Extended indication

Limited stage small cell lung cancer (LS-SCLC) following concurrent platinum-based chemotherapy and

Therapeutic value

No estimate possible yet

Total cost

34,425,000.00

Registration phase

Clinical trials

Product

Active substance

Durvalumab

Domain

Oncology

Reason of inclusion

Indication extension

Main indication

Lung cancer

Extended indication

Limited stage small cell lung cancer (LS-SCLC) following concurrent platinum-based chemotherapy and radiation therapy in combination with Tremelimumab.

Proprietary name

Imfinzi

Manufacturer

AstraZeneca

Portfolio holder

AstraZeneca

Mechanism of action

PD-1 / PD-L1 inhibitor

Route of administration

Intravenous

Therapeutical formulation

Intravenous drip

Budgetting framework

Intermural (MSZ)

Additional remarks
Anti PD-L1 + anti CTLA-4

Registration

Registration route

Centralised (EMA)

Type of trajectory

Normal trajectory

ATMP

No

Submission date

2024

Expected Registration

2025

Orphan drug

No

Registration phase

Clinical trials

Additional remarks
Voor tremulimumab geldt dat deze in de sluis is geplaatst voor zover verstrekt in het kader van geneeskundige behandelingen: https://zoek.officielebekendmakingen.nl/stcrt-2023-8134.html

Therapeutic value

Current treatment options

No active treatment (observation)

Therapeutic value

No estimate possible yet

Substantiation

Er zijn nog geen resultaten van de ADRIATIC studie bekend.

Frequency of administration

1 times every 4 weeks

Dosage per administration

Durvalumab 1500mg, tremelimumab 75mg (maximum of 4 doses)

References
NCT03703297 (ADRIATIC)

Expected patient volume per year

Patient volume

< 510

Market share is generally not included unless otherwise stated.

References
NKR2018 (1);
Additional remarks
In 2018 waren er 510 patiënten met kleincellig longcarcinoom in stadium 1,2 en 3. Mogelijk zal een gedeelte van deze patiëntengroep in aanmerking komen voor de behandeling.

Expected cost per patient per year

Cost

45,000.00 - 90,000.00

Additional remarks
De dosis durvalumab is 1.500mg elke 4 weken tot ziekteprogressie. 
Prijs per toediening is dan 3x€2.328=€6.984. 
Voor 6 maanden is dit 26/4x€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 en €90.000 bedragen uitgaande van 6 of 12 maanden behandeling. Deze kosten betreffen alleen durvalumab.

Potential total cost per year

Total cost

34,425,000.00

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.