Selpercatinib Medicine 07 December 2022 Extended indication 2L+tumour agnostic–RET positive, no other satisfactory options Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Selpercatinib Domain Oncology Reason of inclusion Indication extension IND Main indication Tumour agnostic medication Extended indication 2L+tumour agnostic–RET positive, no other satisfactory options 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 Selpercatinib is een remmer van de rearranged during transfection (RET)-receptor tyrosinekinase. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2023 Expected Registration 2023 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Geen Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Median 13.2 month / months Frequency of administration 2 times a day Dosage per administration 160mg References SmPC; Meeting Abstract | 2022 ASCO Annual Meeting. Additional remarks ORR: 44% mPFS: 13,2 maanden Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References American Association for Cancer Research (AACR) Project GENIE cBioPortal for Cancer Genomics. AACR Project GENIE Consortium. AACR Project GENIE: powering precision medicine through an International Consortium. Cancer Discov. 2017;7(8):818-831. Additional remarks In LIBRETTO-001 waren de meest voorkomende tumoren anders dan long- of schildkliertumoren: pancreas, colorectaal, onbekend primair en cholangiocarcinoom. Dit komt grotendeels overeen met de voorspelde incidentiecijfers. Incidentie: Pancreas (0,08%), colorectaal (0,26%), onbekend primair (0,36%), cholangiocarcinoom (0,17%). het verwachte percentage van RET-incidenties in andere tumoren dan long en schildklier is 0,24%. 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 Z-index juli 2022 Additional remarks 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 Yes Indication extensions zie overige indicaties op de scan, ook lopende studies CNS kanker References AdisInsight Additional remarks Other information Additional remarks