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Durvalumab

Imfinzi

Extended indication Imfinzi as monotherapy is indicated for the first line treatment of adults with advanced or unresect
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
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP-opinie oktober 2023, registratie in november 2023

Therapeutic value

Current treatment options Durvalumab in combinatie met 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 2 en 179 in stadium 3 (1).

Expected cost per patient per year

Cost 45,000.00 - 90,000.00
References Andere indicaties voor Durvalumab
Additional remarks De mediane behandelduur in de studie was 5,5 maand. https://pmc.ncbi.nlm.nih.gov/articles/PMC9396100/ https://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.TPS4144 https://www.annalsofoncology.org/article/S0923-7534(24)00049-8/fulltext Dosering conform SMPC is 1.500 elke vier weken tot aan progressie. 1 flacio durva is 500ml dus per cycle 3 flacons = €6.984 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.

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.