Extended indication 1L advanced NSCLC
Therapeutic value No estimate possible yet
Total cost 204,997,500.00
Registration phase Clinical trials

Product

Active substance Durvalumab
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Lung cancer
Extended indication 1L advanced 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)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date July 2021
Expected Registration July 2022
Orphan drug No
Registration phase Clinical trials
Additional comments De fabrikant verwacht indiening in de eerste helft van 2021. Voor durvalumab geldt tot eind 2023 een financieel arrangement voor oncologische indicaties.

Therapeutic value

Current treatment options Chemotherapie
Therapeutic value No estimate possible yet
Dosage per administration 1500mg
References PEARL (NCT03003962)

Expected patient volume per year

Patient volume

< 3,037

Market share is generally not included unless otherwise stated.

References NKR 2015; Pakketadvies atezolizumab.
Additional comments In 2018 waren er 5.062 patiënten met NSCLC stadium IV. Hiervan zal 60% een eerstelijnsbehandeling krijgen (3.037).

Expected cost per patient per year

Cost 45,000.00 - 90,000.00
References Fabrikant
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

204,997,500.00

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.