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Osimertinib

Tagrisso

Extended indication Extension of indication to include treatment of adult patients with locally advanced, unresectable N
Therapeutic value No estimate possible yet
Total cost 11,121,368.04
Registration phase Positive CHMP opinion

Product

Active substance Osimertinib
Domain Oncology
Reason of inclusion Indication extension
Main indication Lung cancer
Extended indication Extension of indication to include treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum based chemoradiation therapy.
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 May 2024
Expected Registration January 2025
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP opinie november 2024

Therapeutic value

Current treatment options Actief volgen
Therapeutic value No estimate possible yet
Substantiation De LAURA studie loopt op dit moment nog. DCO update: "LAURA study show that the median progression-free survival was 39.1 months with osimertinib and 5.6 months with placebo; the overall hazard ratio for disease progression or death was 0.16 (95% CI, 0.10 – 0.24; p < 0.001). Adverse events of grade 3 or higher were reported in 50 patients (35%) with osimertinib and 9 patients (12%) with placebo." Voorlopig positieve resultaten.
Frequency of administration 1 times a day
Dosage per administration 80mg
References NCT03521154 (LAURA, D5160C00048)

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.