Enlicitide decanoate Medicine 03 June 2025 Extended indication Indicated in adults with primary hypercholesterolaemia or mixed dyslipidaemia. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Enlicitide decanoate Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Lipid-lowering medications Extended indication Indicated in adults with primary hypercholesterolaemia or mixed dyslipidaemia. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer MSD Portfolio holder Mechanism of action 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 ATMP No Submission date March 2026 Expected Registration April 2027 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Verwachte registratie op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT06450366 (CORALreef AddOn); NCT05952869 (CORALreef HeFH) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks De prijs is nog niet bekend. De prijs per patiënt per jaar voor een andere behandeloptie binnen deze indicatie bedraagt €1,299 nirmatrelvir/ritonavir (Paxlovid). Potential total cost per year Total cost 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