Bosutinib Medicine 09 January 2018 Extended indication Treatment of patients with Newly Diagnosed Ph+ Chronic Myeloid Leukemia, 2L. Therapeutic value No judgement Total cost € 6,042,036.00 Registration phase Unknown Product Active substance Bosutinib Domain Oncology and Hematology Reason of inclusion Main indication Leukemia Extended indication Treatment of patients with Newly Diagnosed Ph+ Chronic Myeloid Leukemia, 2L. Current proprietary name Already available biosimilars / generics Proprietary name Bosulif Manufacturer Pfizer Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date July 2018 Expected Registration June 2018 Orphan drug Yes Registration phase Unknown Reimbursement Medicine sluice Additional remarks Dit is een indicatie-uitbreiding. Therapeutic value Current treatment options Competitief met Imatinib generiek Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 4 times a day Dosage per administration 100 mg References Additional remarks Expected patient volume per year Patient volume < 156 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Nederlandse Vereniging voor Hematologie; Janssen et al. Ned Tijdschr Hematol 2014;11:185-98 Additional remarks NKR 2015: 164 CML diagnoses. 95% van CML is Ph+ (Nederlandse Vereniging voor Hematologie). Moet concurreren met imatinib, nilotinib en dasatinib maar lijkt niet signifikant beter. Expected cost per patient per year Cost € < 38,731.00 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 Gebaseerd op 400 mg per dag (4 maal 100 mg tabletten) en de huidige lijstprijs van €742,78 per 28 pillen van 100mg. Potential total cost per year Total cost € 6,042,036.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks