Ipilimumab Medicine 05 December 2023 Extended indication Extension of indication to include in combination with nivolumab the treatment of adult patients with unresectable stage III NSCLC Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Ipilimumab Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Extension of indication to include in combination with nivolumab the treatment of adult patients with unresectable stage III NSCLC Current proprietary name Already available biosimilars / generics Proprietary name Yervoy Manufacturer BMS Portfolio holder BMS Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks No EMA submission (https://news.bms.com/news/corporate-financial/2024/Bristol-Myers-Squibb-Provides-Update-on-Phase-3-CheckMate--73L-Trial/default.aspx) Therapeutic value Current treatment options Durvalumab Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zal mogelijk substitutie plaatsvinden met durvalumab. Er wordt verwacht dat bij oudere patiënten wel gepast gebruik zal plaatsvinden door de mogelijke toxiciteit van de ipi-nivo combinatie behandeling na radiotherapie. Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume < 2,231 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2021 (1); Expert opinie (2) Additional remarks In 2021 werden er 2.231 patiënten gediagnosticeerd met de indicatie stadium 3 NSCLC. Er wordt echter verwacht dat het volume lager zal uitvallen doordat niet alle oudere patiënten deze behandeling zullen krijgen (2). Expected cost per patient per year Cost References 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 Unknown Indication extensions References Additional remarks Other information Additional remarks