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Afatinib

Giotrif

Extended indication Head and neck (or upper airways tract) cancers, locally advanced (recurrent/metastatic) squamous cel
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance Afatinib
Domain Oncology and Hematology
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
Proprietary name Giotrif
Manufacturer Boehringer Ingelheim
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks antineoplastische stoffen, proteïnekinaseremmers

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Expected Registration 2021
Orphan drug No
Registration phase Clinical trials
Additional remarks 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
Frequency of administration 1 times a day
Dosage per administration 40 mg

Expected patient volume per year

References NKR
Additional remarks NKR 2015: Hoofd-hals tumoren, stadium 3 en 4, respectivelijk 427 en 1189 (in totaal 1616). 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 30,000.00
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

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.