Osimertinib Medicine 08 December 2020 Extended indication The adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. Therapeutic value Possible added value Total cost € 13,602,006.00 Registration phase Positive CHMP opinion Product Active substance Osimertinib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication The adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. 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 September 2020 Expected Registration June 2021 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in april 2021. Osimertinib is breed uitgesloten, deze nieuwe indicatie zal dan ook in de sluis worden geplaatst. Therapeutic value Current treatment options Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation De follow-up is nog niet lang genoeg en de overlevingsdata zullen laten nog op zich wachten. De progressievrije overleving lijkt positief te zijn. Duration of treatment Median 22.5 month / months Frequency of administration 1 times a day Dosage per administration 80 mg References ADAURA (NCT02511106), Wu et al. 2020 N Engl J Med 2020; 383:1711-1723 Additional remarks Expected patient volume per year Patient volume 132 - 264 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 2018 waren er 1.724 stadium I, 921 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 132 tot 264 patiënten in aanmerking zullen komen voor deze behandeling. Het patiëntvolume is afhankelijk van definitieve registratie en plaatsbepaling. Expected cost per patient per year Cost € 68,697.00 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 (Z-Index februari 2021). Additional remarks Lijstprijs van Tagrisso is €5.642,50 per 30 tabletten. =€5.642,50*(365,25/30) =€68.697,44 Potential total cost per year Total cost € 13,602,006.00 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