Obicetrapib / ezetimibe Medicine 04 December 2025 Extended indication Obicetrapib/ezetimibe monotherapy for adjunctive treatment of Heterozygous familial hypercholesterolaemia in adults and elderly with atherosclerotic cardiovascular disease whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Obicetrapib / ezetimibe Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Lipid-lowering medications Extended indication Obicetrapib/ezetimibe monotherapy for adjunctive treatment of Heterozygous familial hypercholesterolaemia in adults and elderly with atherosclerotic cardiovascular disease whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-modifying therapies Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Menarini Benelux Portfolio holder Mechanism of action Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks CETP-remmer / cholesterol absorptieremmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date June 2026 Expected Registration June 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 De resultaten van de REMBRANDT trial zijn nog niet bekend. Duration of treatment Frequency of administration 1 times a day Dosage per administration 10mg /10mg References NCT06005597 (TANDEM); Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks Als de fixed-dose combinatie even veel gaat kosten als obicetrapib alleen, dan zullen veel gebruikers van obicetrapib mogelijk deze vorm gaan gebruiken. Afhankelijk van de resultaten uit de Tamdem studie zou het ook kunnen dat met name patiënten met statine intolerantie in aanmerking zullen komen. 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks