Polihexanide Medicine 13 December 2018 Extended indication Acanthamoeba keratitis in patients aged 13 years and older. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Polihexanide Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Eye disorders Extended indication Acanthamoeba keratitis in patients aged 13 years and older. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer SIFI Portfolio holder Mechanism of action Disinfectant Route of administration Ocular Therapeutical formulation Eye drops Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Disinfectant that is active against bacteria and acanthamoeba. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options De behandeling bestaat uit oogdruppels met een ontsmettende werking, zoals chloorhexidine, brolene of PHMB. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Het wordt gebruikt als vervanging van chloorhexidine, maar het is nog onduidelijk wat de verwachte waarde is ten opzichte van chloorhexidine. Duration of treatment Frequency of administration Dosage per administration References NCT03274895 Additional remarks Clinical trial: 16 drops each in a day for 5 days,8 drops each in a day for 7 days,6 drops each in a day for 7 days and 4 drops each in a day up to clinical resolution. Expected patient volume per year Patient volume < 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References SPS, https://www.radboudumc.nl/patientenzorg/aandoeningen/acanthamoebe-keratitis/ Additional remarks SPS: "Acanthamoeba keratitis is a form of keratitis with a fairly low prevalence (7 cases per 1,000,000 in Europe)". Teruggerekend naar Nederland gaat dat om maximaal 119 personen. Op de website van het Radboud UMC is het volgende terug te vinden: in Nederland komt acanthamoebe-keratitis weinig voor, 30 tot 40 keer per jaar. Dit aantal lijkt toe te nemen. De inschatting is dat minder dan 100 patiënten per jaar die in aanmerking zullen komen voor dit geneesmiddel. 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 No Indication extensions References Additional remarks Other information Additional remarks