Osimertinib Medicine 03 December 2024 Extended indication Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care Chemotherapy Alone for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer (NeoADAURA). Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Osimertinib Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care Chemotherapy Alone for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer (NeoADAURA). 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 Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date June 2026 Expected Registration December 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Broadly excluded Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen studieresultaten bekend. Duration of treatment Frequency of administration Dosage per administration References NCT04351555 (NeoADAURA) Additional remarks Expected patient volume per year Patient volume 119 - 237 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2022 (1); Expertopinie (2); Pakketadvies sluisgeneesmiddel osimertinib (Tagrisso®) bij de eerstelijnsbehandeling van patiënten met gevorderde of gemetastaseerde niet-kleincellige longkanker (NSCLC) met activerende EGFR-mutaties (3). Additional remarks In 2022 werden er in Nederland 2.372 mensen met niet-kleincellig longcarcinoom, stadium 1 en 2, gediagnosticeerd (1). 70% betreft adenocarcinoom (2). Het aantal NSCLC patiënten met EGFR betreft zoʼn 5 tot 10% van deze patiënten (3). Expected cost per patient per year Cost References Prijs per 1 januari 2021 (Z-Index/G-standaard februari 2021) Additional remarks €5.642,50 per 30 tabletten. 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 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks