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.