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Durvalumab

Imfinzi

Extended indication

Imfinzi in combination with gemcitabine and cisplatin is indicated for the first‑line treatment of a

Therapeutic value

Possibly no place in the treatment regimen
Total cost

25,980,480.00
Registration phase

Positive CHMP opinion

Product

Active substance

Durvalumab
Domain

Oncology
Reason of inclusion

Indication extension
Main indication

Oncology other
Extended indication

Imfinzi in combination with gemcitabine and cisplatin is indicated for the first‑line treatment of adults with unresectable or metastatic biliary tract cancer (BTC).
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

April 2022
Expected Registration

January 2023
Orphan drug

No
Registration phase

Positive CHMP opinion
Additional remarks 
Positieve CHMP-opinie november 2022. Voor durvalumab geldt tot eind 2023 een financieel arrangement voor oncologische indicaties.

Therapeutic value

Current treatment options

Chemotherapie
Therapeutic value

Possibly no place in the treatment regimen
Substantiation

De resultaten uit de TOPAZ-1 studie zijn bekend.De hazard ratio voor overall survival was 0,80 (95% confidence interval [CI], 0.66 to 0.97; P=0.021). Er wordt op basis van dit resultaat niet aan de paskwil-criteria voldaan.
Frequency of administration

1 times every 3 weeks
Dosage per administration

1500mg
References 
NCT03875235 (TOPAZ-1).
Additional remarks 
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 remarks 
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 remarks 
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.