Obicetrapib / ezetimibe Medicine 04 December 2025 Extended indication Treatment of primary hypercholesterolaemia or mixed dyslipidaemia. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Obicetrapib / ezetimibe Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Lipid-lowering medications Extended indication Treatment of primary hypercholesterolaemia or mixed dyslipidaemia. 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 August 2025 Expected Registration September 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 1 times a day Dosage per administration 10mg /10mg References NCT06005597 (TANDEM); NCT06305559 (REMBRANDT) 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks