Osimertinib Medicine 08 December 2020 Extended indication Extension of indication of Tagrisso to include the adjuvant treatment after complete tumour resection in EGFR mutant non-small cell lung cancer (NSCLC) patients. Therapeutic value No judgement Total cost € 13,915,600.00 Registration phase Clinical trials Product Active substance Osimertinib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Extension of indication of Tagrisso to include the adjuvant treatment after complete tumour resection in EGFR mutant non-small cell lung cancer (NSCLC) patients. Current proprietary name Already available biosimilars / generics Proprietary name Tagrisso Manufacturer AstraZeneca Portfolio holder 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 Unknown Submission date December 2020 Expected Registration September 2021 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht indiening Q4 2020 en registratie in het tweede/derde kwartaal 2021 Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 80 mg References ADAURA (NCT02511106) Additional remarks Expected patient volume per year Patient volume 126 - 253 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Therapeutic management options for stage III non-small cell lung cancer. SM Yoon. 2017. Additional remarks In 2016 waren er 1.699 stadium I, 830 stadium II patiënten met niet-kleincellig longcarcinoom. (Stadium III patiënten wordt geen resectie op gedaan in Nederland). Het aantal NSCLC patiënten met EGFR mutaties in de eerstelijn is ongeveer 5%-10%. Dit betekent dat er uiteindelijk 126-253 patiënten in aanmerking zullen komen voor deze behandeling. Expected cost per patient per year Cost € 73,240.00 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 Fabrikant Additional remarks Lijstprijs van Tagrisso is €6.100 per 30 tabletten. =€6.100*(365/30,4) =€73.240. Potential total cost per year Total cost € 13,915,600.00 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