Paltusotine Medicine 04 June 2024 Extended indication Palsonify is indicated for the medical treatment of adult patients with acromegaly. Therapeutic value No estimate possible yet Total cost € 540,000,000.00 Registration phase Registered Product Active substance Paltusotine Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Metabolic diseases Extended indication Palsonify is indicated for the medical treatment of adult patients with acromegaly. Current proprietary name Already available biosimilars / generics Proprietary name Palsonify Manufacturer Crinetics Portfolio holder Mechanism of action 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 Normal trajectory Particularity ATMP No Submission date March 2025 Expected Registration April 2026 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in februari 2026 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 twee maar eenmaal daags oraal wordt toegediend 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 NCT04837040 (PATHFNDR-1); NCT05192382 (PATHFNDR-2) Additional remarks 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 € 150,000.00 - 750,000.00 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 Kosten op basis van IHSI-inschatting. Additional remarks De prijs in Nederland is nog niet bekend. In de VS is de prijs voor 60 20-mg tabletten $2.612,27. De prijs per dosis bedraagt daar dan $787,08. Dit betekent ongeveer $290.000 per jaar per patiënt. Potential total cost per year Total cost € 540,000,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks