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Durvalumab

Imfinzi

Extended indication Squamous cell carcinoma of the head and neck, 2L
Therapeutic value No judgement
Total cost 2,460,000.00
Registration phase Clinical trials

Product

Active substance Durvalumab
Domain Oncology and Hematology
Main indication Head and neck cancer
Extended indication Squamous cell carcinoma of the head and neck, 2L
Proprietary name Imfinzi
Manufacturer AstraZeneca
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks PD-L1 remmer

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Cetuximab, taxane, methotrexate, or fluoropyrimidine. Zal moeten gaan concurreren met Nivolumab.
Therapeutic value No judgement
Frequency of administration 1 times every 2 weeks
Dosage per administration 10 mg/kg
References Ferris et al. Journal for ImmunoTherapy of Cancer 2015, 3(Suppl 2):P150

Expected patient volume per year

Patient volume

0 - 60

Market share is generally not included unless otherwise stated.
References NKR, Fabrikant.
Additional remarks PCC hoofd en nek in totaal in 2016 6814 patiënten (NKR). Hiervan hebben er 52 patiënten stadium III PCC en 8 patiënten stadium IV PCC (dus in totaal 60 patiënten). De fabrikant geeft aan zelf realistisch 0 patiënten te verwachten en maximaal 29 patiënten.

Expected cost per patient per year

Cost 82,000.00
References Fabrikant; Pakketadvies pembrolizumab (Keytruda®) 2016 Zorginstituut Nederland
Additional remarks Naar verwachting is de maandelijkse kostprijs vergelijkbaar met maandelijkse kostprijs van pembrolizumab (€6.810)

Potential total cost per year

Total cost

2,460,000.00

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.

Off label use

Off label use No

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.