Extended indication

Cabozantinib combined with atezolizumab in patients with metastatic non-small cell lung cancer previ

Therapeutic value

No estimate possible yet

Total cost

46,318,080.00

Registration phase

Clinical trials

Product

Active substance

Cabozantinib

Domain

Oncology

Reason of inclusion

Indication extension

Main indication

Lung cancer

Extended indication

Cabozantinib combined with atezolizumab in patients with metastatic non-small cell lung cancer previously treated with only 1 anti-PD-L1/PD-1 checkpoint-inhibitor and platinum-containing chemotherapy, either sequentially or concurrently (without a targetable oncogenic driver) for 2L or 3L (line depending on previous treatment regime)

Proprietary name

Cabometyx

Manufacturer

Ipsen

Portfolio holder

Ipsen

Mechanism of action

Tyrosine kinase inhibitor

Route of administration

Oral

Therapeutical formulation

Tablet

Budgetting framework

Intermural (MSZ)

Centre of expertise

Patients without actionable target mutations are currently treated in all lungcancer treating hospitals (no centralization in expert centers)

Registration

Registration route

Centralised (EMA)

Type of trajectory

Normal trajectory

ATMP

No

Submission date

December 2022

Expected Registration

October 2023

Orphan drug

No

Registration phase

Clinical trials

Therapeutic value

Current treatment options

2L: After 1L chemotherapy in combination with immunotherapy in 1L. SoC Docetaxel monotherapy 3L: After 2L Platinum doublet chemotherapy with option of pemetrexed maintenance if patients received immunotherapy mono in 1L 3L: After 2L Immunotherapy monotherapy (pembrolizumab, nivolumab, atezolizumab) if patient received chemotherapy mono in 1L

Therapeutic value

No estimate possible yet

Duration of treatment

Average 11 month / months

Frequency of administration

1 times a day

Dosage per administration

40mg

References
NCT04471428 (CONTACT-01)
Additional comments
Patiënten krijgen dagelijks 1 tablet 40mg cabozantinib gedurende 16 cycli van elk 21 dagen. Dit komt overeen met ongeveer 11 maanden behandeling.

Expected patient volume per year

Patient volume

< 652

Market share is generally not included unless otherwise stated.

References
NKR, 2019
https://iknl.nl/Kankersoorten/Longkanker/Registratie
Hendriks et.al 2020
Dutch Lung Cancer Audit 2019, CieBOM lorlatinib, maart 2022
Expert opinie
Additional comments
In 2019 waren er 9.944 diagnoses NSCLC in Nederland (NKR), waarvan 49% stadium IV (Hendriks et.al 2020). Dit komt overeen met 4.873 nieuwe patiënten. Hier komen nog patiënten bij uit eerdere stadia die verslechteren naar stadium IV. Volgens CieBOM ontwikkelt 40-50% van de patiënten die eerder in opzet curatief behandeld zijn in de loop van de tijd afstandsmetastasen (=stadium IV) (Dutch Lung Cancer Audit 2019, CieBOM lorlatinib, maart 2022).
In totaal bedraagt deze groep dus zo'n 7.155 patiënten. Hiervan heeft 50% geen actionable driver mutatie, 3.577 (NKR, 2019). Hiervan gaat 10% in klinische studies. Van de overige patiënten zonder mutatie zal maximaal 55% een eerstelijns behandeling ontvangen (1.771 patiënten, NKR). De patiëntenpopulatie die een behandeling ontvangt neemt met 50% per lijn af (expertopinie). Uitgaande van het huidige behandelalgoritme (gebruik IO/CT of combinatie therapie) resteren maximaal 419 potentiële patiënten in tweede lijn en 233 in derde lijn.

Expected cost per patient per year

Cost

< 71,040.00

References
AIP per april 2022 (source Z-Index) €5.874,26 per unit of 30 tablets. Based on 365 days of treatment, the maximum cost per patient per year is €71.470,16
Additional comments
Annual cost of atezolizumab use not included in calculation

Potential total cost per year

Total cost

46,318,080.00

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

Indication extension

Yes

Indication extensions

onderzocht voor veel verschillende indicaties in fase 2 en 3 op dit moment

References
AdisInsight

Other information

There is currently no futher information available.