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.