Selpercatinib Medicine 07 June 2022 Extended indication 1L treatment advanced or metastatic RET fusion-positive thyroid cancer (TC) Therapeutic value No estimate possible yet Total cost € 2,584,200.00 Registration phase Clinical trials Product Active substance Selpercatinib Domain Oncology Reason of inclusion Indication extension IND Main indication Thyroid cancer Extended indication 1L treatment advanced or metastatic RET fusion-positive thyroid cancer (TC) Current proprietary name Already available biosimilars / generics Proprietary name Retsevmo Manufacturer Eli Lilly Portfolio holder Eli Lilly 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, 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 2023 Expected Registration 2024 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options 1L: radioactief jodium, chirurgie; 2L: sorafenib/ selpercatinib Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De LIBRETTO 3 eerstelijnsstudie MTC loopt in Nederland. Duration of treatment Frequency of administration 2 times a day Dosage per administration 160mg References Samenvatting van de Productkenmerken (SmPC) Retsevmo Additional remarks Expected patient volume per year Patient volume < 20 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL 2018 (1); Additional remarks Er zijn maximaal 100 patiënten met schildkliercarcinoom (exclusief medullair). Mogelijk zo'n 10%-20% van deze groep zal "RET fusion positive" schildkliercarcinoom hebben (1). Bij de niet-medullaire schildkliercarcinoom wordt niet wordt getest en gezien er daarvoor standaardbehandelingen is de inschatting dat er toch minder patiënten in aanmerking komen. Niet uit te sluiten is echter dat bij de niet-medullaire schildklierkankers er in de toekomst meer getest gaat worden omdat selpercatinib weinig toxiciteit lijkt te hebben en goede uitkomsten laat zien. Mogelijk zou dat op termijn nog wel een toename in patiënten kunnen veroorzaken. Expected cost per patient per year Cost € 129,210.00 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 november 2022 Additional remarks Potential total cost per year Total cost € 2,584,200.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions NSCLC References Adis Insight Additional remarks Other information Additional remarks