Extended indication

Osimertinib in combination with pemetrexed and platinum based chemotherapy for locally advanced (cl

Therapeutic value

No estimate possible yet

Total cost

37,963,682.26

Registration phase

Positive CHMP opinion

Product

Active substance

Osimertinib

Domain

Oncology

Reason of inclusion

Indication extension

Main indication

Lung cancer

Extended indication

Osimertinib in combination with pemetrexed and platinum based chemotherapy for locally advanced (clinical stage IIIB, IIIC) or metastatic Non-Small Cell Lung Cancer (NSCLC) (clinical stage IVA or IVB) or recurrent Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.

Proprietary name

Tagrisso

Manufacturer

AstraZeneca

Portfolio holder

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

ATMP

No

Submission date

September 2023

Expected Registration

August 2024

Orphan drug

No

Registration phase

Positive CHMP opinion

Additional remarks
Positieve CHMP opinie mei 2024

Therapeutic value

Current treatment options

Osimertinib

Therapeutic value

No estimate possible yet

Substantiation

De FLAURA2 studie loopt op dit moment nog.

Frequency of administration

1 times a day

Dosage per administration

Osimertinib 80 mg in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Osimertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.

References
FLAURA2 (NCT04035486).

Expected patient volume per year

Patient volume

369 - 737

Market share is generally not included unless otherwise stated.

References
NKR2018 (1); Pakketadvies sluisgeneesmiddel atezolizumab (Tecentriq®) bij gemetastaseerde niet-kleincellige longkanker. ZIN. 2018 (2); Concurrent EGFR Mutation and ALK Translocation in Non-Small Cell Lung Cancer (3);
Additional remarks
In 2018 waren er 10.190 diagnoses NSCLC in Nederland. Dit betrof 1.724 stadium I, 921 stadium II, 2.452 stadium III (waarvan zo'n 55% stadium IIIa en zo'n 45% stadium IIIb), 5.062 stadium IV en 31 onbekend. Uitgaande van stadium IIIb/IV komt dat neer op zo'n 6.165 patiënten (1). Hier komen nog patiënten bij uit eerdere stadia die verslechteren naar stadium IIIb/IV. Binnen een jaar is de inschatting dat dit 20% van stadium I/II bedraagt (529 patiënten) en 50% van stadium IIIa (674 patiënten). In totaal bedraagt deze groep dus zo'n 7.369 patiënten (2). Het aantal NSCLC patiënten met EGFR betreft zo'n 5 tot 10% van deze patiënten (3)

Expected cost per patient per year

Cost

68,650.42

References
Prijs per 1 januari 2021 (Z-Index/G-standaard februari 2021)
Additional remarks
Berekening: €5.642,50 per 30 tabletten. Komt neer op €5.642,50*(365/30)=€ 68.650,42 per patiënt per jaar. 
Voor osimertinib is een financieel arrangement afgesloten bij de indicaties "Niet eerder behandelde uitgezaaide EGFR-positieve longkanker (NSCLC)" en "Adjuvante behandeling bij EGFR-positieve longkanker (NSCLC)" die afloopt op 31 december 2025 (Staatscourant 2022, 5825).

Potential total cost per year

Total cost

37,963,682.26

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.