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 comments 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 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.