Selpercatinib Medicine 04 December 2025 Extended indication Extension of indication to include to include paediatric patients 2 years and older with: (1) Advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory, (2) Advanced RET-mutant medullary thyroid cancer, (3) Advanced RET fusion-positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted. Therapeutic value No estimate possible yet Total cost € 677,010.00 Registration phase Registration application pending Product Active substance Selpercatinib Domain Oncology Reason of inclusion Indication extension IND Main indication Thyroid cancer Extended indication Extension of indication to include to include paediatric patients 2 years and older with: (1) Advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory, (2) Advanced RET-mutant medullary thyroid cancer, (3) Advanced RET fusion-positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted. Current proprietary name Already available biosimilars / generics Proprietary name Retsevmo Manufacturer Eli Lilly Portfolio holder Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Tyrosine kinase inhibitor met antineoplastische eigenschappen. Potente, selectieve remmer van de RET-kinase, is ontwikkeld om de ATP-bindingsite van de RET-kinase te blokkeren. Zo wordt de ‘down stream’ signalling pathway geremd. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date July 2025 Expected Registration May 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Verwachte registratie op basis van tien maanden gemiddelde doorlooptijd bij een indicatieuitbreiding. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT03899792 (LIBRETTO-121, LOXO-RET-18036) Additional remarks Expected patient volume per year Patient volume < 10 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank Additional remarks In 2024 waren er minder dan 40 gebruikers voor RET-gemuteerde CNS tumoren. Met deze indicatieuitbreiding zullen er mogelijk minder dan tien patiënten per jaar bij komen. Expected cost per patient per year Cost € < 67,701.00 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 GIPdatabank Additional remarks In 2024 was de gemiddelde vergoeding per gebruiker van selpercatinib €67.701,09. Potential total cost per year Total cost € 677,010.00 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