Osimertinib Medicine 06 June 2023 Extended indication Osimertinib in combination with pemetrexed and platinum based chemotherapy for locally advanced (clinical stage IIIB, IIIC) or metastatic Non-Small Cell Lung Cancer (NSCLC) (clinical stage IVA or IVB) or recurrent Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy. Therapeutic value No estimate possible yet Total cost € 5,148,750.00 Registration phase Registered Product Active substance Osimertinib Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Osimertinib in combination with pemetrexed and platinum based chemotherapy for locally advanced (clinical stage IIIB, IIIC) or metastatic Non-Small Cell Lung Cancer (NSCLC) (clinical stage IVA or IVB) or recurrent Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy. 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 September 2023 Expected Registration June 2024 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Osimertinib Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De FLAURA2 studie loopt op dit moment nog. Er is nog geen consensus over welke groep in Nederland hiervoor in aanmerking komt. Duration of treatment Frequency of administration 1 times a day Dosage per administration Osimertinib 80mg in combination with pemetrexed (500mg/m2) plus cisplatin (75mg/m2) or carboplatin (AUC5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Osimertinib daily with pemetrexed maintenance (500mg/m2) every 3 weeks. References FLAURA2 (NCT04035486). Additional remarks Expected patient volume per year Patient volume 50 - 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2018 (1); Pakketadvies sluisgeneesmiddel atezolizumab (Tecentriq®) bij gemetastaseerde niet-kleincellige longkanker. ZIN. 2018 (2); Concurrent EGFR Mutation and ALK Translocation in Non-Small Cell Lung Cancer (3); Expertopinie (4). Additional remarks In 2018 waren er 10.190 diagnoses NSCLC in Nederland. Dit betrof 1.724 stadium I, 921 stadium II, 2.452 stadium III (waarvan zo'n 55% stadium IIIa en zo'n 45% stadium IIIb), 5.062 stadium IV en 31 onbekend. Uitgaande van stadium IIIb/IV komt dat neer op zo'n 6.165 patiënten (1). Hier komen nog patiënten bij uit eerdere stadia die verslechteren naar stadium IIIb/IV. Binnen een jaar is de inschatting dat dit 20% van stadium I/II bedraagt (529 patiënten) en 50% van stadium IIIa (674 patiënten). In totaal bedraagt deze groep dus zo'n 7.369 patiënten (2). Het aantal NSCLC patiënten met EGFR betreft zo'n 5 tot 10% van deze patiënten (3). De schatting is echter dat er ongeveer 50 tot 100 patiënten in aanmerking komen voor deze behandeling (4). 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 € 5,148,750.00 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