Dasiglucagon Medicine 13 December 2018 Extended indication Treatment of Hypoglycemia in patients with Type 1 Diabetes Therapeutic value Possible equal value Total cost Registration phase Clinical trials Product Active substance Dasiglucagon Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Diabetes Extended indication Treatment of Hypoglycemia in patients with Type 1 Diabetes Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Zealand Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Stable analogue of glucagon in ready to use pen. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks NCT03378635 Therapeutic value Current treatment options GlucaGen Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Vergelijkbaar effect op herstel van ernstige hypoglycemie in vergelijking met huidig gebruikte glucagon Duration of treatment Frequency of administration Dosage per administration References NCT03378635; expertopinie Additional remarks Single fixed dose Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank Additional remarks Totaal aantal glucagon gebruikers in 2016 bedroeg 21.176 (GIP-databank). Een deel van deze personen zal mogelijk overstappen naar dasiglucagon. Het totaal aantal glucagongebruikers zal waarschijnlijk niet veranderen door de introductie van dasiglucagon Expected cost per patient per year Cost € 40.00 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, GIP-databank Additional remarks Glucagon poeder voor injectievloeistof 1 mg kost in juni 2018 € 29,80 (medicijnkosten.nl). Totale kosten per gebruiker in 2017 bedroegen € 39,50 (GIP-databank). De kosten van dasiglucagon zullen naar verwachting in dezelfde range zijn. Potential total cost per year Total cost 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 clinicaltrails.gov Additional remarks geen fase III studies voor andere indicaties. Other information Additional remarks