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Durvalumab

Imfinzi

Extended indication

Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer.
Therapeutic value

No estimate possible yet
Total cost

€ 25,980,480.00
Registration phase

Clinical trials

Product

Active substance

Durvalumab
Domain

Oncology and Hematology
Reason of inclusion

Indication extension
Main indication

Oncology other
Extended indication

Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer.
Proprietary name

Imfinzi
Manufacturer

AstraZeneca
Mechanism of action

PD-1 / PD-L1 inhibitor
Route of administration

Intravenous
Therapeutical formulation

Intravenous drip
Budgetting framework

Intermural (MSZ)

Registration

Registration route

Centralised (EMA)
Type of trajectory

Normal trajectory
ATMP

No
Submission date

2022
Expected Registration

2023
Orphan drug

No
Registration phase

Clinical trials
Additional comments 
Fabrikant verwacht indiening in het tweede kwartaal van 2022 en registratie in het tweede kwartaal van 2023. Voor durvalumab geldt tot eind 2023 een financieel arrangement voor oncologische indicaties.

Therapeutic value

Current treatment options

Chemotherapie
Therapeutic value

No estimate possible yet
Substantiation

Er zijn nog geen resultaten van de TOPAZ-1 studie bekend.
Frequency of administration

1 times every 3 weeks
Dosage per administration

1500mg
References 
NCT03875235 (TOPAZ-1).
Additional comments 
Behandelduur tot progressie. Toedieningsfrequentie 8 cycli van 3 weken met chemotherapie, daarna om de 4 weken.

Expected patient volume per year

Patient volume

< 248

Market share is generally not included unless otherwise stated.
References 
NKR
Additional comments 
Er zijn ongeveer 700 patiënten in Nederland gediagnosticeerd met een cholangiocarcinoom. Hiervan zijn er 248 patiënten met een stadium 4 carcinoom.

Expected cost per patient per year

Cost

€ 104,760.00
Additional comments 
De fabrikant geeft aan dat de prijs nog niet bekend is. Inschatting: De dosis durvalumab is 1.500mg. Toedieningsfrequentie 8 cycli van 3 weken met chemotherapie, daarna 1x per 4 weken. Prijs per toediening is dan (3 x €2.328)=€6.984. Aantal toedieningen 8 + 7 * €6.984 = €104.760 per jaar.

Potential total cost per year

Total cost

€ 25,980,480.00

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

There is currently nothing known about off label use.

Indication extension

Indication extension

No
References 
Fabrikant

Other information

There is currently no futher information available.