Extended indication Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associ
Therapeutic value No estimate possible yet
Registration phase Registered and reimbursed

Product

Active substance Ceftazidime / avibactam
Domain Infectious diseases
Reason of inclusion Indication extension
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
Submission date November 2019
Expected Registration August 2020
Orphan drug No
Registration phase Registered and reimbursed
Additional comments Positieve CHMP-opinie juni 2020. Zavicefta heeft een add-on status.

Therapeutic value

Therapeutic value No estimate possible yet
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

References Expertopinie
Additional comments 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
References G-standaard
Additional comments 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

There is currently nothing known about the possible total cost.

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.