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
Main indication Bacterial infections
Extended indication Hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP)
Proprietary name Zerbaxa
Manufacturer MSD
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Beta lactamase inhibitors; Cell wall inhibitors

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Therapeutic value No judgement
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.

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
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

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.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.