Lusutrombopag Medicine 12 June 2018 Extended indication Treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures. Therapeutic value No judgement Total cost Registration phase Registered Product Active substance Lusutrombopag Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Other hematology Extended indication Treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures. Current proprietary name Already available biosimilars / generics Proprietary name Lusutrombopag Shionogi Manufacturer Shionogi Portfolio holder Mechanism of action Receptor agonist Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Thrombopoietin receptor agonists Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date February 2018 Expected Registration February 2019 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks L-PLUS-2 trial: effectief en veilig. Heeft alle eindpunten gehaald. Positieve CHMP-opinie december 2018. Geregistreerd in februari 2019. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 7 day / days Frequency of administration 1 times a day Dosage per administration 3 mg References NCT02389621 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References SPS; NHG-Standaard Virushepatitis en andere leveraandoeningen. Additional remarks 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 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. References https://www.biopharmadive.com/news/shionogi-launches-cheaper-rival-to-dovas-doptelet/531516/ Additional remarks 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 Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks geen fase 3 studies voor andere indicaties dan in de Horizonscan Other information Additional remarks