Posaconazol Medicine 04 December 2025 Extended indication Extension of indication for NOXAFIL to include treatment of patients two years of age and older for invasive aspergillosis (IA) based on final results from study MK-5592-104. Therapeutic value Possible added value Total cost € 590,000.00 Registration phase Registered Product Active substance Posaconazol Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Fungal infections Extended indication Extension of indication for NOXAFIL to include treatment of patients two years of age and older for invasive aspergillosis (IA) based on final results from study MK-5592-104. Current proprietary name Already available biosimilars / generics Proprietary name Noxafil Manufacturer MSD Portfolio holder MSD Mechanism of action Antifungals Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Dit betreft een verandering in de registratie om de posologie van de drie toedieningsvormen (IV, PFS en tablet) voor de leeftijdsgroep 2 tot 18 jaar te harmoniseren. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date April 2025 Expected Registration March 2026 Orphan drug No Registration phase Registered Reimbursement Reimbursed from the basic package Medicine sluice Additional remarks Positieve CHMP-opinie in januari 2026, EC registratie in maart 2026. Therapeutic value Current treatment options Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Posaconazol werd goed verdragen en ging gepaard met hoge percentages klinische respons bij pediatrische patiënten met invasieve aspergillose. Duration of treatment Average 8 week / weeks Frequency of administration Dosage per administration Intraveneus: dag 1: oplaaddosis van 300 mg 2×/dag, daarna 300 mg 1×/dag. Schakel over op oraal gebruik ( tablet) zodra de conditie van de patiënt dit toelaat. Oraal: Tablet: dag 1: oplaaddosis van 300 mg 2×/dag, daarna 300 mg 1×/dag. Zo nodig kan gewisseld worden tussen orale ( tablet) en intraveneuze toediening. Behandelduur: 6–12 weken. References NCT04218851 (MK-5592-104); Kang et al. Antimicrob Agents Chemother. 2026; Expertopinie; Farmacotherapeutisch Kompas Additional remarks Expected patient volume per year Patient volume < 100 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Buil et al. Mycoses. 2020; Expertopinie Additional remarks Er zijn ongeveer 1.300 patiënten in Nederland met invasieve aspergillose, waarvan hooguit 100 kinderen. Expected cost per patient per year Cost € > 5,900.00 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 Medicijnkosten.nl; Farmacotherapeutisch Kompas Additional remarks In de kosteneffectiviteitsstudie werd een gemiddelde kostenbeslag per patiënt van €5.906,06 per 100 dagen gevonden. Noxafil, maagsapresistente tablet 100mg 0,3g per dag €64,53. Noxafil, suspensie voor oraal gebruik 40mg/ml 0,3g per dag €41,33. Potential total cost per year Total cost € 590,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks