Eltrombopag

Active substance
Eltrombopag
Domain
Cardiovascular diseases
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Other non-oncological hematological medications
Extended indication
Eltrombopag in combinatie met standaard immunosuppressieve therapie voor de behandeling van patiënten met ernstige aplastische anemie (SAA) als eerstelijnstherapie.

1. Product

Proprietary name
Revolade
Manufacturer
Novartis
Mechanism of action
Receptor agonist
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Extramural (GVS)
Additional comments
Thrombopoietin receptor agonist

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
May 2018
Expected Registration
August 2019
Orphan drug
No
Registration phase
Registration application pending

3. Therapeutic value

Current treatment options
Diverse waaronder stamceltransplantatie, bloedtransfusies, immuunsuppressiva
Therapeutic value
No judgement
Substantiation
Uit de klinische studie blijkt een 58% complete respons van Eltrombopag in combinatie met immuunsuppressiva versus 10% met immuunsuppressiva monotherapie.
Duration of treatment
Average 6 month / months
Frequency of administration
1 times a day
Dosage per administration
150 mg
References
Farmcotherapeutisch Kompas; Townsley et al. N Engl J Med 2017; 376:1540-1550
Additional comments
Voor behandeling zie Farmacotherapeutisch Kompas

4. Expected patient volume per year

Patient volume

10 - 34

Market share is generally not included unless otherwise stated.

References
Nederlandse Vereniging voor Hematologie; fabrikant; expertopinie
Additional comments
De incidentie bedraagt ongeveer 2:1.000.000. Dit betekend dus ongeveer 34 patiënten per jaar. De inschatting is 10-20 patiënten in 1e lijn (wat deels ten koste gaat van gebruik in 2e lijn).

5. Expected cost per patient per year

Cost
39,500
References
Fabrikant
Additional comments
Berekend op basis van huidige lijstprijs

6. Potential total cost per year

Total cost

869,000

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

Off label use
No

8. Indication extension

Indication extension
No

9. Other information

There is currently no futher information available.