Extended indication

The adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-smal

Therapeutic value

Possible added value

Total cost

13,602,093.12

Registration phase

Positive CHMP opinion

Product

Active substance

Osimertinib

Domain

Oncology and Hematology

Reason of inclusion

Indication extension

Main indication

Lung cancer

Extended indication

The adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.

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

September 2020

Expected Registration

June 2021

Orphan drug

No

Registration phase

Positive CHMP opinion

Additional comments
Positieve CHMP-opinie in april 2021. Osimertinib is breed uitgesloten, deze nieuwe indicatie zal dan ook in de sluis worden geplaatst.

Therapeutic value

Therapeutic value

Possible added value

Substantiation

De follow-up is nog niet lang genoeg en de overlevingsdata zullen laten nog op zich wachten. De progressievrije overleving lijkt positief te zijn.

Duration of treatment

Median 22.5 month / months

Frequency of administration

1 times a day

Dosage per administration

80 mg

References
ADAURA (NCT02511106), Wu et al. 2020 N Engl J Med 2020; 383:1711-1723

Expected patient volume per year

Patient volume

132 - 264

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 2018 waren er 1.724 stadium I, 921 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 132 tot 264 patiënten in aanmerking zullen komen voor deze behandeling. Het patiëntvolume is afhankelijk van definitieve registratie en plaatsbepaling.

Expected cost per patient per year

Cost

68,697.44

References
Prijs per 1 januari (Z-Index februari 2021).
Additional comments
Lijstprijs van Tagrisso is €5.642,50 per 30 tabletten. =€5.642,50*(365,25/30) =€68.697,44

Potential total cost per year

Total cost

13,602,093.12

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.