Osimertinib

Tagrisso

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.
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)

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.

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.

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