Extended indication Immune thrombocytopenic purpura (first line)
Therapeutic value Possible equal value
Total cost 1,300,000.00
Registration phase Registration application pending

Product

Active substance Avatrombopag
Domain Cardiovascular diseases
Reason of inclusion New medicine (specialité)
Main indication Other non-oncological hematological medications
Extended indication Immune thrombocytopenic purpura (first line)
Manufacturer Dova
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional remarks Meer informatie over de werking van het product: "small-molecule thrombopoietin receptor (c-Mpl) agonist that stimulates platelet production."

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New medicine
Submission date June 2018
Expected Registration July 2019
Orphan drug No
Registration phase Registration application pending
Additional remarks Study 302: durable platelet responses.

Therapeutic value

Current treatment options Eltrombopag
Therapeutic value Possible equal value
Frequency of administration 1 times a day
Dosage per administration 5 mg - 40 mg
References NCT01438840

Expected patient volume per year

Patient volume

100

Market share is generally not included unless otherwise stated.

References GIP-databank, 2016
Additional remarks Het aantal personen in Nederland met ITP wordt geschat op ongeveer 5 op de 100.000 mensen (=850 personen). Aantal gebruikers Eltrombopag is 343, terwijl dit voor meer indicaties is geregistreerd dan ITP. Gezien de verwachte gelijke waarde is een realistisch patiëntaantal 100 personen.

Expected cost per patient per year

Cost 13,000.00
Additional remarks GIP databank geeft voor Eltrombopag in 2016, €13.139,00 p.p.p.j. aan.

Potential total cost per year

Total cost

1,300,000.00

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 Thrombocytopenia - associated with liver disease, pre-surgical procedure
References SPS

Other information

There is currently no futher information available.