Lerodalcibep Medicine 03 December 2024 Extended indication Is indicated in adults with primary hypercholesterolaemia (heterozygous familial (HeFH) and non-familial) or mixed dyslipidaemia as an adjunct to diet. Therapeutic value Possible equal value Total cost € 288,000,000.00 Registration phase Registration application pending Product Active substance Lerodalcibep Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Lipid-lowering medications Extended indication Is indicated in adults with primary hypercholesterolaemia (heterozygous familial (HeFH) and non-familial) or mixed dyslipidaemia as an adjunct to diet. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Lib Therapeutics Portfolio holder Mechanism of action Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks LDL-C is one of the major modifiable, and clinically validated, risk factors for atherosclerotic cardiovascular disease (CVD). Lerodalcibep binds specifically to proprotein convertase subtilisin/kexin type 9 (PCSK9) in the blood stream and blocks it from attaching to the LDLR, increasing low density lipoprotein receptor (LDLR) recycling, increasing LDL-C clearance, and lowering LDL-C. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date May 2025 Expected Registration July 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Primary completion datum fase 3 studie in juli 2023. Therapeutic value Current treatment options PCSK9 remmers Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Er wordt geen duidelijke meerwaarde ten opzichte van PCSK9 remmers verwacht. Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration 300 mg (1,2 mL) References NCT04797104 (LIB003-004, LIBerate-FH) Additional remarks Expected patient volume per year Patient volume 72,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; Santos RD, Ruzza A, Hovingh GK, et al. Evolocumab in Pediatric Heterozygous Familial Hypercholesterolemia. N Engl J Med 2020; 383:1317-1327. Additional remarks De prevalentie van heterozygote FH is naar schatting één op de 250 personen in de algemene bevolking. Dit zou voor Nederland betekenen dat er mogelijk 72.000 patiënten in aanmerking zullen komen. 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 € 288,000,000.00 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