Durvalumab

Extended indication	Extension of indication to include IMFINZI in combination with chemotherapy for the treatment of adults with locally advanced or metastatic biliary tract cancer (BTC).
Therapeutic value	No estimate possible yet
Total cost	25,980,480.00
Registration phase	Registration application pending

Product

Active substance	Durvalumab
Domain	Oncology
Reason of inclusion	Indication extension
Main indication	Oncology other
Extended indication	Extension of indication to include IMFINZI in combination with chemotherapy for the treatment of adults with locally advanced 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	February 2023
Orphan drug	No
Registration phase	Registration application pending
Additional remarks	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 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.

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.

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.