Osimertinib Medicine 06 June 2023 Extended indication Extension of indication to include treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum based chemoradiation therapy. Therapeutic value No estimate possible yet Total cost € 11,121,300.00 Registration phase Registered and not reimbursed Product Active substance Osimertinib Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Extension of indication to include treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum based chemoradiation therapy. 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 May 2024 Expected Registration December 2024 Orphan drug No Registration phase Registered and not reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie november 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. DCO update: "LAURA study show that the median progression-free survival was 39.1 months with osimertinib and 5.6 months with placebo; the overall hazard ratio for disease progression or death was 0.16 (95% CI, 0.10 – 0.24; p < 0.001). Adverse events of grade 3 or higher were reported in 50 patients (35%) with osimertinib and 9 patients (12%) with placebo." Voorlopig positieve resultaten. Duration of treatment Frequency of administration 1 times a day Dosage per administration 80mg References NCT03521154 (LAURA, D5160C00048) 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