Olokizumab

Active substance
Olokizumab
Domain
Chronic immune diseases
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Rheumatism
Extended indication
Moderate-to-severe rheumatoid arthritis in adults who previously failed DMARD therapy in combination with methotrexate.

1. Product

Manufacturer
R-Pharm
Mechanism of action
Interleukin inhibitor
Route of administration
Subcutaneous
Therapeutical formulation
Injection
Budgetting framework
Intermural (MSZ)
Additional comments
Monoklonaal antilichaam gericht tegen IL-6. Bekostigingskader mogelijk intramuraal conform sarilumab

2. Registration

Registration route
Centralised (EMA)
Submission date
2020
Expected Registration
2021
Orphan drug
No
Registration phase
Clinical trials
Additional comments
Meerdere fase 3 studies lopen af in de loop van 2019

3. Therapeutic value

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

4. Expected patient volume per year

Patient volume

100 - 300

Market share is generally not included unless otherwise stated.

Additional comments
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.

5. Expected cost per patient per year

Cost
10,000
References
GIPdatabank
Additional comments
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.

6. Potential total cost per year

Total cost

2,000,000

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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

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

9. Other information

There is currently no futher information available.