Extended indication

Unresectable locally advanced or metastatic urothelial cancer in combination with tremelimumab and c

Therapeutic value

No estimate possible yet

Total cost

47,250,000.00

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 comments
Anti PD-L1 + anti CTLA-4

Registration

Registration route

Centralised (EMA)

Type of trajectory

Normal trajectory

ATMP

No

Submission date

December 2022

Expected Registration

October 2023

Orphan drug

No

Registration phase

Clinical trials

Additional comments
Voor durvalumab geldt tot eind 2023 een financieel arrangement voor oncologische indicaties. Fabrikant verwacht indiening in het vierde kwartaal van 2022 en registratie in het vierde kwartaal van 2023.

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

< 700

Market share is generally not included unless otherwise stated.

References
NKR2018(1);
Additional comments
Er zijn 700 patiënten met gemetastaseerde blaaskanker in Nederland (1).

Expected cost per patient per year

Cost

45,000.00 - 90,000.00

Additional comments
De dosis durvalumab is 1.500mg elke 4 weken tot ziekteprogressie. Prijs per toediening is dan (3 x €2.328)=€6.984. Voor 6 maanden is dit 26/4 x €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-€90.000 bedragen uitgaande van 6 of 12 maanden behandeling. Deze kosten betreffen alleen durvalumab.

Potential total cost per year

Total cost

47,250,000.00

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.