Cabozantinib Medicine 07 December 2022 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) Therapeutic value No estimate possible yet Total cost € 46,318,080.00 Registration phase No registration expected Product Active substance Cabozantinib Domain Oncology Reason of inclusion Indication extension IND 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) Current proprietary name Already available biosimilars / generics 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) Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Er zal geen EMA submissie plaatsvinden. In de fase III studie CONTACT-01 (cabozantinib + atezolizumab in tweede en derde lijns patiënten met mNSCLC) het primaire eindpunt van overall survival (OS) is niet behaald. 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 This assessment does not indicate any potential inclusion in the package. Substantiation 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. Maximum patient volume for sluice 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 tot 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 potentiële patiënten in derde lijn. Expected cost per patient per year Cost € < 71,040.00 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. 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 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions onderzocht voor veel verschillende indicaties in fase 2 en 3 op dit moment References AdisInsight Additional remarks Other information Additional remarks