Pitavastatine Medicine 04 June 2024 Extended indication Reduce the risk of cardiovascular disease in HIV-infected adults. Therapeutic value No estimate possible yet Total cost € 12,285,000.00 Registration phase Clinical trials Product Active substance Pitavastatine Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication HIV Extended indication Reduce the risk of cardiovascular disease in HIV-infected adults. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Kowa Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Werkingsmechanisme: HMG-CoA-reductaseremmers. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2025 Expected Registration 2026 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks NCT02344290 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 2 mg References Drugs.com Additional remarks De werkgroep schat in dat pitavastatine waarschijnlijk niet geadviseerd gaat worden. Expected patient volume per year Patient volume 3,000 - 12,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks In verschillende landen staat het inzetten van een statine al in de richtlijnen. De verwachting is dat een andere effectieve statine ingezet gaat worden. Expected cost per patient per year Cost € < 1,638.00 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 Drugs.com Additional remarks De kosten in de Verenigde Staten voor pitavastatine orale tablet 1, 2 of 4 mg bedraagt ongeveer $461,50 (~€404) voor 90 tabletten. De prijs in de Verenigde Staten ligt doorgaans hoger dan in Nederland. Een jaarvoorraad kost dan ongeveer €1.638. Potential total cost per year Total cost € 12,285,000.00 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