Extended indication Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Elective Invasive Procedures.
Therapeutic value No judgement
Registration phase Registration application pending

Product

Active substance Lusutrombopag
Domain Oncology and Hematology
Main indication Other hematology
Extended indication Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Elective Invasive Procedures.
Proprietary name Mulpleta
Manufacturer Shionogi
Mechanism of action Unknown
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks Thrombopoietin receptor agonists

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity New medicine
ATMP Unknown
Submission date February 2018
Expected Registration March 2019
Orphan drug No
Registration phase Registration application pending
Additional remarks L-PLUS-2 trail: effective and safe. Met all endpoints.

Therapeutic value

Therapeutic value No judgement

This assessment does not indicate any potential inclusion in the package.

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

Patient volume

Market share is generally not included unless otherwise stated.

References SPS; NHG-Standaard Virushepatitis en andere leveraandoeningen.
Additional remarks De incidentie van cirrose en andere leveraandoeningen in de huisartsenpraktijk is 0,6 per 1000 per jaar en de prevalentie 4,4 per 1000 per jaar. 76% van de cirrosepatiƫnten heeft thrombocytopenie. Dit betekent dat de totale incidentie 7.752 bedraagt en de prevalentie 56.848.

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use Unknown

Indication extension

Indication extensions Unknown

Other information