Lenalidomide / Rituximab Medicine 12 June 2018 Extended indication Relapsed/refractory follicular lymphoma (FL) en marginal zone lymphoma (MZL). Therapeutic value No judgement Total cost € 936,000.00 Registration phase Clinical trials Product Active substance Lenalidomide / Rituximab Domain Oncology and Hematology Reason of inclusion Main indication Lymphoma Extended indication Relapsed/refractory follicular lymphoma (FL) en marginal zone lymphoma (MZL). Current proprietary name Already available biosimilars / generics Proprietary name Revlimid / rituximab Manufacturer Celgene Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Immuunmodulator/T-cel activator. Scrip pipeline watch 29 dec 2017: RELEVANCE; not superior to chemotherapy regimen. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Indication extension ATMP Unknown Submission date 2019 Expected Registration January 2020 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Rituximab-CVP/Rituximab-CHOP Therapeutic value No judgement 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 Median 1 year / years Frequency of administration 1 times a day Dosage per administration 20 mg References Fabrikant; NCT01938001 Additional remarks Revlimid op dag 1-21 van 28 dagen voor maximaal 1 jaar. 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. Verwachting werkgroep: 10 - 15 patiënten per jaar. Expected cost per patient per year Cost € 72,000.00 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 G-standaard; Fabrikant Additional remarks €5.555 x 13 = € 72.000 Potential total cost per year Total cost € 936,000.00 Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References G-standaard Additional remarks Revlimid heeft off-label add-ons. Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks