Paltusotine Medicine 04 June 2024 Extended indication Treatment of Acromegalie Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Paltusotine Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Metabolic diseases Extended indication Treatment of Acromegalie Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Crinetics Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Werkingsmechanimse: Somatostatin receptor 2 agonists Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date December 2024 Expected Registration January 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks NCT05192382 Therapeutic value Current treatment options Octreolin Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Het is vergelijkbaar met niet leverbaar Octreolin. Het voordeel van dit middel is dat het niet 2 maar 1 maal daags oraal kan en waarschijnlijk minder voedsel afhankelijk is. Het voordeel van orale therapie versus maandelijkse injectie (intramuraal of subcutaan) waarvoor vaak ook thuiszorg geregeld moet worden. Duration of treatment Frequency of administration Dosage per administration References Additional remarks NCT05192382 Expected patient volume per year Patient volume < 1,200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks Het gaat om ongeveer 1.200 patiënten die een Somatostatine gebruiken (injecties) Expected cost per patient per year Cost References Additional remarks 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 Unknown Indication extensions References Additional remarks Other information Additional remarks