Ceftolozaan / tazobactam Medicine 13 December 2018 Extended indication Hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) Therapeutic value No judgement Total cost € 483,750.00 Registration phase Clinical trials Product Active substance Ceftolozaan / tazobactam Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Bacterial infections Extended indication Hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) Current proprietary name Already available biosimilars / generics Proprietary name Zerbaxa Manufacturer MSD Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Beta lactamase inhibitors; Cell wall inhibitors Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 14 day / days Frequency of administration 3 times a day Dosage per administration 2.000 mg / 1.000 mg References ASPECT-NP NCT02070757 Additional remarks Ceftolozane/tazobactam IV 3.000 mg (comprising 2.000 mg ceftolozane and 1.000 mg tazobactam) every 8 hours for 8-14 days, or 14 days for Pseudomonas aeruginosa. Expected patient volume per year Patient volume 50 - 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks zeer beperkt aantal patiënten, inschatting experts 50 - 100 patiënten per jaar. Expected cost per patient per year Cost € 4,700.00 - 8,200.00 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; NCT02070757 Additional remarks 1 injectieflacon poeder voor oplossing voor infusie 1.000/500mg FL € 97,17. Volgens het behandelschema krijgt een patiënt 6 flacons per dag toegediend (€583,02) en duurt de kuur 8-14 dagen (€4.664,16 - €8.162,28). Zerbaxa poeder voor concentraat voor oplossing voor infusie wordt bij gebruik in het ziekenhuis betaald uit het ziekenhuisbudget. Het is niet vergoed buiten het ziekenhuis. Potential total cost per year Total cost € 483,750.00 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