Durvalumab

Extended indication	Lokaal gevorderd, niet-resectabel NSCLC (stadium III)
Therapeutic value	No judgement
Total cost	55,518,750.00
Registration phase	Clinical trials

Product

Active substance	Durvalumab
Domain	Oncology and Hematology
Reason of inclusion	Indication extension
Main indication	Lung cancer
Extended indication	Lokaal gevorderd, niet-resectabel NSCLC (stadium III)
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 + CTLA-4 mAB

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Submission date	April 2021
Expected Registration	July 2022
Orphan drug	No
Registration phase	Clinical trials
Additional remarks	Fabrikant verwacht indiening in Q2 2021 en registratie in Q3 2022

Therapeutic value

Current treatment options	Chemotherapie, chemoradiatie.
Therapeutic value	No judgement
Frequency of administration	1 times every 4 weeks
Dosage per administration	1500 mg durvalumab
References	PACIFIC-2 (NCT03519971)

Expected patient volume per year

Patient volume	617 - 1,028 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 2016 waren er 2.056 stadium III patiënten met niet-kleincellig longcarcinoom. 30-50% van de patiënten met stadium IIIa en IIIb zal in aanmerking komen omdat het carcinoom niet resectabel blijkt. Dit betekent dat er maximaal 617 - 1.028 patiënten in aanmerking zullen komen.

Patient volume

617 - 1,028

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 2016 waren er 2.056 stadium III patiënten met niet-kleincellig longcarcinoom. 30-50% van de patiënten met stadium IIIa en IIIb zal in aanmerking komen omdat het carcinoom niet resectabel blijkt. Dit betekent dat er maximaal 617 - 1.028 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 1.500 mg 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. Voor durvalumab geldt per 1 september 2019 tot en met 31 oktober 2023 een financieel arrangement voor oncologische indicaties.

Potential total cost per year

Total cost	55,518,750.00 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

55,518,750.00

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.