Nacubactam Medicine 03 June 2025 Extended indication Nacubactam in combination with cefepime or aztreonam in patients with complicated urinary tract infections or acute uncomplicated pyelonephritis. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Nacubactam Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Bacterial infections Extended indication Nacubactam in combination with cefepime or aztreonam in patients with complicated urinary tract infections or acute uncomplicated pyelonephritis. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Meiji Seika Portfolio holder Mechanism of action Antibiotic Route of administration Intravenous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Meiji Seika Pharma Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date June 2026 Expected Registration July 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De verwachting is dat de inzet beperkt zal zijn. Duration of treatment Frequency of administration Dosage per administration References NCT05887908 (INTEGRAL-1) Additional remarks Expected patient volume per year Patient volume 50 - 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Nethmap 2017(1); Nivel (2); Expertopinie (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). Het aantal zal beperkt zijn. De afgelopen jaren wordt voornamelijk bij mensen uit Oekraïne die in Nederland behandeld worden meropenem resistente stammen aangetroffen. Een globale schatting is 50 tot 100 patiënten per jaar (3). 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks