Extended indication Non-small cell lung cancer (NSCLC) stage III, unresectable.
Therapeutic value No judgement
Total cost 66,830,000.00
Registration phase Registration application pending

Product

Active substance Durvalumab
Domain Oncology and Hematology
Main indication Lung cancer
Extended indication Non-small cell lung cancer (NSCLC) stage III, unresectable.
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)
Type of trajectory Normal trajectory
Particularity New medicine
Submission date October 2017
Expected Registration November 2018
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Nivolumab, Pembrolizumab
Therapeutic value No judgement
Frequency of administration 1 times every 2 weeks
Dosage per administration 10 mg/kg
References Fabrikant; Antonia et al. N Engl J Med 2017;377:1919-29.

Expected patient volume per year

Patient volume

815

Market share is generally not included unless otherwise stated.

References NKR; Fabrikant
Additional remarks NKR 2015: NSCLC stadium 3: 2424 diagnoses. Fabrikant: realistisch volume bedraagt 815 patienten in 2019.

Expected cost per patient per year

Cost 82,000.00
References Fabrikant
Additional remarks Verwacht in lijn met andere immunotherapieën. Naar verwachting is de maandelijkse kostprijs vergelijkbaar met maandelijkse kostprijs van pembrolizumab (€6.810).

Potential total cost per year

Total cost

66,830,000.00

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.

Other information

There is currently no futher information available.