Version 15

Durvalumab

Medicine

Extended indication Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cy
Therapeutic value No estimate possible yet
Total cost € 14,682,500.00
Registration phase Registered

Product

Active substance Durvalumab
Domain Oncology
Reason of inclusion Indication extension IND
Main indication Bladder cancer
Extended indication Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).
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)
Additional remarks PD-L1 remmer

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date November 2024
Expected Registration July 2025
Orphan drug Yes
Registration phase Registered
Medicine sluice Broadly excluded
Additional remarks Positieve CHMP-opinie in mei 2025.

Therapeutic value

Current treatment options Chemotherapie en immuuntherapie
Therapeutic value No estimate possible yet

This assessment does not indicate any potential inclusion in the package.
Substantiation Bij patiënten met spierinvasieve blaaskanker liet de NIAGARA studie zien dat toevoeging van durvalumab aan de behandeling resulteerde in een duidelijk betere uitkomst: na 24 maanden was de event-free survival 67,8% versus 59,8% in de controlegroep (HR 0,68; p < 0,001), wat neerkomt op een 32% lager risico op progressie, recidief, geen cystectomie of overlijden. Ook de overall survival verbeterde significant: 82,2% versus 75,2% (HR 0,75; p = 0,01), wat een 25% lager overlijdensrisico betekent.
Frequency of administration 1 times every 4 weeks
Dosage per administration 1.500mg
References NCT03732677 (NIAGARA); Powles et al. NEJM. 2024.
Additional remarks Neo-adjuvant 4 cycli, adjuvant q4w 8 cycli.

Expected patient volume per year

Patient volume 150 - 200

Market share is generally not included unless otherwise stated.
References IKNL 2021; Fabrikant; experts werkgroepen
Additional remarks In 2021 waren er 6.821 diagnoses blaaskanker. Fabrikant geeft aan dat het realistische patiëntvolume 412 patiënten bedraagt. De experts verwachten vergelijkbare patiëntvolumes zoals bij pembrolizumab met dezelfde indicatie, te weten 150 tot 200 patiënten.

Expected cost per patient per year

Cost € 83,900.00

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 fabrikant; G-standaard https://www.annalsofoncology.org/action/showPdf?pii=S0923-7534%2824%2903907-3
Additional remarks Dosering neo-adjuvant betreft 1.500mg intraveneus driewekelijkse dosering (in combi met cis-gem) voor vier cyclus gevolgd door adjuvant 1.500mg intraveneus vier-wekelijkse dosering voor acht cyclus. Dus 4+8=12 cyclus (1 flacon durvalumab is 500ml dus per cycli 3 flacons = €6.984 Twaalf cyclus is dan €83.808 (op basis van apothekersinkoopprijs).

Potential total cost per year

Total cost € 14,682,500.00

Off label use

Off label use No

Indication extension

Indication extensions Yes
Indication extensions Buiten de indicaties in de Horizonscan Geneesmiddelen voor meerdere indicaties in ontwikkeling: Biliary cancer; Cervical cancer; Fallopian tube cancer; Head and neck cancer; Liver cancer; Ovarian cancer; Peritoneal cancer; Renal cell carcinoma; Solid tumours.
References adisinsight
Additional remarks Fase 3

Other information