Extended indication Unresectable locally advanced or metastatic urothelial cancer in combination with tremelimumab and c
Therapeutic value No estimate possible yet
Total cost 30,982,500.00
Registration phase Clinical trials

Product

Active substance Durvalumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Bladder cancer
Extended indication Unresectable locally advanced or metastatic urothelial cancer in combination with tremelimumab and chemotherapy
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)
Additional remarks Anti PD-L1 + anti CTLA-4

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2024
Expected Registration 2025
Orphan drug No
Registration phase Clinical trials
Additional remarks Fabrikant verwacht indiening in 2024 en registratie in 2025. Voor tremulimumab geldt dat deze in de sluis is geplaatst voor zover verstrekt in het kader van geneeskundige behandelingen: https://zoek.officielebekendmakingen.nl/stcrt-2023-8134.html

Therapeutic value

Current treatment options Chemotherapie. Positief cieBOM advies voor avelumab onderhoudsbehandeling na stabiele ziekte op chemotherapie.
Therapeutic value No estimate possible yet
Substantiation Er zijn nog geen resultaten van de NILE studie bekend.
Dosage per administration Durvalumab 1500mg, tremelimumab 75mg (maximum of 4 doses)
References NCT03682068 (NILE)

Expected patient volume per year

Patient volume

< 459

Market share is generally not included unless otherwise stated.

References NKR2021(1);
Additional remarks Er zijn 459 patiënten met gemetastaseerde blaaskanker in Nederland (1).

Expected cost per patient per year

Cost 45,000.00 - 90,000.00
Additional remarks De dosis durvalumab is 1.500mg elke 4 weken tot ziekteprogressie. Prijs per toediening is dan (3x€2.328)=€6.984. Voor 6 maanden is dit 26/4x€6.984=€45.396; Voor 52 weken is dit 52/4x€6.984=€90.792. In de studie wordt durvalumab onderzocht als monotherapie en in combinatie met tremelimumab. Afhankelijk van de behandelduur zal de prijs per jaar tussen de €45.000 en €90.000 bedragen uitgaande van 6 of 12 maanden behandeling. Deze kosten betreffen alleen durvalumab.

Potential total cost per year

Total cost

30,982,500.00

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.