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.