Glucagon Medicine 12 June 2018 Extended indication Treatment of severe hypoglycemia in people with diabetes treated with insulin. Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Glucagon Domain Metabolism and Endocrinology Reason of inclusion Main indication Hormonal disorders Extended indication Treatment of severe hypoglycemia in people with diabetes treated with insulin. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Eli Lilly Portfolio holder Mechanism of action Unknown Route of administration Nasal Therapeutical formulation Powder for topical use Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Peptidehormoon dat bloedsuikerspiegel verhoogt. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Nieuwe formulering van glucagon voor nasaal gebruik. Therapeutic value Current treatment options Glucagon injectie Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Deze nieuwe formulering is wezenlijk anders, alternatief voor injectie. Duration of treatment Frequency of administration Dosage per administration 3 mg References NCT02402933; clinical trials. gov.; Stenninger Diabetialogia 1993 Additional remarks Nu is er glucagon als injectie, nieuwe middel is andere formulering. Nog geen gepubliceerde data voorhanden. Van de 26 patiënten zijn 14 patiënten uit de studie gegaan. Expected patient volume per year Patient volume 4,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank; clinicaltrials.gov; Diabetes fonds Additional remarks Er waren in 2016 21.176 gebruikers van Glucagon (GlucaGen), nasaal glucagon zal hier een marktaandeel van moeten veroveren. Echter zijn eerste trails alleen uitgevoerd in 4-18 jarige populaties in type 1 diabetes. 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 Yes Indications off label use References clinicaltrials.gov. Additional remarks Nu alleen fase 3 in 4-18 jarige. Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks Op clinical trials. gov. is er een studie verricht waar van de 26 patiënten 14 patiënten uitvielen. Er is nog niks verder gepubliceerd over deze formulering.