Durvalumab

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 remarks	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 remarks	In 2018 waren er 5.062 patiënten met NSCLC stadium IV. Hiervan zal 60% een eerstelijnsbehandeling krijgen (3.037).

Patient volume

< 3,037

Market share is generally not included unless otherwise stated.

References

NKR 2015; Pakketadvies atezolizumab.

Additional remarks

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 remarks	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.

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.