Pravastatine / fenofibraat Medicine 04 June 2024 Extended indication Extension of indication to include treatment of mixed hyperlipidaemia in adult patients while on a treatment with pravastatin 40mg monotherapy or on another moderate-intensity statin regimen Therapeutic value Possibly no place in the treatment regimen Total cost Registration phase Registered Product Active substance Pravastatine / fenofibraat Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Lipid-lowering medications Extended indication Extension of indication to include treatment of mixed hyperlipidaemia in adult patients while on a treatment with pravastatin 40mg monotherapy or on another moderate-intensity statin regimen Current proprietary name Already available biosimilars / generics Proprietary name Pravafenix Manufacturer Sage Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Galephar Netherlands Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date December 2023 Expected Registration November 2024 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie september 2024. Therapeutic value Current treatment options Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation Er wordt geen therapeutische meerwaarde verwacht in Nederland voor een combinatiepreparaat met fenofibraat. Fibraten hebben alleen een indicatie ter preventie van pancreatitis bij ernstige hypertriglyceridemie of gecombineerde hyperlipidemie. Fenofibraat kan indien nodig ook los met andere statines worden gecombineerd. Echter worden fibraten niet veel voorgeschreven in Nederland (2). Duration of treatment Frequency of administration Dosage per administration References NCT03214211 (1); Expertopinie (2). Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Familiaire gecombineerde hyperlipidemie. Erfocentrum. 2023 (1); GIPdatabank. 2024 (2); Expertopinie (3). Additional remarks Familiaire gecombineerde hyperlipidemie komt voor bij ongeveer 1 op 300 Nederlanders (1). In 2023 waren er 95.672 gebruikers van pravastatin (2). Er wordt echter geen meerwaarde verwacht van dit combinatiepreparaat dus er worden weinig gebruikers verwacht (3). 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 Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks