Osimertinib

Active substance

Osimertinib

Domain

Oncology and Hematology

Reason of inclusion

Indication extension

Main indication

Lung cancer

Extended indication
Extension of indication of Tagrisso to include the adjuvant treatment after complete tumour resection in EGFR mutant non-small cell lung cancer (NSCLC) patients.

Product

Proprietary name

Tagrisso

Manufacturer

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

Submission date

December 2020

Expected Registration

September 2021

Orphan drug

No

Registration phase

Clinical trials

Additional comments
Fabrikant verwacht indiening Q4 2020 en registratie in het tweede/derde kwartaal 2021

Therapeutic value

Therapeutic value

No judgement

Duration of treatment

Not found

Frequency of administration

1 times a day

Dosage per administration

80 mg

References
ADAURA (NCT02511106)

Expected patient volume per year

Patient volume

126 - 253

Market share is generally not included unless otherwise stated.

References
NKR; Therapeutic management options for stage III non-small cell lung cancer. SM Yoon. 2017.
Additional comments
In 2016 waren er 1.699 stadium I, 830 stadium II patiënten met niet-kleincellig longcarcinoom. (Stadium III patiënten wordt geen resectie op gedaan in Nederland). Het aantal NSCLC patiënten met EGFR mutaties in de eerstelijn is ongeveer 5%-10%. Dit betekent dat er uiteindelijk 126-253 patiënten in aanmerking zullen komen voor deze behandeling.

Expected cost per patient per year

Cost

73,240.00

References
Fabrikant
Additional comments
Lijstprijs van Tagrisso is €6.100 per 30 tabletten.  =€6.100*(365/30,4) =€73.240.

Potential total cost per year

Total cost

13,878,980

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.