Vonoprazan Medicine 04 June 2024 Extended indication Patients with Helicobacter pylori infection. Therapeutic value Possible added value Total cost € 1,485,000.00 Registration phase No registration expected Product Active substance Vonoprazan Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Bacterial infections Extended indication Patients with Helicobacter pylori infection. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Takeda Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Fabrikant geeft aan dat deze ontwikkeling niet in Europa wordt verwacht. Therapeutic value Current treatment options Panclamox, lansoprazol Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Dit betreft een maagzuurremmer, gecombineerd met antibiotica. Naar verwachting zal de potentie groter zijn dan andere protonpomp remmers. Het bijwerkingenprofiel is naar verwachting gunstiger (30% bijwerkingen versus 40% bijwerkingen bij lansoprazo). Duration of treatment Average 14 day / days Frequency of administration 3 times a day Dosage per administration 20 mg References NCT04167670 Additional remarks Deelnemers krijgen 14 dagen lang tweemaal daags 20 miligram vonoprazan in combinatie met 1gram amoxicilline driemaal daags. Expected patient volume per year Patient volume < 13,500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIP databank Additional remarks In 2022 waren er 13.298 gebruikers van Panclamox. De verwachting is dat vonoprazan een deel van de markt zal overnemen. Expected cost per patient per year Cost € 70.00 - 150.00 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 Additional remarks Beperkte kosten, mogelijk vergelijkbaar met Panclamox (uitgaande van 7 tot 14 dagen, 2 maal per dag). Potential total cost per year Total cost € 1,485,000.00 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