Etravirine

Active substance
Etravirine
Domain
Infectious diseases
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Viral infections
Extended indication
INTELENCE, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in antiretroviral treatment experienced adult patients and in antiretroviral treatment experienced paediatric patients from 2 years of age.

1. Product

Proprietary name
Intelence
Manufacturer
Janssen
Mechanism of action
HIV inhibitor
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Extramural (GVS)
Additional comments
Non-nucleoside reverse transcriptase inhibitor.

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
November 2019
Expected Registration
May 2020
Orphan drug
No
Registration phase
Positive CHMP opinion
Additional comments
Positieve CHMP-opinie in maart 2020.

3. Therapeutic value

Current treatment options
Tenofovir/ emtricitabine/ dolutegravir
Therapeutic value
No judgement
Duration of treatment
Not found
Frequency of administration
2 times a day
Dosage per administration
Dose was decided according to dosing tables in protocol.
References
NCT01504841

4. Expected patient volume per year

Patient volume

5 - 10

Market share is generally not included unless otherwise stated.

References
HIV Monitoring Report 2018, SHM 2018; CBS; GIP
Additional comments
In 2018 waren er volgens het HIV monitoring rapport 183 patiënten in zorg die onder de 18 jaar waren. Daarnaast waren er volgens het GIP 167 patiënten boven de 6 jaar. Naar verwachting zal het aantal patiënten van 2 tot 6 jaar dus beperkt zijn.

5. Expected cost per patient per year

Cost
4,197
References
G- standaard en SmPC
Additional comments
Voor kinderen wordt een prijs verwacht van tussen de €2.098- €3.168. Volwassenen: 200 mg 2× per dag. Kinderen vanaf 6 jaar en een lichaamsgewicht ≥ 16 kg: Lichaamsgewicht 16–20 kg: 100 mg 2× per dag, 20–25 kg: 125 mg 2× per dag, 25–30 kg: 150 mg 2× per dag, ≥ 30 kg: 200 mg 2× per dag.

6. Potential total cost per year

Total cost

31,478

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

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.