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.

1. 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.

2. 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.

3. 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

4. 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.

5. 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.

6. 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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

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

9. Other information

There is currently no futher information available.