Dasatinib Medicine 09 January 2018 Extended indication Chronic myelogenous leukaemia (CML), newly diagnosed chronic phase, or philadelphia positive leukemias resistant or intolerant to imatinib - in children (aged 1-18 years). Therapeutic value No judgement Total cost € 140,000.00 Registration phase Unknown Product Active substance Dasatinib Domain Oncology and Hematology Reason of inclusion Main indication Leukemia Extended indication Chronic myelogenous leukaemia (CML), newly diagnosed chronic phase, or philadelphia positive leukemias resistant or intolerant to imatinib - in children (aged 1-18 years). Current proprietary name Already available biosimilars / generics Proprietary name Sprycel Manufacturer BMS 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 May 2017 Expected Registration September 2018 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Dit is een indicatie-uitbreiding. Geen geregistreerde kinderindicatie, off label indicaties reeds opgenomen in add-on lijst en kinderformularium. Therapeutic value Current treatment options Overige Tyrosine Kinase Inhibitors (TKIs) (velen zijn reeds generiek). Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 60-80 mg/m2 References Aplenc et al. J Clin Oncol., 2011, Mar 1;29(7), 839-44; Matloub et al, Clinical Trial Protocol CA180226; Zwaan et al. J Clin Oncol., 2013, Jul 1;31(19), 2460-8; Watanabe et al. Pediatr Int., 2013, Jun;55(3), e56-8 Additional remarks Behandelduur Ph+ ALL: 2-3 jaar; behandelduur CML: chronisch gebruik (3 jaar tot levenslang). 60-80 mg/m2, max 140-180 mg Expected patient volume per year Patient volume 3 - 5 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 20,000.00 - 50,000.00 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 Medicijnkosten.nl Additional remarks Tablet Dasatinib 100 mg is €130,80. Inschatting kosten pppj uitgaande van de volgende aanname: 50 tot 100 mg 1 maal per dag voor een jaar. Potential total cost per year Total cost € 140,000.00 Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Prostate cancer, hormone-refractory disease in combination with doxetaxel (PhIII). References Additional remarks Other information Additional remarks