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Durvalumab

Imfinzi

Extended indication Completely resected NSCLC
Therapeutic value No estimate possible yet
Total cost 277,830,000.00
Registration phase Clinical trials

Product

Active substance Durvalumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Lung cancer
Extended indication Completely resected NSCLC
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 mAb

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date 2023
Expected Registration 2024
Orphan drug No
Registration phase Clinical trials
Additional remarks Voor durvalumab geldt tot eind 2023 een financieel arrangement voor oncologische indicaties. Fabrikant verwacht indiening in 2023 en registratie in 2024.

Therapeutic value

Current treatment options Geen (na operatie en eventueel chemotherapie)
Therapeutic value No estimate possible yet
Dosage per administration 1500 mg durvalumab
References BR31 (NCT02273375)

Expected patient volume per year

Patient volume

3,871 - 4,361

Market share is generally not included unless otherwise stated.
References NKR; Therapeutic management options for stage III non-small cell lung cancer. SM Yoon. 2017.
Additional remarks In 2018 waren er 1.724 patiënten in stadium 1, 921 patiënten in stadium II en 2.452 patiënten in stadium III met niet-kleincellig longcarcinoom. 30% tot 50% van de patiënten met stadium IIIa en IIIb zal afvallen omdat het carcinoom niet resectabel blijkt. Dit betekent dat er maximaal 3.871 tot 4.361 patiënten in aanmerking zullen komen.

Expected cost per patient per year

Cost 45,000.00 - 90,000.00
References Fabrikant
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

277,830,000.00

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.