Osimertinib Medicine 09 January 2018 Extended indication NSCLC EGFR mutation, 1L. subpopulatie van NSCLC 1L (EGFR-TKI-sensitizing en EGFR-T790M), de indicatie is afhankelijk van de studieresultaten. Therapeutic value No judgement Total cost € 388,252,800.00 Registration phase Unknown Product Active substance Osimertinib Domain Oncology and Hematology Reason of inclusion Main indication Lung cancer Extended indication NSCLC EGFR mutation, 1L. subpopulatie van NSCLC 1L (EGFR-TKI-sensitizing en EGFR-T790M), de indicatie is afhankelijk van de studieresultaten. 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 Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Dit is een indicatie-uitbreiding. 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 Frequency of administration 1 times a day Dosage per administration 80 mg References Additional remarks Fabrikant: Behandelduur is onbekend. Dosering is gebaseerd op: A randomized, phase III study (FLAURA) of AZD9291, a novel EGFR-TKI, versus gefitinib or erlotinib in treatment-naïve patients with advanced non-small cell lung cancer and an EGFR-TKI-sensitizing mutation. Expected patient volume per year Patient volume < 5,304 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Oncoline; Soria et al. N Engl J Med. 2017 Nov 18. doi: 10.1056/ Additional remarks Bij NSCLCs die resistentie ontwikkelen tegen EGFR-TKIs heeft >50% een EGFR-T790M mutatie. FLAURA studie laat beter PFS zien in vergelijking met standaard behandeling in eerstelijns patienten. Oncoline: Bij patiënten met stadium IV NSCLC en een activerende EGFR-mutatie leidt behandeling met EGFR-TKI's ongeacht de mate van voorbehandeling tot betere therapeutische resultaten dan behandeling met chemotherapie. NKR 2015: 5304 diagnoses NSCLC stadium 4. 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 € 388,252,800.00 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