Extended indication Treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasiv
Therapeutic value No judgement
Registration phase Registered

Product

Active substance Lusutrombopag
Domain Oncology and Hematology
Reason of inclusion New medicine (specialit├ę)
Main indication Other hematology
Extended indication Treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures.
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 cirrosepati├źnten heeft thrombocytopenie. Dit betekent dat de totale incidentie 7.752 bedraagt en de prevalentie 56.848.

Expected cost per patient per year

There is currently nothing known about the expected cost.

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 III studies voor andere indicaties dan in de horizonscan

Other information

There is currently no futher information available.