Extended indication Extension of indication to include treatment of adult patients with primary immune thrombocytopeni
Therapeutic value No estimate possible yet
Total cost 5,236,000.00
Registration phase Registration application pending

Product

Active substance Eltrombopag
Domain Hematology
Reason of inclusion Indication extension
Main indication Other hematology
Extended indication Extension of indication to include treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) irrespective of time since initial diagnosis
Proprietary name Revolade
Manufacturer Novartis
Mechanism of action Receptor antagonist
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Submission date January 2022
Expected Registration November 2022
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Therapeutic value No estimate possible yet
Frequency of administration 1 times a day
References NCT03524612 (TAPER)
Additional comments Participants will be treated with eltrombopag to induce sustained remission to reach a target platelet count of ≥ 100×109/L (CR), after 1st line steroids have failed. eltrombopag is for oral use and comes in 12.5, 25, 50 and 75 mg tablets; prescribed dose is taken once daily.

Expected patient volume per year

Patient volume

< 680

Market share is generally not included unless otherwise stated.

References erfelijkheid.nl
Additional comments ITP komt bij ongeveer 1 tot 4 op de 100.000 mensen voor.

Expected cost per patient per year

Cost 1,400.00 - 14,000.00
References GIPdatabank
Additional comments In 2021 werd er per gebruiker €14.025 vergoed.

Potential total cost per year

Total cost

5,236,000.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.