Extended indication

Stage III unresectable Epidermal Growth Factor Receptor (EGFR) mutation positive non-small cell lung

Therapeutic value

No estimate possible yet

Total cost

11,121,368.04

Registration phase

Clinical trials

Product

Active substance

Osimertinib

Domain

Oncology

Reason of inclusion

Indication extension

Main indication

Lung cancer

Extended indication

Stage III unresectable Epidermal Growth Factor Receptor (EGFR) mutation positive non-small cell lung cancer (NSCLC)

Proprietary name

Tagrisso

Manufacturer

AstraZeneca

Portfolio holder

AstraZeneca

Mechanism of action

Tyrosine kinase inhibitor

Route of administration

Oral

Therapeutical formulation

Tablet

Budgetting framework

Intermural (MSZ)

Registration

Registration route

Centralised (EMA)

Type of trajectory

Normal trajectory

ATMP

No

Submission date

2023

Expected Registration

2024

Orphan drug

No

Registration phase

Clinical trials

Additional remarks
Fabrikant verwacht indiening in de 2023 en registratie in 2024.

Therapeutic value

Current treatment options

Actief volgen

Therapeutic value

No estimate possible yet

Substantiation

De LAURA studie loopt op dit moment nog.

Frequency of administration

1 times a day

Dosage per administration

80mg

References
LAURA (NCT03521154).

Expected patient volume per year

Patient volume

108 - 216

Market share is generally not included unless otherwise stated.

References
IKNL (1);  Pakketadvies sluisgeneesmiddel osimertinib (Tagrisso®) bij de eerstelijnsbehandeling van patiënten met gevorderde of gemetastaseerde niet-kleincellige longkanker (NSCLC) met activerende EGFR-mutaties (2)
Additional remarks
Aantal patiënten met NSCLC in 2020 stadium 3 betrof 2.163. (1) Het aantal NSCLC patiënten met EGFR betreft zo'n 5 tot 10% van deze patiënten (2)

Expected cost per patient per year

Cost

68,650.42

References
Prijs per 1 januari 2021 (Z-Index/G-standaard februari 2021)
Additional remarks
Berekening: €5.642,50 per 30 tabletten.
Komt neer op €5.642,50*(365/30) =€ 68.650,42 per patiënt per jaar. Voor osimertinib is een financieel arrangement afgesloten bij de indicaties "Niet eerder behandelde uitgezaaide EGFR-positieve longkanker (NSCLC)" en "Adjuvante behandeling bij EGFR-positieve longkanker (NSCLC)" die afloopt op 31 december 2025 (Staatscourant 2022, 5825).

Potential total cost per year

Total cost

11,121,368.04

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.