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.

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.

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.

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

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.

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.

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.

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.