Extended indication Head and neck (or upper airways tract) cancers; squamous cell carcinoma of head or neck (SCCHN), 2L
Therapeutic value No judgement
Total cost 2,125,000.00
Registration phase Clinical trials

Product

Active substance Durvalumab / Tremelimumab
Domain Oncology and Hematology
Main indication Head and neck cancer
Extended indication Head and neck (or upper airways tract) cancers; squamous cell carcinoma of head or neck (SCCHN), 2L Durvalumab monotherapy in PDL1-positive tumours or in combination with Tremelimumab for PDL1-negative tumours.
Proprietary name Imfinzi / Tremelimumab
Manufacturer AstraZeneca
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Anti PD-L1 + anti CTLA-4

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Submission date 2018
Expected Registration 2019
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Op moment van registratie zijn er ook andere immunotherapieën beschikbaar voor deze indicatie.
Therapeutic value No judgement
Frequency of administration 1 times every 4 weeks
Dosage per administration 20 mg/kg / 1 mg/kg
References Fabrikant; NCT02369874
Additional remarks Toedingsfrequentie: Durvalumab 1 maal per 4 weken; Tremelimumab 1 maal per 4 weken met een maximum van 4 doses.

Expected patient volume per year

Patient volume

25 - 60

Market share is generally not included unless otherwise stated.

References Fabrikant; NKR
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). Fabrikant geeft aan dat er naar verwachting tussen de 21-29 patiënten behandeld zullen worden.

Expected cost per patient per year

Cost 40,000.00 - 60,000.00
References Medicijnkosten.nl
Additional remarks Verwacht in lijn met andere immunotherapieën. €1098,16 voor nivolumab 10mg per ml fl 10 ml; €3355,96 voor pembrolizumab 25 mg per ml fl 4ml.

Potential total cost per year

Total cost

2,125,000.00

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

Indication extension Yes
Indication extensions Nog voor veel indicaties in ontwikkeling, monotherapie en in combinatie met tremelimumab. Mogelijk ook 1L registratie.

Other information

There is currently no futher information available.