Version 2

Ceftazidime / avibactam

Medicine

Extended indication Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, the currently approved indications for
Therapeutic value No judgement
Registration phase Registered

Product

Active substance Ceftazidime / avibactam
Domain Infectious diseases
Reason of inclusion Indication extension IND
Main indication Bacterial infections
Extended indication Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, the currently approved indications for complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI) and hospital-acquired pneumonia, including ventilator-associated pneumonia.
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 Unknown
Submission date November 2019
Expected Registration August 2020
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP-opinie juni 2020.

Therapeutic value

Therapeutic value No judgement

This assessment does not indicate any potential inclusion in the package.
Substantiation De toevoeging van bacteriemie aan de bestaande indicatie zal weinig invloed hebben op de therapeutische meerwaarde. Het complexe, moeilijkste behandelbare gedeelte van de infectie is de gecompliceerde buikinfectie.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.
References Expertopinie
Additional remarks De toevoeging van bacteriemie aan de bestaande indicatie zal weinig invloed hebben op de patiëntenaantallen. Het aantal gebruikers zal daarom beperkt zijn.

Expected cost per patient per year

Cost € 2,300.00

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 G-standaard
Additional remarks Voor een volwassen patiënt die driemaal per dag wordt behandeld voor 7 dagen, zijn de kosten €2.232 per behandelcyclus.

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information