Lerodalcibep Medicine 03 December 2024 Extended indication Cardiovascular disorder in adults and elderly on a stable diet and oral LDL-C lowering drug therapy with history of CVD, monotherapy for add-on treatment. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Lerodalcibep Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Lipid-lowering medications Extended indication Cardiovascular disorder in adults and elderly on a stable diet and oral LDL-C lowering drug therapy with history of CVD, monotherapy for add-on treatment. Current proprietary name Already available biosimilars / generics Proprietary name LIB003 Manufacturer Lib Therapeutics Portfolio holder Mechanism of action Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks PCSK9-remmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date 2025 Expected Registration 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Primary completion (actual): 15 november 2023. Therapeutic value Current treatment options PCSK9-remmers (alirocumab, evolocumab), inclisiran. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Fase 3 LIBerate-CVD laat 55 tot 60% daling zien in LDL-C. Het is nog onduidelijk wat de meerwaarde is ten opzichte van huidige behandelopties. Duration of treatment Frequency of administration 1 times a month Dosage per administration 300mg References NCT04797247 (LIB003-005; LIBerate-CVD) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank. 2024 (1). Additional remarks In 2023 waren er 32.830 gebruikers van de PCSK9-remmers evolocumab en alirocumab. Er waren 1.574 gebruikers van inclisiran (1). De voorlopige verwachting is dat lerodalcibep geen groot deel van de markt gaat overnemen, omdat er nog geen duidelijke meerwaarde is ten opzichte van huidige behandelopties. Expected cost per patient per year Cost € 4,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Additional remarks Indien de kosten vergelijkbaar zijn met concurrent evolocumab (ook een PCSK9 protein inhibitor) zullen de kosten mogelijk rond de €4.000 per patiënt per jaar bedragen. 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