Dasatinib Medicine 09 January 2018 Extended indication Indicated for the treatment of paediatric patients with newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. Therapeutic value No judgement Total cost € 336,600.00 Registration phase Positive CHMP opinion Product Active substance Dasatinib Domain Oncology and Hematology Reason of inclusion Main indication Leukemia Extended indication Indicated for the treatment of paediatric patients with newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. 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 Tyrosine kinase inhibitor. Dit product is onderdeel van het gezamenlijk inkoop verband dure geneesmiddelen NVZ/NFU/ZN Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Indication extension ATMP Unknown Submission date April 2017 Expected Registration July 2018 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve opinie CHMP april 2018. De CHMP heeft ook een nieuwe formulering voor kinderen goedgekeurd. 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 4 - 15 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Inschatting fabrikant 15 patiënten. Experts verwachten echter nog minder patiënten, realistisch 4 patiënten. Expected cost per patient per year Cost € 22,440.00 - 44,880.00 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 Prijs per tablet = €122,96 conform G-standaard mei 2018. Inmiddels onderdeel van een nationaal inkoopinitiatief. Potential total cost per year Total cost € 336,600.00 Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks