Fedratinib

Active substance

Fedratinib

Domain

Oncology and Hematology

Reason of inclusion in Horizonscan Geneesmiddelen

New medicine (specialité)

Main indication

Myeloproliferative disorders

Extended indication
Myelofibrosis

1. Product

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

2. 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.

3. Therapeutic value

Current treatment options

Ruxolitinib

Therapeutic value

No judgement

Substantiation

Milt verkleining, symptom score reduction

Duration of treatment

Not found

Frequency of administration

1 times a day

Dosage per administration

400 mg

References
JAKARTA: NCT01437787
JAKARTA2: NCT01523171

4. 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.

5. 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.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension

No

References
adisinsight
Additional comments
Geen lopende fase 3 studies.

9. Other information

There is currently no futher information available.