Fostamatinib

Active substance Fostamatinib
Domain Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)
Main indication Hematology other
Extended indication Tavlesse is indicated for the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments.

Product

Proprietary name Tavlesse
Manufacturer Rigel
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional comments Prodrug voor het actieve bestandsdeel tamatinib wat een remmer is van de tyrosinekinase Syk.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date October 2018
Expected Registration January 2020
Orphan drug No
Registration phase Registered
Additional comments Positieve CHMP-opinie in november 2019.

Therapeutic value

Therapeutic value No judgement
Substantiation 56% van de patiënten met een stabiele respons behielden die voor ten minste 24 maanden.
Duration of treatment Median 8.9 continuous
Frequency of administration 2 times a day
Dosage per administration 100 mg
References Bussel et al. Am J Hematol. 2018 Apr 26; ASH2018, paper No: 736

Expected patient volume per year

Patient volume

170 - 680

Market share is generally not included unless otherwise stated.

References Erfelijkheid.nl
Additional comments ITP komt bij ongeveer 1 tot 4 op de 100.000 mensen voor.

Expected cost per patient per year

Cost 13,000 - 29,000
References GIPdatabank
Additional comments Verwacht wordt dat de prijs in lijn ligt met de huidige therapieën. Eltrombopag kostte in 2016, €13.139 per patiënt per jaar. Romiplostim kostte in 2016 €28.998 per patiënt per jaar.

Potential total cost per year

Total cost

8,925,000

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 Yes
Indication extensions Warm antibody autoimmune hemolytic anemia (wAIHA)
References adisinsight
Additional comments Lopende fase 3 studie

Other information

There is currently no futher information available.