Extended indication Multiple myeloom 1e lijn
Therapeutic value No judgement
Total cost 56,025,000.00
Registration phase Clinical trials

Product

Active substance Lenalidomide / bortezomib / dexamethason
Domain Oncology and Hematology
Main indication Multiple Myeloma
Extended indication Multiple myeloom 1e lijn
Proprietary name Revlimid / Velcade / dexamethason
Manufacturer celgene
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks Immuunmodulator/proteasoom inhibitor

Registration

Registration route Centralised (EMA)
Particularity Indication extension
Submission date May 2018
Expected Registration April 2019
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Therapeutic value No judgement
Frequency of administration 1 times a day
Dosage per administration 15 mg
References SWOG; Fabrikant
Additional remarks Revlimid op dag 1-21 van 28 dagen.

Expected patient volume per year

Patient volume

< 830

Market share is generally not included unless otherwise stated.

References NKR; Pakketadvies daratumumab (Darzalex®) bij multipel myeloom, ZIN 2017
Additional remarks Jaarlijks nieuwe MM patiënten bedraagt 1.117, waarvan 90% symptomatisch: 1.006. Patiënten <70 jaar zonder co-morbiditeiten bedraagt 50%. 95% wordt behandeld (478). Patiënten >70 jaar en >65 met co-morbiditeiten bedraagt 50%. 70% wordt behandeld (352). In totaal worden er dus jaarlijks 478+352=830 patiënten in de eerste lijn behandeld. Hoeveel patiënten hiervan daadwerkelijk met LBD zullen worden behandeld moet nog vastgesteld worden.

Expected cost per patient per year

Cost 67,000.00 - 68,000.00
References G-standaard; Fabrikant
Additional remarks €5.196 x 13 = € 67.548

Potential total cost per year

Total cost

56,025,000.00

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 en Velcade hebben off-label add-ons

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.