Amivantamab Medicine 05 December 2023 Extended indication Amivantamab in combination with carboplatin and pemetrexed for the first‑line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating EGFR Exon 20 insertion mutations. Therapeutic value No estimate possible yet Total cost € 5,989,200.00 Registration phase Positive CHMP opinion Product Active substance Amivantamab Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Amivantamab in combination with carboplatin and pemetrexed for the first‑line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating EGFR Exon 20 insertion mutations. Current proprietary name Already available biosimilars / generics Proprietary name Rybrevant Manufacturer Janssen Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Injection liquid Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Amivantamab is een bispecifiek antilichaam gericht tegen EGFR en cMet. Registration Registration route Unknown Type of trajectory Unknown Particularity Unknown ATMP No Submission date October 2023 Expected Registration August 2024 Orphan drug Unknown Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie april 2024 Therapeutic value Current treatment options chemotherapie Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Positieve fase 3 studie resultaten en gaat de PASKWIL criteria halen. Duration of treatment Frequency of administration Dosage per administration zie opmerkingenveld References ClinicalTrials.gov Identifier: NCT04538664 (PAPILLON) Additional remarks Patients receive: - amivantamab 1,400mg (1,750 mg if body weight is >=80 kilogram [kg]) by IV infusion once weekly up to Cycle 2 Day 1, then 1,750mg (2,100mg if body weight is >=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3. -pemetrexed, administered as 500mg/m^2 IV infusion on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression. -Carboplatin, administered as AUC 5 IV infusion for up to 4 cycles on Day 1 of each 21-day cycle. Expected patient volume per year Patient volume < 62 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021; Pakketadvies sluisgeneesmiddel atezolizumab (Tecentriq®) bij gemetastaseerde niet-kleincellige longkanker, ZIN 2018; uitgezaaide-kanker-in-beeld-rapport.pdf; Pakketadvies sluisgeneesmiddel osimertinib (Tagrisso®) bij de eerstelijnsbehandeling van patiënten met gevorderde of gemetastaseerde niet-kleincellige longkanker (NSCLC) met activerende EGFR-mutaties; https://doi.org/10.1038/s41392-019-0038-9; uitgezaaide-kanker-in-beeld-rapport.pdf Additional remarks In 2021 waren er 10.096 diagnoses NSCLC in Nederland. Dit betrof 1.727 patiënten in stadium I, 822 patiënten in stadium II, 2.231 patiënten in stadium III, 5.247 patiënten in stadium IV. Uitgaande van stadium III/IV komt dat neer op zo'n 7.478 patiënten. Hier komen nog patiënten bij uit eerdere stadia die verslechteren naar stadium III/IV. Binnen een jaar is de inschatting dat dit 20% van stadium I/II bedraagt (510 patiënten). In totaal bedraagt deze groep dus zo'n 7.988 patiënten. Het aantal patiënten dat geen plaveiselcelcarcinoom heeft betreft 77% (ongeveer 6.151). Het aantal NSCLC patiënten met EGFR betreft zo'n 5 tot 10% van deze patiënten, hiervan heeft zo'n 4 tot 10% exon20 inserties (maximaal 62 patiënten). Expected cost per patient per year Cost € < 96,600.00 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 Z-index/G-standaard januari 2024 (1) Zhou C, Tang KJ, Byoung Chul Cho, Liu B, Paz‐Ares L, Cheng SY, et al. Amivantamab plus Chemotherapy in NSCLC with EGFR Exon 20 Insertions. The New England Journal of Medicine. 2023 Oct 21; (2) Additional remarks De Apotheekinkoopprijs (AIP) per vial amivantamab (Rybrevant) (350mg per vial) is €96.600,38 (1). Op basis van de dosering en gemiddelde behandelduur op basis van PFS van 11,4 maanden zijn de verwachte kosten per patiënt €101,648,42 (2). Potential total cost per year Total cost € 5,989,200.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks