Insulin oral Medicine 05 December 2023 Extended indication Diabetes Type 2 Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Insulin oral Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Diabetes Extended indication Diabetes Type 2 Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Oramed Portfolio holder Oramed Mechanism of action Route of administration Oral Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date July 2026 Expected Registration August 2027 Orphan drug Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options insuline 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 18mg References NCT04754334; Eldor R, Neutel J, Homer K, Kidron M. Efficacy and safety of 28-day treatment with oral insulin (ORMD-0801) in patients with type 2 diabetes: A randomized, placebo-controlled trial. Diabetes Obes Metab. 2021 Nov;23(11):2529-2538. doi: 10.1111/dom.14499. Epub 2021 Aug 18. PMID: 34310011. Additional remarks Expected patient volume per year Patient volume < 1,000,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References https://www.diabetesfonds.nl/over-diabetes/diabetes-in-het-algemeen/diabetes-in-cijfers Additional remarks 1,2 miljoen Nederlanders hebben diabetes, dus 1 op de 14 Nederlanders. Iets meer mannen dan vrouwen. Naar schatting zijn er meer dan 1,1 miljoen Nederlanders met prediabetes, een voorfase van diabetes type 2. Daarnaast zijn er ook mensen die diabetes hebben, maar dit nog niet weten. Het is niet bekend hoe groot deze groep is. 52.000 Nederlanders per jaar horen dat ze diabetes hebben. Dat zijn 1.000 mensen per week, 150 per dag. 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks