Tiragolumab Medicine 04 June 2024 Extended indication In combination with atezolizumab for first line treatment of locally advanced, unresectable stage III Non-small cell lung cancer in adults and elderly who have no progression during or following concurrent platinum-based chemoradiotherapy. Therapeutic value No estimate possible yet Total cost € 65,000,000.00 Registration phase Clinical trials Product Active substance Tiragolumab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication In combination with atezolizumab for first line treatment of locally advanced, unresectable stage III Non-small cell lung cancer in adults and elderly who have no progression during or following concurrent platinum-based chemoradiotherapy. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Roche Portfolio holder Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date July 2025 Expected Registration November 2026 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indieningsdatum en verwachte registratie op basis van informatie fabrikant. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Nog geen resultaten bekend. Duration of treatment Frequency of administration 1 times every 4 weeks Dosage per administration 840 mg References NCT04513925 (SKYSCRAPER-03) Additional remarks Expected patient volume per year Patient volume < 1,300 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR2021 (1); Expertopinie (2); Declaratiedata. 2023 (3). Additional remarks In 2021 waren er 10.096 diagnoses NSCLC in Nederland. Dit betrof 1.727 patiënten in stadium I, 822 patiënten in stadium II, 2.231 patiënten in stadium III, 5.247 patiënten in stadium IV (1). Deze combinatie zal waarschijnlijk ingezet worden als subsitutie van durvalumab na chemo/radiotherapie (<1.300 gebruikers) (2,3). Expected cost per patient per year Cost € 40,000.00 - 60,000.00 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 Additional remarks Er is nog niks bekend over de prijs. Het is waarschijnlijk dat de prijs in lijn is met andere PD-1/PD-L1 remmers. Potential total cost per year Total cost € 65,000,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks