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Dasatinib

Sprycel

Extended indication Extension of Indication to include a paediatric indication for Philadelphia chromosome positive acut
Therapeutic value No judgement
Total cost 272,869.75
Registration phase Registration application pending

Product

Active substance Dasatinib
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Leukemia
Extended indication Extension of Indication to include a paediatric indication for Philadelphia chromosome positive acute lymphoblastic leukaemia for Sprycel.
Proprietary name Sprycel
Manufacturer BMS
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
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
Submission date November 2017
Expected Registration February 2018
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Overige TKIs, nilotinib, imatinib en bozutinib
Therapeutic value No judgement
Substantiation Wordt momenteel off-label voor deze indicatie verstrekt. Zal bij registratie verplaatsen naar on-label.
Duration of treatment continuous
Frequency of administration 1 times a day
Dosage per administration 140 mg
References Farmacotherapeutisch Kompas

Expected patient volume per year

Patient volume

11 - 20

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks Maximaal zo rond de 20 patiënten die in aanmerking zouden komen voor de behandeling. Cijfersoverkanker.nl laat zien een voorlopige schatting voor 2017 zien van 11 kinderen met B-ALL met specifieke cytogenetische afwijkingen.

Expected cost per patient per year

Cost 11,736.00 - 23,473.00
References Fabrikant; G-standaard
Additional remarks €64,31 per tablet conform G-standaard mei 2018. Inmiddels onderdeel van nationaal inkoopinitiatief.

Potential total cost per year

Total cost

272,869.75

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No

Other information

There is currently no futher information available.