflacon. Een behandelkuur van 7 dagen ligt met deze prijzen tussen de €1.953,77 en €2.231,78 kosten (excl. BTW). 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 Unknown Indication extensions References Additional remarks Other information Additional remarks