Rociletinib Medicine 09 January 2018 Extended indication EGFR positieve non-small cell lung cancer (NSCLC). Therapeutic value No judgement Total cost Registration phase Withdrawn Product Active substance Rociletinib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication EGFR positieve non-small cell lung cancer (NSCLC). Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Clovis Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Unknown 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trajectory Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase Withdrawn Reimbursement Medicine sluice Additional remarks Meerdere studies teruggetrokken, 1 PhIII studie loopt nog: Monotherapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC) After Failure of at Least 1 Previous EGFR-directed Tyrosine Kinase Inhibitor (TKI) and Platinum-doublet Chemotherapy. 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 Dosage per administration References Additional remarks Expected patient volume per year Patient volume 0 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Ned Tijdschr Geneeskd. 2011;155:A2554; Fabrikant; Pakketadvies Atezolizumab; PALGA database; Expertopinie 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. Fabrikant geeft aan dat de huidige studies worden stopgezet met uitzondering van de patiënten die momenteel baat hebben bij een behandeling. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks