Lenalidomide Medicine 12 June 2018 Extended indication Revlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a). Therapeutic value No judgement yet Total cost € 864,500.00 Registration phase Registered and reimbursed Product Active substance Lenalidomide Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Indolent non-Hodgkin’s lymphoma Extended indication Revlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a). Current proprietary name Already available biosimilars / generics Proprietary name Revlimid Manufacturer Celgene Portfolio holder Mechanism of action Immunosuppression Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Immuunmodulator/T-cel activator. IMiD. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date March 2019 Expected Registration December 2019 Orphan drug Yes Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in november 2019. Therapeutic value Current treatment options RCVP, R Benda, rituximab, O Benda, idelalisib, ibrutinib Therapeutic value No judgement yet This assessment does not indicate any potential inclusion in the package. Substantiation Lenalidomide / rituximab zal naar verwachting een plek krijgen bij folliculair lymfoom patiënten; in eerste instantie vooral voor chemorefractaire patiënten. Duration of treatment Average 48 week / weeks Frequency of administration 1 times a day Dosage per administration 20 mg References AUGMENT: NCT01938001 MAGNIFY: NCT01996865 Additional remarks Lenalidomide op dag 1-21 van 28 dagen voor maximaal 1 jaar. Vaste duur van behandeling. Expected patient volume per year Patient volume 10 - 15 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. Additional remarks Er zijn 350 patiënten per jaar met FL of MZL die een tweedelijns behandeling starten. Verwacht wordt dat het slechts zal worden ingezet bij een klein aantal patiënten, vanwege het grote aantal behandelopties. De verwachting is dat er 10 - 15 patiënten per jaar gebruik zullen maken van lenalidomide gezien de vele alternatieven. Expected cost per patient per year Cost € 66,500.00 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 G-standaard; Fabrikant Additional remarks Dit zijn alleen de kosten voor lenalidomide. Er is een financieel arrangement afgesloten per 1 juni 2020 tot en met 31 december 2021. Potential total cost per year Total cost € 864,500.00 Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References G-standaard Additional remarks Lenalidomide heeft off-label add-ons. Indication extension Indication extensions Yes Indication extensions Lenalidomide, Bortezomib, and Dexamethasone combinatie therapie References Fabrikant Additional remarks Other information Additional remarks