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Osimertinib

Tagrisso

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 2024
Expected Registration 2025
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.