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Durvalumab

Medicine

Extended indication Durvalumab monotherapy for adjuvant treatment of newly diagnosed Hepatocellular carcinoma in adults and elderly who are at high risk of recurrence aft
Total cost € 31,779,800.00
Registration phase Clinical trials

Product

Active substance Durvalumab
Domain Oncology
Reason of inclusion Indication extension IND
Main indication Liver cancer
Extended indication Durvalumab monotherapy for adjuvant treatment of newly diagnosed Hepatocellular carcinoma in adults and elderly who are at high risk of recurrence after curative hepatic resection or ablation
Proprietary name Imfinzi®
Manufacturer AstraZeneca
Portfolio holder 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
Particularity Indication extension
ATMP No
Submission date November 2026
Expected Registration November 2027
Orphan drug No
Registration phase Clinical trials
Additional remarks Indieningsdatum en verwachte registratie op basis van inschatting van de fabrikant.

Therapeutic value

Frequency of administration 1 times every 3 weeks
Dosage per administration 1120 mg
References NCT03847428

Expected patient volume per year

Patient volume 368 - 515

Market share is generally not included unless otherwise stated.
References 1: NKR 2022; 2: Substantial risk of recurrence even after 5 recurrence-free years in early-stage hepatocellular carcinoma patients., Kim et al., 2020; Adjuvant therapy for hepatocellular carcinoma: Dilemmas at the start of a new era., Zhong., 2024;
Additional remarks Er waren in 2022 in Nederland 736 patiënten waar een Hepatocellulair carcinoom (HCC )werd gediagnosticeerd. 66,7% van de HCC patiënten hebben een hoog risico op een recidief na curatieve resectie of ablatie (2). Ongeveer 50% tot 70% van de HCC patiënten ontvangen adjuvante therapie om het risico op recidief te verminderen (3).

Expected cost per patient per year

Cost € 71,900.00

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.
References medicijnkosten.nl; fabrikant
Additional remarks De prijs per 2,4 mL flacon (50mg/ml) durvalumab (Imfinzi) is €444. De jaarlijkse kosten worden ingeschat op €71.829.

Potential total cost per year

Total cost € 31,779,800.00

Off label use

Indication extension

Other information