Durvalumab

Extended indication	Imfinzi as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).
Therapeutic value	No estimate possible yet
Total cost	23,490,000.00
Registration phase	Registered

Product

Active substance	Durvalumab
Domain	Oncology
Reason of inclusion	Indication extension
Main indication	Liver cancer
Extended indication	Imfinzi as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).
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	2023
Expected Registration	December 2023
Registration phase	Registered
Additional remarks	Posititve CHMP-opinie oktober 2023 registratie in november 2023

Therapeutic value

Current treatment options	Durvalumab icm tremelimumab, atezolizumab-bevacizumab
Therapeutic value	No estimate possible yet
Substantiation	Het studiedesign is ingewikkeld. Op dit moment wordt de combinatie van atezolizumab-bevacizumab veel gegeven aan deze patiënten. Het is niet duidelijk welke behandeling effectiever is.
Dosage per administration	1500mg
References	NCT03298451

Expected patient volume per year

Patient volume	< 348 Market share is generally not included unless otherwise stated.
References	(1) NKR 2021
Additional remarks	Totaal aantal nieuwe HCC-patiënten in 2021 per jaar 787 patiënten. Hiervan bevonden zich er 169 in stadium II en 179 in stadium III (1).

Patient volume

< 348

Market share is generally not included unless otherwise stated.

References

(1) NKR 2021

Additional remarks

Totaal aantal nieuwe HCC-patiënten in 2021 per jaar 787 patiënten. Hiervan bevonden zich er 169 in stadium II en 179 in stadium III (1).

Expected cost per patient per year

Cost	45,000.00 - 90,000.00
References	Andere indicaties voor Durvalumab
Additional remarks	Afhankelijk van de behandelduur zal de prijs per jaar tussen de €45.000 en €90.000 bedragen uitgaande van 6 of 12 maanden behandeling.

Potential total cost per year

Total cost	23,490,000.00 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.

Total cost

23,490,000.00

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

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.