Nintedanib Medicine 09 January 2018 Extended indication Mesothelioom Therapeutic value No judgement Total cost € 15,475,000.00 Registration phase Unknown Product Active substance Nintedanib Domain Oncology and Hematology Reason of inclusion Main indication Mesothelioma Extended indication Mesothelioom 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 Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration August 2019 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Dit is een indicatie-uitbreiding. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment 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 < 619 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks NKR 2016: 619 diagnoses pleuramesothelioom Expected cost per patient per year Cost € 20,000.00 - 30,000.00 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 Additional remarks 100mg=€1.683 p/m; 150mg=€2.524p/m Potential total cost per year Total cost € 15,475,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown 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