Alirocumab Medicine 06 June 2023 Extended indication Extension of indication to include treatment of paediatric patients 8 years of age and older with heterozygous familial hypercholesterolemia (HeFH) as an adjunct to diet, alone or in combination with other LDL -C lowering therapies. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Alirocumab Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Lipid-lowering medications Extended indication Extension of indication to include treatment of paediatric patients 8 years of age and older with heterozygous familial hypercholesterolemia (HeFH) as an adjunct to diet, alone or in combination with other LDL -C lowering therapies. Current proprietary name Already available biosimilars / generics Proprietary name Praluent Manufacturer Sanofi Portfolio holder Sanofi Mechanism of action Enzyme inhibitor 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 Unknown ATMP No Submission date March 2023 Expected Registration January 2024 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 Dosage per administration References 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 Voor alirocumab is een financieel arrangement van toepassing tot 1 januari 2027. Gemiddelde prijs per 1 wegwerpspuit Praluent, 1 ml injectievloeistof 150 mg/ml € 225,66 incl. btw. 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