Lenalidomide Medicine 12 June 2018 Extended indication Extension of indication to include Revlimid in combination with rituximab (anti-CD20 antibody) for the treatment of adult patients with previously treated follicular lymphoma or marginal zone lymphoma. Therapeutic value No judgement yet Total cost € 867,100.00 Registration phase Registration application pending Product Active substance Lenalidomide Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Indolent non-Hodgkin’s lymphoma Extended indication Extension of indication to include Revlimid in combination with rituximab (anti-CD20 antibody) for the treatment of adult patients with previously treated follicular lymphoma or marginal zone lymphoma. 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. Scrip pipeline watch 29 dec 2017: RELEVANCE; not superior to chemotherapy regimen. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date March 2019 Expected Registration January 2020 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 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. De verwachting is 10 - 15 patiënten per jaar. Expected cost per patient per year Cost € 66,700.00 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 Potential total cost per year Total cost € 867,100.00 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 RVd en lenalidomide+rituximab+CHOP in ABC DLBCL References Fabrikant Additional remarks Other information Additional remarks