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Nilotinib

Tasigna

Extended indication Paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukae
Therapeutic value No judgement
Total cost 225,000.00

Product

Active substance Nilotinib
Domain Oncology and Hematology
Main indication Leukemia
Extended indication Paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase and paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.
Proprietary name Tasigna
Manufacturer Novartis
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Expected Registration September 2017
Orphan drug No
Additional remarks Geregistreerd in november 2017.

Therapeutic value

Therapeutic value No judgement
Duration of treatment Average 1 year / years
Frequency of administration 2 times a day
Dosage per administration 400 mg
Additional remarks De dosering bij pediatrische patiënten is gepersonaliseerd en gebaseerd op de lichaamsoppervlakte (mg/m2). De aanbevolen dosis van nilotinib is 230 mg/m2 tweemaal daags, afgerond naar de dichtstbijzijnde 50 mg dosis (tot een maximale enkelvoudige dosis van 400 mg). Gemiddelde behandelduur bedraagt 52,19 weken.

Expected patient volume per year

Patient volume

5 - 10

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks NKR: Chronische myeloproliferatieve aandoeningen bij kinderen: 56. Van alle myeloproliferatieve aandoeningen betreft 18 % CML. Maximale volume daarom geschat op: 10. Realistisch volume gescaht op: 5.

Expected cost per patient per year

Cost 10,000.00 - 50,000.00
References Fabrikant
Additional remarks Huidige AIP is €1010,93 voor Tasigna 150 mg (5x8) en €1296,80 voor Tasigna 200 mg (5x8).

Potential total cost per year

Total cost

225,000.00

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.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.