Somatrogon Medicine 03 December 2024 Extended indication Somatrogon monotherapy for treatment of growth hormone deficiency in adults Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Somatrogon Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Metabolic diseases Extended indication Somatrogon monotherapy for treatment of growth hormone deficiency in adults Current proprietary name Already available biosimilars / generics Proprietary name Ngenla Manufacturer Pfizer Portfolio holder Pfizer Mechanism of action Hormonal therapy Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Dit geneesmiddel is in 2022 geregistreerd en vergoed voor kinderen en adolescenten vanaf 3 jaar. Dit betreft de indicatieuitbreiding naar volwassenen. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date June 2024 Expected Registration May 2025 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Verwachte registratie aan de hand van inschatting van de fabrikant. Therapeutic value Current treatment options Dagelijkse somatropine injecties, TransCon Growth Hormone, somapacitan 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 week Dosage per administration References NCT01909479 Additional remarks Behandelduur is persoonsafhankelijk. 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 € < 26,112.00 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 Kosten Ngenla 24 mg: €219,19 (incl. BTW), Ngenla 60 mg: €545,48 (incl. BTW) (1). Een wekelijkse behandeling met 60 mg kost €26.112,98 (excl. BTW) p.p.p.j. (€545,48/1,09∗52,18). 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 Unknown Indication extensions References Additional remarks Other information Additional remarks