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 remarks 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 remarks 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 remarks 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.