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

Product

Active substance Afatinib
Domain Oncology and Hematology
Reason of inclusion Indication extension
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
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional comments Antineoplastische stoffen, proteïnekinaseremmers.

Registration

Registration route Centralised (EMA)
Orphan drug No
Registration phase No registration expected
Additional comments Al op de markt voor EGFR+ NSCLC, 1L en plaveiselcel NSCLC, 2L. De fabrikant geeft aan dat er geen registratie meer verwacht wordt.

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
References NCT01427478

Expected patient volume per year

References NKR 2015
Additional comments Hoofd-hals tumoren, stadium 3 en 4, respectievelijk 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
References G-standaard; Fabrikant
Additional comments De prijs van het middel dat nu al op de markt is voor NSCLC is €2.113,57 per maand.

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

Indication extension No
References clinicaltrials.gov

Other information

There is currently no futher information available.