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Nintedanib

Vargatef

Extended indication Malignant pleural mesothelioma (MPM).
Therapeutic value No judgement
Total cost 7,206,500.00
Registration phase Clinical trials

Product

Active substance Nintedanib
Domain Oncology and Hematology
Main indication Mesothelioma
Extended indication Malignant pleural mesothelioma (MPM).
Proprietary name Vargatef
Manufacturer Boehringer Ingelheim
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks Tyrosine kinase inhibitor

Registration

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

Therapeutic value

Current treatment options Pemetrexed en cisplatin
Therapeutic value No judgement
Duration of treatment Average 10 month / months
Frequency of administration 2 times a day
Dosage per administration 200 mg
Additional remarks In combinatie met pemetrexed en cisplatin

Expected patient volume per year

Patient volume

213 - 284

Market share is generally not included unless otherwise stated.
References Fabrikant; NKR
Additional remarks NKR 2016: 567 diagnoses pleuramesothelioom. Hiervan is ~50% van epitheloid histologie en dus geschikt voor nintedanib (284 patiënten). Naar schatting (uit het veld) komt hiervan ongeveer 75% in aanmerking voor eerstelijnschemotherapie (213 patienten).

Expected cost per patient per year

Cost 25,000.00 - 33,000.00
References Fabrikant; G-standaard
Additional remarks Een capsule van 100mg kost €1.683 per maand; een capsule van 150mg kost €2.474,52 per maand.

Potential total cost per year

Total cost

7,206,500.00

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 Er lopen meerdere PhIII studies.

Other information

There is currently no futher information available.