Osimertinib

Extended indication	Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care Chemotherapy Alone for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer
Therapeutic value	No estimate possible yet
Registration phase	Clinical trials

Product

Active substance	Osimertinib
Domain	Oncology
Reason of inclusion	Indication extension
Main indication	Lung cancer
Extended indication	Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care Chemotherapy Alone for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer
Proprietary name	Tagrisso
Manufacturer	AstraZeneca
Portfolio holder	AstraZeneca
Mechanism of action	Tyrosine kinase inhibitor
Route of administration	Oral
Therapeutical formulation	Capsule
Budgetting framework	Intermural (MSZ)

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
ATMP	No
Submission date	2024
Expected Registration	September 2025
Orphan drug	No
Registration phase	Clinical trials

Therapeutic value

Therapeutic value	No estimate possible yet
Substantiation	Er zijn nog geen studie resultaten bekend.

Expected patient volume per year

Patient volume	119 - 237 Market share is generally not included unless otherwise stated.
References	NKR2022 (1); Expertopinie (2); Pakketadvies sluisgeneesmiddel osimertinib (Tagrisso®) bij de eerstelijnsbehandeling van patiënten met gevorderde of gemetastaseerde niet-kleincellige longkanker (NSCLC) met activerende EGFR-mutaties (3).
Additional remarks	In 2022 werden er in Nederland 2.372 mensen met niet-kleincellig longcarcinoom, stadium I en II, gediagnosticeerd (1). 70% betreft adenocarcinoom (2). Het aantal NSCLC patiënten met EGFR betreft zo'n 5 tot 10% van deze patiënten (3).

Patient volume

119 - 237

Market share is generally not included unless otherwise stated.

References

NKR2022 (1); Expertopinie (2); Pakketadvies sluisgeneesmiddel osimertinib (Tagrisso®) bij de eerstelijnsbehandeling van patiënten met gevorderde of gemetastaseerde niet-kleincellige longkanker (NSCLC) met activerende EGFR-mutaties (3).

Additional remarks

In 2022 werden er in Nederland 2.372 mensen met niet-kleincellig longcarcinoom, stadium I en II, gediagnosticeerd (1). 70% betreft adenocarcinoom (2). Het aantal NSCLC patiënten met EGFR betreft zo'n 5 tot 10% van deze patiënten (3).

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

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.