Treprostinil

Active substance
Treprostinil
Domain
Cardiovascular diseases
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Other medication for cardiovascular diseases
Extended indication
Treatment of adults with chronic thromboembolic pulmonary hypertension (CTEPH) who cannot have surgery, and in patients whose CTEPH continues or has come back after surgery.

1. Product

Proprietary name
Treprostinil SciPharm Sàrl
Manufacturer
onbekend
Mechanism of action
Vasodilator
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Extramural (GVS)
Additional comments
Treprostinil diethanolamide is een vasodilator, synthetische analoog van prostacycline.

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Particularity
New therapeutical formulation
Submission date
March 2019
Expected Registration
April 2020
Orphan drug
Yes
Registration phase
Registration application pending
Additional comments
De fabrikant heeft een eerdere registratieaanvraag in september 2018 teruggetrokken omdat het niet kon voldoen aan de vraag van de EMA om additionele data aan te leveren.

3. Therapeutic value

Current treatment options
Treprostinil IV (Remodulin)
Therapeutic value
No judgement
Duration of treatment
Not found
References
United Therapeutics
Additional comments
De FREEDOM-EV trial heeft de primaire eindpunten gehaald.

4. Expected patient volume per year

Patient volume

< 28

Market share is generally not included unless otherwise stated.

References
GIPdatabank
Additional comments
In 2016 waren er 28 gebruikers van Remodulin.

5. Expected cost per patient per year

Cost
150,000
References
GIPdatabank
Additional comments
In 2016 werd er €150.720 vergoed per gebruiker.

6. Potential total cost per year

Total cost

4,200,000

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
Systemic sclerosis
References
EMA; Clinicaltrials.gov
Additional comments
Orphan designation voor deze indicatie, momenteel bevinden studies zich in fase II.

9. Other information

There is currently no futher information available.