Nintedanib Medicine 09 January 2018 Extended indication Malignant pleural mesothelioma (MPM). Therapeutic value No judgement Total cost € 7,221,000.00 Registration phase Clinical trials Product Active substance Nintedanib Domain Oncology and Hematology Reason of inclusion Main indication Mesothelioma Extended indication Malignant pleural mesothelioma (MPM). Current proprietary name Already available biosimilars / generics Proprietary name Vargatef Manufacturer Boehringer Ingelheim Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Tyrosine kinase inhibitor Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date September 2018 Expected Registration September 2019 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Pemetrexed en cisplatin Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 10 month / months Frequency of administration 2 times a day Dosage per administration 200 mg References 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. Maximum patient volume for sluice 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 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. 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 € 7,221,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Er lopen meerdere PhIII studies. References Additional remarks Other information Additional remarks