Lusutrombopag

Active substance
Lusutrombopag
Domain
Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Hematology other
Extended indication
Treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures.

1. Product

Proprietary name
Lusutrombopag Shionogi
Manufacturer
Shionogi
Mechanism of action
Receptor agonist
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Intermural (MSZ)
Additional comments
Thrombopoietin receptor agonists

2. Registration

Registration route
Centralised (EMA)
Submission date
February 2018
Expected Registration
February 2019
Orphan drug
No
Registration phase
Registered
Additional comments
L-PLUS-2 trial: effectief en veilig. Heeft alle eindpunten gehaald. Positieve CHMP-opinie december 2018. Geregistreerd in februari 2019.

3. Therapeutic value

Therapeutic value
No judgement
Duration of treatment
Average 7 day / days
Frequency of administration
1 times a day
Dosage per administration
3 mg
References
NCT02389621

4. Expected patient volume per year

References
SPS; NHG-Standaard Virushepatitis en andere leveraandoeningen.
Additional comments
De incidentie van cirrose en andere leveraandoeningen in de huisartsenpraktijk is 0,6 per 1.000 per jaar en de prevalentie 4,4 per 1.000 per jaar. 76% van de cirrosepatiënten heeft thrombocytopenie. Dit betekent dat de totale incidentie 7.752 bedraagt en de prevalentie 56.848.

5. Expected cost per patient per year

Cost
7,000 - 8,000
References
https://www.biopharmadive.com/news/shionogi-launches-cheaper-rival-to-dovas-doptelet/531516/
Additional comments
Sionogi heeft bekendgemaakt in de Verenigde Staten een prijs van $8,500 te hanteren voor een 7-daagse behandeling (~€7.700).

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
Additional comments
geen fase 3 studies voor andere indicaties dan in de Horizonscan

9. Other information

There is currently no futher information available.