Selpercatinib Medicine 04 June 2026 Extended indication Selpercatinib monotherapy for adjuvant treatment of early stage (IB-IIIA) RET fusion-positive Non-small cell lung cancer in adults and elderly following definitive locoregional treatment with curative intent. Therapeutic value No estimate possible yet Total cost € 4,669,900.00 Registration phase Clinical trials Product Active substance Selpercatinib Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Selpercatinib monotherapy for adjuvant treatment of early stage (IB-IIIA) RET fusion-positive Non-small cell lung cancer in adults and elderly following definitive locoregional treatment with curative intent. Current proprietary name Already available biosimilars / generics Proprietary name Retsevmo Manufacturer Eli Lilly Portfolio holder Eli Lilly Mechanism of action Other Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Werkingsmechanisem: RET kinase inhibitor Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Indication extension ATMP Submission date June 2026 Expected Registration December 2026 Orphan drug Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Platina-gebaseerde chemotherapie. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In februari 2026 maakte Eli Lilly bekend dat uit de fase 3-studie LIBRETTO-432 bleek dat selpercatinib de event-free survival (EFS) significant verbeterde. Duration of treatment Frequency of administration Dosage per administration References LIBRETTO-432 trial (NCT04819100) Additional remarks Expected patient volume per year Patient volume < 41 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2023 (1); NVMO-commissie BOM. 2022 (2); Pakketadvies pralsetinib (Gavreto®) bij de behandeling van niet-kleincellige longkanker (3). Additional remarks In 2023 waren er 9.791 diagnoses NSCLC (1). Bij diagnose is er bij 4% van de patiënten sprake van stadium 1B, bij 2% stadium 2A, bij 6% stadium 2B en bij 9% stadium 3A ziekte (n=2.056) (2). Bij 1 tot 2% komt een RET-fusie voor (3). Expected cost per patient per year Cost € < 113,900.00 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 G-standaard juni 2026 Additional remarks Uitgaande van een geheel jaar een behandeling met 2x per dag 160mg =8765,18 komt dit neer op €113.947,34 per jaar. Potential total cost per year Total cost € 4,669,900.00 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