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Durvalumab

Imfinzi

Extended indication Squamous cell carcinoma of the head and neck, 1L PDL 1.
Therapeutic value No judgement
Total cost 11,562,000.00
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, 1L PDL 1.
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 National (CBG)
Particularity Indication extension
Submission date 2019
Expected Registration 2020
Orphan drug No
Registration phase Clinical trials
Additional remarks Indicatie-uitbreiding

Therapeutic value

Current treatment options Carboplatin or cisplatin + 5FU + cetuximab
Therapeutic value No judgement
Frequency of administration 1 times every 4 weeks
Dosage per administration 1500 mg
References Seiwert et al. Journal of Clinical Oncology 2016 34:15_suppl, TPS6101-TPS6101 

Expected patient volume per year

Patient volume

47 - 235

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 21patiënten stadium I PCC, 1195 patiënten stadium II PCC, 52 patiënten stadium III PCC en 8 patiënten stadium IV PCC. De fabrikant geeft aan zelf realistisch 47 patiënten te verwachten en maximaal 235 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

11,562,000.00

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.