Mosunetuzumab Medicine 03 December 2024 Extended indication Mosunetuzumab in combination with lenalidomide for second line or later treatment of relapsed/refractory CD20+ (grades 1-3a) follicular lymphoma in adults and elderly who have received at least one line of prior systemic therapy Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Mosunetuzumab Domain Hematology Reason of inclusion Indication extension IND Main indication Indolent non-Hodgkin’s lymphoma Extended indication Mosunetuzumab in combination with lenalidomide for second line or later treatment of relapsed/refractory CD20+ (grades 1-3a) follicular lymphoma in adults and elderly who have received at least one line of prior systemic therapy Current proprietary name Already available biosimilars / generics Proprietary name Lunsumio Manufacturer Roche Portfolio holder 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 November 2025 Expected Registration June 2026 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Indieningsdatum en verwachte registratie op basis van primary completion datum in augustus 2025. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References EPAR Lunsumio; NCT04712097 (CELESTIMO) Additional remarks Doseringsschema met 1+2+60 mg in cyclus 1, 60 mg in cyclus 2 en 30 mg in de daaropvolgende cycli. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 83,325.00 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 Medicijnkosten.nl Additional remarks Volgens het doseringsschema kosten 8 cycli Lunsumio €83.325 (excl. BTW) (1). 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