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Olokizumab

Extended indication Moderate-to-severe rheumatoid arthritis in adults who previously failed DMARD therapy in combination
Therapeutic value Possible equal value
Total cost 2,000,000.00
Registration phase Clinical trials

Product

Active substance Olokizumab
Domain Chronic immune diseases
Reason of inclusion New medicine (specialité)
Main indication Rheumatism
Extended indication Moderate-to-severe rheumatoid arthritis in adults who previously failed DMARD therapy in combination with methotrexate.
Manufacturer R-Pharm
Mechanism of action Interleukin inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Monoklonaal antilichaam gericht tegen IL-6. Bekostigingskader mogelijk intramuraal conform sarilumab

Registration

Registration route Centralised (EMA)
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials
Additional remarks Meerdere fase 3 studies lopen af in de loop van 2019

Therapeutic value

Current treatment options Andere IL-6 inhibitors: tocilizumab en sarilumab
Therapeutic value Possible equal value
Substantiation De inschatting is dat olokizumab competitief is met tocilizumab en sarilumab.
Duration of treatment continuous
Frequency of administration 1 times every 4 weeks
Dosage per administration 64 mg
References NCT02760433; NCT02760368; NCT02760407

Expected patient volume per year

Patient volume

100 - 300

Market share is generally not included unless otherwise stated.
Additional remarks Afhankelijk van de uiteindelijke indicatiestelling, therapeutische meerwaarde en de plaats in de behandelrichtlijn mogelijk enkele honderden patiënten. Zal de concurrentie moeten aangaan met andere IL-6 remmers. Inschatting: 100-300 patiënten.

Expected cost per patient per year

Cost 10,000.00
References GIPdatabank
Additional remarks Afhankelijk van de therapeutische meerwaarde maar naar verwachting vergelijkbaar met andere biological IL-6 remmers zoals tocilizumab. De vergoeding voor tocilizumab bedroeg van 2012-2015 rond de €10.000 per patiënt per jaar.

Potential total cost per year

Total cost

2,000,000.00

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

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Ziekte van Crohn (fase 2)
References clinicaltrials.gov

Other information

There is currently no futher information available.