Tedopi Medicine 08 June 2021 Extended indication 2nd or 3rd Line in HLA-A2 Positive Patients With Advanced NSCLC After Failure of Immune Checkpoint Inhibitor. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Tedopi Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication 2nd or 3rd Line in HLA-A2 Positive Patients With Advanced NSCLC After Failure of Immune Checkpoint Inhibitor. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer OSE Pharma Portfolio holder Mechanism of action Other, see general comments Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Cytotoxic T lymphocyte stimulants Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indieningsdatum gebaseerd op primary completion datum in december 2021. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Op dit moment zijn er resultaten van een follow up van 12 maanden bij 100 patiënten. De effectiviteit zal nog verder aangetoond moeten worden. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 1 mL References NCT02654587 (ATALANTE 1) Additional remarks OSE2101 will be administered as a 1 mL-subcutaneous injection on Day 1 every three weeks for six cycles, then every eight weeks for the remainder of year one and finally every twelve weeks beyond year one until unequivocal RECIST 1.1-defined disease progression as determined by the investigator, unacceptable toxicity, or consent withdrawal. Expected patient volume per year Patient volume 500 - 1,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2018; Richtlijn niet-kleincellig longcarcinoom, NVALT 2020; Expertopinie; Pakketadvies sluisgeneesmiddel atezolizumab (Tecentriq®) bij gemetastaseerde niet-kleincellige longkanker, ZIN 2018; Mezquita et al. Lung Cancer. 2017 Oct;112:10-15. Additional remarks In 2018 waren er 10.190 diagnoses NSCLC in Nederland, hiervan heeft 10% stadium IIIb (1.090), 50% stadium VI (5.095). Hier komen nog patiënten bij uit eerdere stadia die verslechteren naar stadium IIIb/IV. Binnen een jaar is de inschatting dat dit 20% van stadium I/II bedraagt (529) en 50% van stadium IIIa (713). In totaal bedraagt deze groep dus 7.427 patiënten. In 2018 kregen 4.825 patiënten met NSCLC systemische therapie (65%). Ongeveer 45% van de patiënten met een systemische behandeling in de eerste lijn zal in aanmerking komen voor een tweedelijnsbehandeling (2.173). Ongeveer 48% van de tumoren is HLA-A2 positief (1.043). Er wordt verwacht dat er uiteindelijk 500-1.000 patiënten in aanmerking kunnen komen voor deze behandeling. 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 Yes Indication extensions Adis insight References Breast cancer; Colorectal cancer; Ovarian cancer; Pancreatic cancer; Prostate cancer Additional remarks Other information Additional remarks