Osimertinib Medicine 06 June 2023 Extended indication Stage III unresectable Epidermal Growth Factor Receptor (EGFR) mutation positive non-small cell lung cancer (NSCLC) Therapeutic value No estimate possible yet Total cost € 11,121,300.00 Registration phase Clinical trials Product Active substance Osimertinib Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Stage III unresectable Epidermal Growth Factor Receptor (EGFR) mutation positive non-small cell lung cancer (NSCLC) Current proprietary name Already available biosimilars / generics 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) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2023 Expected Registration 2024 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht indiening in de 2023 en registratie in 2024. Therapeutic value Current treatment options Actief volgen Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De LAURA studie loopt op dit moment nog. Duration of treatment Frequency of administration 1 times a day Dosage per administration 80mg References LAURA (NCT03521154). Additional remarks Expected patient volume per year Patient volume 108 - 216 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL (1); Pakketadvies sluisgeneesmiddel osimertinib (Tagrisso®) bij de eerstelijnsbehandeling van patiënten met gevorderde of gemetastaseerde niet-kleincellige longkanker (NSCLC) met activerende EGFR-mutaties (2) Additional remarks Aantal patiënten met NSCLC in 2020 stadium 3 betrof 2.163. (1) Het aantal NSCLC patiënten met EGFR betreft zo'n 5 tot 10% van deze patiënten (2) Expected cost per patient per year Cost € 68,650.00 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 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 € 11,121,300.00 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