Version 2

Ceftazidime / avibactam

Medicine

Extended indication Extension of indication to include treatment of paediatric patients from birth to less than 3-months of age in the following infections: complicated i
Therapeutic value Possible equal value
Registration phase Registered and reimbursed

Product

Active substance Ceftazidime / avibactam
Domain Infectious diseases
Reason of inclusion Indication extension IND
Main indication Bacterial infections
Extended indication Extension of indication to include treatment of paediatric patients from birth to less than 3-months of age in the following infections: complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI), including pyelonephritis, hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) and in the treatment of infections due to aerobic Gram-negative organisms in patients with limited treatment options.
Proprietary name Zavicefta
Manufacturer Pfizer
Mechanism of action Antibiotic
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Unknown
ATMP No
Submission date February 2024
Expected Registration October 2024
Orphan drug No
Registration phase Registered and reimbursed

Therapeutic value

Current treatment options Meropenem
Therapeutic value Possible equal value

This assessment does not indicate any potential inclusion in the package.
Substantiation Naar verwachting zal in met name de huidige behandeloptie meropenem gebruikt worden voor deze indicatie. Ceftazidime/avibactam kan wel gekozen gaan worden als besparend regime. Het geneesmiddel heeft een breed werkingsspectrum. Het aantal kinderen met een gecompliceerde urineweginfectie waarbij antibiotica met een smaller spectrum niet meer gegeven kan worden door resistentie is zeer beperkt. Het geneesmiddel kan veilig en effectief ingezet worden binnen deze patiëntpopulatie (1).
Duration of treatment Maximal 14 day / days
Frequency of administration 3 times a day
References Horizonscan Geneesmiddelen Zavicefta. 2021. (1); NCT04126031 (NOOR) (2).
Additional remarks De infusie wordt over 2 uur gegeven, meestal 3 keer per dag. De behandelduur is meestal tussen de 5 en 14 dagen.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.
Additional remarks De uitbreiding van de huidige indicatie naar baby's van 0 tot 3 maanden zal weinig invloed hebben op de patiëntaantallen.

Expected cost per patient per year

Cost € < 6,831.00

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 GIPdatabank (1)
Additional remarks De vergoeding per gebruiker in 2021 van Zavicefta was €6.831,70 (1).

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information