Osimertinib Medicine 09 January 2018 Extended indication 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 Possible added value Total cost € 23,058,000.00 Registration phase Registered Product Active substance Osimertinib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication 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 Normal trajectory Particularity Unknown ATMP Unknown Submission date 2017 Expected Registration June 2018 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve opinie CHMP april 2018. Tweedelijnsbehandeling reeds op de markt. Breakthrough Therapy granted by the FDA. Tagrisso wordt vergoed voor 2L EGFR T790M NSCLC. Het advies van ZIN is gedateerd op 7 november 2018. Osimertinib zit voor de 1e lijns indicatie in de sluis. Therapeutic value Current treatment options Eerstelijns Tyrosine Kinase Inhibitors (TKIs): erlotinib, Gefitinib, afatinib. Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation FLAURA studie Duration of treatment Average 18.9 month / months Frequency of administration 1 times a day Dosage per administration 80 mg References SmPC tekst, fabrikant. Additional remarks De gemiddelde behandelduur betreft 18,9 maanden en de mediaan 10,2 maanden. Expected patient volume per year Patient volume 210 - 420 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Pakketadvies Atezolizumab; Ned Tijdschr Geneeskd. 2011;155:A2554; expertopinie; PALGA database Additional remarks Jaarlijks presenteren er ongeveer 7.500 patiënten per jaar met NSCLC stadium IIIb/IV. Het aantal NSCLC patiënten met EGFR mutaties in 1L is ongeveer 5 tot 10% (375-750). In de praktijk zullen niet alle patiënten vanwege comorbiditeiten in aanmerking komen voor een behandeling, maar ongeveer 80% (300-600). Verder is het testgehalte voor mutaties volgens de PALGA database 70%. Dit brengt het totale aantal patiënten op 210 tot 420. 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 €6.100,00 (huidige prijs van osimertinib per 30 dagen) = €73.200,00 p.p.p.j. max. Prijs op basis van toepassing in tweede lijn, prijs in eerste lijn op dit moment onderdeel van de sluisonderhandeling. Potential total cost per year Total cost € 23,058,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions adjuvant EGFRm non-small cell lung cancer References Fabrikant; NCT02511106 Additional remarks Other information Additional remarks