Extended indication Revlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult
Therapeutic value No judgement yet
Total cost 831,250.00
Registration phase Positive CHMP opinion


Active substance Lenalidomide
Domain Oncology and Hematology
Reason of inclusion Indication extension
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).
Proprietary name Revlimid
Manufacturer Celgene
Mechanism of action Immunosuppression
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional comments Immuunmodulator/T-cel activator. IMiD.


Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date March 2019
Expected Registration January 2020
Orphan drug Yes
Registration phase Positive CHMP opinion
Additional comments Positieve CHMP-opinie in november 2019.

Therapeutic value

Current treatment options RCVP, R Benda, rituximab, O Benda, idelalisib, ibrutinib
Therapeutic value No judgement yet
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 comments 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.

References Budget impact analyse van ibrutinib (Imbruvica) bij de behandeling van chronische lymfatische leukemie
Additional comments 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 66,500.00
References G-standaard; Fabrikant
Additional comments Dit zijn alleen de kosten voor lenalidomide

Potential total cost per year

Total cost


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.

Off label use

Off label use Yes
Indications off label use SLE, Behcet, sarcoidose, rNHL.
References G-standaard
Additional comments Lenalidomide heeft off-label add-ons.

Indication extension

Indication extension Yes
Indication extensions RVd
References Fabrikant

Other information

There is currently no futher information available.