Lurbinectedin Medicine 12 June 2018 Extended indication Small cell lung cancer (SCLC). Therapeutic value No estimate possible yet Total cost € 223,600,000.00 Registration phase No registration expected Product Active substance Lurbinectedin Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Small cell lung cancer (SCLC). Current proprietary name Already available biosimilars / generics Proprietary name Zepsyre Manufacturer Pharma Mar Portfolio holder Mechanism of action Alkylating agent Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Alkylating agent; binds to DNA minor groove and inhibits RNA polymerase II. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date 2025 Expected Registration 2026 Orphan drug Yes Registration phase No registration expected Reimbursement Medicine sluice Additional remarks De ATLANTIS trial liet geen statistisch significante overall survival zien. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de tweede lijn in combinatie met doxorubicine werd er geen overall survival verbetering gevonden ten opzichte van topotecan. Er is wel sprake van minder toxiciteit. Duration of treatment Frequency of administration Dosage per administration References NCT02566993 (ATLANTIS); Lancet Respir Med. 2023 Jan;11(1):74-86. Additional remarks Expected patient volume per year Patient volume < 1,118 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks In 2016 werden er 1.118 diagnoses stadium 4 SCLC geregistreerd. Expected cost per patient per year Cost € < 200,000.00 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 Drugs.com Additional remarks In de Verenigde Staten kosten 30 tabletten van 100mg ongeveer $18,500 (€16.400). De behandelduur is momenteel onbekend maar bij behandeling van een jaar zouden de kosten neerkomen op ongeveer €200.000. Mogelijk zal de prijs in de Europa lager uitvallen dan in de Verenigde Staten. Financieel grote impact gezien het bovenop de kosten komt voor doxorubicin. Potential total cost per year Total cost € 223,600,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Clinicaltrials.gov Additional remarks Onderzocht in fase 3 voor eierstokkanker, maar eindpunten niet gehaald. Other information Additional remarks