Semaglutide Medicine 04 June 2024 Extended indication Op dit moment heeft oraal semaglutide reeds een indicatie voor diabetes. De aan te vragen indicatieuitbreiding zal slaan op het behandelen van obesitas. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Semaglutide Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Other metabolism and Endocrinology Extended indication Op dit moment heeft oraal semaglutide reeds een indicatie voor diabetes. De aan te vragen indicatieuitbreiding zal slaan op het behandelen van obesitas. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Novo Nordisk Portfolio holder Novo Nordisk Mechanism of action Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date 2025 Expected Registration 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 25mg References NCT05035095 (OASIS 1); NCT05132088 (OASIS 2); NCT05890976 (OASIS 3); NCT05564117 (OASIS 4) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € < 1,200.00 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 Additional remarks De prijs van een tablet Rybelsus van 3, 7 of 14mg is gelijk en is €3,31 (inclusief BTW). Als een tablet van 25mg dit ook zal kosten zal een dagelijkse doorlopende behandeling €1.109,12 (exclusief BTW) per patiënt per jaar zijn (€3,31/1,09∗365,24). Potential total cost per year Total cost 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