Enlicitide decanoate Medicine 03 June 2025 Extended indication Enlicitide decanoate monotherapy for add-on treatment of heterozygous familial hypercholesterolaemia in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Enlicitide decanoate Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Lipid-lowering medications Extended indication Enlicitide decanoate monotherapy for add-on treatment of heterozygous familial hypercholesterolaemia in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer MSD Portfolio holder Mechanism of action Unknown 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 2026 Expected Registration 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn 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 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 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