Osimertinib Medicine 09 January 2018 Extended indication Monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. Therapeutic value No judgement Total cost € 23,497,200.00 Registration phase Registered and reimbursed Product Active substance Osimertinib Domain Oncology and Hematology Reason of inclusion Main indication Lung cancer Extended indication Monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. Current proprietary name Already available biosimilars / generics Proprietary name Tagrisso Manufacturer AstraZeneca Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Osimertinib binds irreversibly to epidermal growth factor receptor (EGFR) proteins with a T790M mutation, as well as EGFR proteins with a L858R mutation, and to EGFR proteins with an exon 19 deletion. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date 2017 Expected Registration June 2018 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve opinie CHMP april 2018. Tweedelijnsbehandeling reeds op de markt. Breakthrough Therapy granted by the FDA. Therapeutic value Current treatment options Eerstelijns Tyrosine Kinase Inhibitors (TKIs): Erlotinib, Gefitinib, Afatinib. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 16.2 month / months Frequency of administration 1 times a day Dosage per administration 80 mg References Soria, J. et al. N. Engl. J. Med. Online ahead of print (2017) Additional remarks Mediane behandelduur is 16,2 maanden. Expected patient volume per year Patient volume 214 - 428 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; NKR Additional remarks Volgens de IKNL cijfers was het aantal patiënten met NSCLC in 2015 9.546. Het aantal NSCLC patiënten met EGFR mutaties in 1L is ongeveer 5 tot 10%. Hiervan heeft 80% gemetastaseerde ziekte. In de praktijk zullen niet alle patiënten vanwege comorbiditeiten in aanmerking komen voor een behandeling, maar ongeveer 80%. Verder is het testgehalte voor mutaties volgens de PALGA database (van pathologen) 70%. Dit brengt het totale aantal patiënten op 214 tot 428 patiënten. Expected cost per patient per year Cost € 73,200.00 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 Berekening: 12 x €6.100 (huidige prijs van osimertinib per 30 dagen) = €73.200 p.p.p.j. max Potential total cost per year Total cost € 23,497,200.00 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