Extended indication Limited stage small cell lung cancer (LS-SCLC) following concurrent platinum-based chemotherapy and
Therapeutic value No estimate possible yet
Total cost 34,425,000.00
Registration phase Clinical trials

Product

Active substance Durvalumab
Domain Oncology
Reason of inclusion Indication extension
Main indication Lung cancer
Extended indication Limited stage small cell lung cancer (LS-SCLC) following concurrent platinum-based chemotherapy and radiation therapy in combination with Tremelimumab.
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 2023
Expected Registration 2024
Orphan drug No
Registration phase Clinical trials
Additional comments Voor durvalumab geldt tot eind 2023 een financieel arrangement voor oncologische indicaties.

Therapeutic value

Current treatment options No active treatment (observation)
Therapeutic value No estimate possible yet
Substantiation Er zijn nog geen resultaten van de ADRIATIC studie bekend.
Frequency of administration 1 times every 4 weeks
Dosage per administration Durvalumab 1500mg, tremelimumab 75mg (maximum of 4 doses)
References NCT03703297 (ADRIATIC)

Expected patient volume per year

Patient volume

< 510

Market share is generally not included unless otherwise stated.

References NKR2018 (1);
Additional comments In 2018 waren er 510 patiënten met kleincellig longcarcinoom in stadium 1,2 en 3. Mogelijk zal een gedeelte van deze patiëntengroep in aanmerking komen voor de behandeling.

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

34,425,000.00

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.