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 comments 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 comments 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 comments 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 comments 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.

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.