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Lenalidomide / Rituximab

Revlimid / rituximab

Extended indication Relapsed/refractory follicular lymphoma (FL) en marginal zone lymphoma (MZL).
Therapeutic value No judgement
Total cost 900,000.00
Registration phase Clinical trials

Product

Active substance Lenalidomide / Rituximab
Domain Oncology and Hematology
Main indication Lymphoma
Extended indication Relapsed/refractory follicular lymphoma (FL) en marginal zone lymphoma (MZL).
Proprietary name Revlimid / rituximab
Manufacturer celgene
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks Immuunmodulator/T-cel activator. Scrip pipeline watch 29 dec 2017: RELEVANCE; not superior to chemotherapy regimen.

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Submission date 2019
Expected Registration January 2020
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Current treatment options Rituximab-CVP/Rituximab-CHOP
Therapeutic value No judgement
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.
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
References G-standaard; Fabrikant
Additional remarks €5.555 x 13 = € 72.000

Potential total cost per year

Total cost

900,000.00

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.

Off label use

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

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.