Dapansutrile Medicine 05 December 2023 Extended indication Acute Gout Flare Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Dapansutrile Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Rheumatism Extended indication Acute Gout Flare Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Olatec Portfolio holder Mechanism of action Interleukin inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date December 2023 Expected Registration January 2025 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Anakinra en canakunumab. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er lopen fase 3 studies (lopen nog 2 jaar). Er worden voorlopig nog geen resultaten verwacht. Op dit moment is hierdoor nog niet te zeggen hoe effectief het is en hoe het ingezet gaat worden. Er zijn al goedkope alternatieven. Op dit moment worden bijvoorbeeld anakinra en canakunumab gegeven. Duration of treatment Average 1 week / weeks Frequency of administration 2 times a day Dosage per administration 1000mg References NCT05658575 Additional remarks An initial loading dose of 2.000mg dapansutrile on Day 1 followed by a maintenance regimen of 1.000mg dapansutrile twice daily starting 12 hours later through the second dose on Day 7, inclusive. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References https://www.ntvg.nl/artikelen/jicht-4 Additional remarks De prevalentie varieert van 1% tot 7%. In Nederland waren er in 2017 bijna 500.000 mensen met jicht. 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