Fexapotide Medicine 08 December 2020 Extended indication Treatment of Benign Prostatic Hyperplasia Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Fexapotide Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Metabolic diseases Extended indication Treatment of Benign Prostatic Hyperplasia Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Nymox Portfolio holder Mechanism of action Other, see general comments Route of administration Intralesional Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Apoptosis stimulant. Toediening door middel van een injectie in de prostaat. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2023 Expected Registration 2024 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options 5-alpha-reductaseremmers, naast medicamenteuze behandeling is er de operatieve behandeling, TURP (transurethrale resectie prostaat). 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 2.5 mg References NCT01846793; NCT00945490; N. Shore. Efficacy and safety of fexapotide triflutate in outpatient medical treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia. 2019. Additional remarks 2,5mg NX-1207 in 10mL saline vehicle. Two Doses 1-8 Years Apart. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks BPH komt voornamelijk voor bij mannen van middelbare en meer gevorderde leeftijd. Tussen de 60-69 jaar heeft zo'n 10%-20% er last van en in de leeftijd van 70-79 jaar stijgt dit naar zo'n 25%-35%. Boven de 80 heeft ongeveer de helft van de mannen BPH. In de leeftijdsgroep van 60 tot 70 waren er 1.049.662 *15% mannen. In de leeftijdsgroep van 70 tot 80: 757.590 * 30%. Boven de 80 zijn er: 326.545*50%. Dit betekent dat er in Nederland rond de 550.000 mannen zijn die in enige mate hyperplasie van de prostaat hebben. Een gedeelte van deze personen zal mogelijk in aanmerking komen voor fexapotide. 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