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Plerixafor

Mozobil

Extended indication Extension of Indication to include paediatric patients aged 1 to 18 years. Mozobil is a medicine use
Therapeutic value No judgement
Total cost 33,000.00
Registration phase Registration application pending

Product

Active substance Plerixafor
Domain Oncology and Hematology
Reason of inclusion Indication extension
Main indication Lymphoma
Extended indication Extension of Indication to include paediatric patients aged 1 to 18 years. Mozobil is a medicine used to help collecting haematopoietic stem cells (cells in the bone marrow that can develop into different types of blood cells) for transplantation. It is used in adult patients with lymphoma or multiple myeloma (types of blood cell cancer) for autologous transplantation (when the patient’s own cells are used in the transplant). It is only used in patients in whom collection of stem cells is difficult.
Proprietary name Mozobil
Manufacturer Genzyme
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Alpha chemokine receptor CXCR4 antagonist.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date March 2018
Expected Registration February 2019
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Therapeutic value No judgement
Duration of treatment Average 4 day / days
Frequency of administration 1 times a day
Dosage per administration 0,24 mg/kg
References EPAR
Additional remarks Plerixafor dient 6 tot 11 uur vóór aanvang van elke aferese te worden toegediend door middel van een subcutane injectie, na een voorbehandeling van 4 dagen met G-CSF. Bij klinische onderzoeken werd plerixafor meestal gedurende 2 tot 4 (en tot maximaal 7) opeenvolgende dagen gebruikt.

Expected patient volume per year

Patient volume

3

Market share is generally not included unless otherwise stated.
References GIPdatabank; CBS
Additional remarks In 2015 werden 11 volwassenen behandeld met plerixafor. De verhouding van 1-18 jarigen ten opzichte van 18+ in Nederland in 2017 was 1:3,7. Dit zou betekenen dat er 3 kinderen in aanmerking zouden komen voor deze indicatie-uitbreiding.

Expected cost per patient per year

Cost < 11,000.00
References GIPdatabank; EPAR
Additional remarks In 2015 werd er €10.648 vergoed per gebruiker van plerixafor. Aangezien plerixafor per kg lichaamsgewicht wordt toegediend zullen de kosten per patiënt per jaar wellicht iets lager uitvallen.

Potential total cost per year

Total cost

33,000.00

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

Indication extension No

Other information

There is currently no futher information available.