Extended indication Treatment of patients with Newly Diagnosed Ph+ Chronic Myeloid Leukemia, 2L.
Therapeutic value No judgement
Total cost 6,042,036.00

Product

Active substance Bosutinib
Domain Oncology and Hematology
Main indication Leukemia
Extended indication Treatment of patients with Newly Diagnosed Ph+ Chronic Myeloid Leukemia, 2L.
Proprietary name Bosulif
Manufacturer Pfizer
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date July 2018
Expected Registration June 2018
Orphan drug Yes
Additional remarks Dit is een indicatie-uitbreiding.

Therapeutic value

Current treatment options Competitief met Imatinib generiek
Therapeutic value No judgement
Frequency of administration 4 times a day
Dosage per administration 100 mg

Expected patient volume per year

Patient volume

< 156

Market share is generally not included unless otherwise stated.

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
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

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.