Ceftolozane / tazobactam Medicine 07 December 2021 Extended indication Extension of indication to include treatment of paediatric patients aged birth to less than 18 years for Zerbaxa. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Ceftolozane / tazobactam Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Bacterial infections Extended indication Extension of indication to include treatment of paediatric patients aged birth to less than 18 years for Zerbaxa. Current proprietary name Already available biosimilars / generics Proprietary name Zerbaxa Manufacturer Merck Portfolio holder Mechanism of action Antibiotic Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Beta lactamase inhibitors; Cell wall inhibitor. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date June 2021 Expected Registration April 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume 30 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Het is een geneesmiddel met een relatief smal antimicrobieel spectrum , wat pas bij het Nederlandse beleid om carbapenem-sparend voor te schrijven. Op dit moment wordt voornamelijk meropenem voorgeschreven wat mogelijk ook goedkoper zal zijn dan Zerbaxa. De meeste laboratoria zullen ook niet in de standaard testen en dat werkt ook beperkend. Rekening houdend met deze factoren wordt het gebruik ingeschat op 30 patiënten 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 Unknown Indication extensions References Additional remarks Other information Additional remarks