Extended indication

Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associ

Therapeutic value

No judgement

Registration phase

Registered

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

Additional comments
Positieve CHMP-opinie juni 2020.

Therapeutic value

Therapeutic value

No judgement

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.