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.

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

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.

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

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.

Expected cost per patient per year

Cost 7,000.00 - 8,000.00
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).

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

Other information

There is currently no futher information available.