Amoxicilline / omeprazol / rifabutin Medicine 09 January 2018 Extended indication Eradicatie van Helicobacter pylori bij een ulcus pepticum. Therapeutic value No estimate possible yet Total cost € 11,000.00 Registration phase Clinical trials Product Active substance Amoxicilline / omeprazol / rifabutin Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Bacterial infections Extended indication Eradicatie van Helicobacter pylori bij een ulcus pepticum. Current proprietary name Already available biosimilars / generics Proprietary name Talicia Manufacturer RedHill Portfolio holder Mechanism of action Antibiotic Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Combinatie van twee antibiotica en een maagzuurremmer. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity New therapeutical formulation ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Betreft alternatief voor Panclamox. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Discussie zal zijn over rol van dit product als eerstelijns therapie. Goede respons percentages op huidige eerstelijns therapie. Duration of treatment Frequency of administration Dosage per administration References 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 Additional remarks Er wordt vooralsnog van uitgegaan dat dit middel in de tweede lijn zal worden ingezet. In dit geval zullen patiëntaantallen klein zijn; maximaal 100. 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, naar verwachting vergelijkbaar met Panclamox (uitgaande van 7-14 dagen, 2x per dag). Potential total cost per year Total cost € 11,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References SPS Additional remarks Other information Additional remarks