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Durvalumab / Tremelimumab

Imfinzi / Tremelimumab

Extended indication First line bladder cancer.
Therapeutic value No judgement
Total cost 26,400,000.00
Registration phase Clinical trials

Product

Active substance Durvalumab / Tremelimumab
Domain Oncology and Hematology
Main indication Bladder cancer
Extended indication First line bladder cancer.
Proprietary name Imfinzi / Tremelimumab
Manufacturer AstraZeneca
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Anti PD-L1 + anti CTLA-4.

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Submission date 2018
Expected Registration 2019
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Nivolumab
Therapeutic value No judgement
Frequency of administration 1 times every 4 weeks
Dosage per administration 1500 mg / 75 mg
References Fabrikant; NCT02516241
Additional remarks Toedingsfrequentie: Durvalumab 1 maal per 4 weken; Tremelimumab 1 maal per 4 weken met een maximum van 4 doses.

Expected patient volume per year

Patient volume

412 - 644

Market share is generally not included unless otherwise stated.
References Fabrikant; NKR
Additional remarks NKR 2016: 644 diagnoses blaaskanker stadium 4. Fabrikant geeft aan dat het realistische patiëntvolume 412 patiënten bedraagt.

Expected cost per patient per year

Cost 40,000.00 - 60,000.00
References Medicijnkosten.nl; EPAR
Additional remarks Verwacht in lijn met andere immunotherapieën. €1098,16 voor nivolumab 10mg per ml fl 10 ml; €3355,96 voor pembrolizumab 25 mg per ml fl 4ml. Berekening gebasseerd op EPAR.

Potential total cost per year

Total cost

26,400,000.00

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

Indication extension Yes
Indication extensions Nog voor veel indicaties in ontwikkeling; monotherapie en in combinatie met tremelimumab.

Other information

There is currently no futher information available.