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 € 12,498,750.00 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 September 2026 Expected Registration June 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn 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 Er is niet veel te beoordelen uit de resultaten van de CELESTIMO studie (2) (Alleen abstract uit 2021. N=27, mprior lines 1 (1-4). Evalueerbaar n=17 pts, daarin 10/17, CMR 2/17 PMR). Er wordt meer verwacht van de concurrent epcoritamab/lenalidomide (CGT3013-02 studie) (3). Duration of treatment Frequency of administration Dosage per administration References EPAR Lunsumio (1); NCT04712097 (CELESTIMO) (2); Expertopinie (3). Additional remarks Doseringsschema met 1+2+60mg in cyclus 1, 60mg in cyclus 2 en 30mg in de daaropvolgende cycli (1). Expected patient volume per year Patient volume < 150 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Budget impact analyse van ibrutinib (Imbruvica) bij de behandeling van chronische lymfatische leukemie (1); Expertopinie (2). Additional remarks Er zijn 350 patiënten per jaar met FL of MZL die een tweedelijns behandeling starten (1). Het patiëntvolume in de recidief setting wordt niet hoger geschat dan 150 (2). 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 acht cycli Lunsumio €83.325 (exclusief BTW) (1). Potential total cost per year Total cost € 12,498,750.00 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