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Osimertinib

Tagrisso

Extended indication

Extension of indication of Tagrisso to include the adjuvant treatment after complete tumour resectio

Therapeutic value

No judgement
Total cost

€ 13,878,980.00
Registration phase

Clinical trials

Product

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.
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
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

€ 13,878,980.00

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.