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 € 48,480,000.00 Registration phase Unknown Product Active substance Afatinib Domain Oncology and Hematology Reason of inclusion 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 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 2021 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Dit is een indicatie-uitbreiding. Al op de markt voor EGFR+ NSCLC, 1L en plaveiselcel NSCLC, 2L. 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 Additional remarks Expected patient volume per year Patient volume < 1,616 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks NKR 2015: Hoofd-hals tumoren, stadium 3 en 4, respectivelijk 427 en 1189 Expected cost per patient per year Cost € < 30,000.00 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 Medicijnkosten.nl; Fabrikant Additional remarks Meerkosten. Huidige kosten giotrif: per tablet van 20/30/40/50mg is het €82,86. Meerkosten t.o.v. MTX. Fabrikant geeft aan dat Afatinib €26.256 pppj kost. Potential total cost per year Total cost € 48,480,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks