Ceftazidime / avibactam

Active substance
Ceftazidime / avibactam
Domain
Infectious diseases
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Bacterial infections
Extended indication
Extension of indication to include bacteraemia (in association with, or 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.

1. Product

Proprietary name
Zavicefta
Manufacturer
Pfizer
Mechanism of action
Antibiotic
Route of administration
Intravenous
Therapeutical formulation
Intravenous drip
Budgetting framework
Intermural (MSZ)

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
December 2019
Expected Registration
August 2020
Orphan drug
No
Registration phase
Registration application pending
Additional comments
Volgens fabrikant verwachte registratie in Q3 2020.

3. 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.
Duration of treatment
Not found

4. 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.

5. Expected cost per patient per year

Cost
2,300
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.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.