Extended indication Myelofibrosis
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Fedratinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Myeloproliferative disorders
Extended indication Myelofibrosis
Proprietary name Inrebic
Manufacturer Celgene
Mechanism of action JAK tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional comments JAK2 inhibitor

Registration

Registration route Centralised (EMA)
Submission date February 2020
Expected Registration March 2021
Registration phase Registration application pending
Additional comments In 2013 zijn de klinische studies door Sanofi stopgezet wegens ernstige bijwerkingen (Wernicke’s encephalopathie). Celgene heeft federatinib inmiddels opgekocht.

Therapeutic value

Current treatment options Ruxolitinib
Therapeutic value No judgement
Substantiation Milt verkleining, symptom score reduction
Frequency of administration 1 times a day
Dosage per administration 400 mg
References JAKARTA: NCT01437787 JAKARTA2: NCT01523171

Expected patient volume per year

Patient volume

20 - 143

Market share is generally not included unless otherwise stated.

References NKR
Additional comments 143 diagnoses in 2016. De inschatting van experts is 20 patiënten.

Expected cost per patient per year

References medicijnkosten.nl en gipdatabank.nl
Additional comments De kosten zullen mogelijk in dezelfde range komen te liggen als ruxolitinib, wat per tablet van 10 mg €64,80 kost (inclusief BTW). Uiteindelijke kosten per patiënt per jaar afhankelijk van de dosis en behandelduur. De kosten van ruxolitinib betroffen gemiddeld genomen bij de behandeling van myelofibrose zo'n €30.000 per patiënt per jaar.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension No
References adisinsight
Additional comments Geen lopende fase 3 studies.

Other information

There is currently no futher information available.