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Durvalumab

Imfinzi

Extended indication Blaaskanker
Therapeutic value No judgement
Total cost 14,350,000.00
Registration phase Clinical trials

Product

Active substance Durvalumab
Domain Oncology and Hematology
Main indication Bladder cancer
Extended indication Blaaskanker
Proprietary name Imfinzi
Manufacturer AstraZeneca
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks PD-L1 remmer

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Platinum doublet chemotherapie
Therapeutic value No judgement
Frequency of administration 1 times every 4 weeks
Dosage per administration 1500 mg
References NCT02516241
Additional remarks Toedingsfrequentie 1 maal per 4 weken

Expected patient volume per year

Patient volume

150 - 200

Market share is generally not included unless otherwise stated.
Additional remarks De fabrikant geeft aan dat het realistische en maximale patiëntenvolume respectievelijk 515 en 686 bedraagd. De werkgroep verwacht vergelijkbare patiëntvolumes zoals bij Pembrolizumab met de zelfde indicatie, te weten 150 en 200 patiënten.

Expected cost per patient per year

Cost 82,000.00
References Fabrikant; Pakketadvies pembrolizumab (Keytruda®) 2016 Zorginstituut Nederland Diemen
Additional remarks Naar verwachting is de maandelijkse kostprijs vergelijkbaar met maandelijkse kostprijs van pembrolizumab (€6.810).

Potential total cost per year

Total cost

14,350,000.00

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.

Off label use

Off label use No

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.