Somapacitan Medicine 04 December 2025 Extended indication Sogroya is indicated for treatment of growth failure in children and adolescents in the following indications: - Growth disturbance (current height SDS < -2.5 and parental adjusted height SDS < -1) in short children born small for gestational age (SGA), with a birth weight and/or length below -2 SD, who failed to show catch-up growth (HV SDS < 0 during the last year) by 4 years of age or later, - Noonan syndrome (NS). Therapeutic value No estimate possible yet Total cost Registration phase Positive CHMP opinion Product Active substance Somapacitan Domain Metabolism and Endocrinology Reason of inclusion Indication extension IND Main indication Metabolic diseases Extended indication Sogroya is indicated for treatment of growth failure in children and adolescents in the following indications: - Growth disturbance (current height SDS < -2.5 and parental adjusted height SDS < -1) in short children born small for gestational age (SGA), with a birth weight and/or length below -2 SD, who failed to show catch-up growth (HV SDS < 0 during the last year) by 4 years of age or later, - Noonan syndrome (NS). Current proprietary name Already available biosimilars / generics Proprietary name Sogroya Manufacturer Novo Nordisk Portfolio holder Novo Nordisk Mechanism of action Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date December 2025 Expected Registration July 2026 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in mei 2026. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er is nog onvoldoende data bekend. In de studie wordt het effect en de veiligheid van eenmaal per week toegediende somapacitan vergeleken met dagelijkse Norditropin®. Als hier een gelijke waarde uit blijkt dan is met name het toegenomen gebruiksgemak een voordeel. Duration of treatment Frequency of administration 1 times a day Dosage per administration References NCT05330325 (REAL 8); NCT05723835 (REAL 9) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Tijtgat et al., J Pediatr Endocrinol Metab, 2022. Additional remarks Jaarlijks worden circa 2.500 kinderen in Nederland verwezen voor evaluatie van korte lengte. Het zal waarschijnlijk gaan om een kleine subset van kinderen met een forse groeiachterstand (SD -2,5) die zich nog niet in de puberteit bevinden. Expected cost per patient per year Cost € 17,000.00 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 Farmacotherapeutisch Kompas Additional remarks Sogroya heeft een prijs van € 170,00 voor 1,5 ml injectievloeistof (3,333 mg/ml). Volgens een IHSI-inschatting op basis van prijzen uit Denemarken worden de gemiddelde kosten per patiënt per jaar geschat op €17.000. 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