Afatinib Medicine 09 January 2018 Extended indication Head and neck (or upper airways tract) cancers, locally advanced (recurrent/metastatic) squamous cell, 2nd line after platinum therapy Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Afatinib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Head and neck cancer Extended indication Head and neck (or upper airways tract) cancers, locally advanced (recurrent/metastatic) squamous cell, 2nd line after platinum therapy Current proprietary name Already available biosimilars / generics Proprietary name Giotrif Manufacturer Boehringer Ingelheim Portfolio holder Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks antineoplastische stoffen, proteïnekinaseremmers Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Al op de markt voor EGFR+ NSCLC, 1L en plaveiselcel NSCLC, 2L. Fabrikant geeft aan dat het niet bekend is wanneer dit geneesmiddel ingediend zal worden. Verwachte indieningsdatum en verwachte registratiedatum op basis van estimated primary completion date fase 3 studie in november 2021. Therapeutic value Current treatment options Methotrexate. Andere immunotherapiën en PD1/PDL1-remmers. 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 40 mg References NCT01427478 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2015 Additional remarks Hoofd-hals tumoren, stadium 3 en 4, respectivelijk 427 en 1.189 (in totaal 1.616). Gezien het gaat om een 2L behandeling en gezien de huidige behandelopties / concurrentie zal het realistisch patiëntvolume lager liggen. Expected cost per patient per year Cost € 25,000.00 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 G-standaard; Fabrikant Additional remarks De prijs van het middel dat nu al op de markt is voor NSCLC is €2113,57 per maand. 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 geen fase III studies voor andere indicaties dan in de horizonscan References clinicaltrials.gov Additional remarks Other information Additional remarks