Etravirine Medicine 10 June 2020 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. Therapeutic value No judgement Total cost € 33,576.00 Registration phase Registered Product Active substance Etravirine Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Viral infections other 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. Current proprietary name Already available biosimilars / generics Proprietary name Intelence Manufacturer Janssen Portfolio holder Mechanism of action HIV inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Non-nucleoside reverse transcriptase inhibitor. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date November 2019 Expected Registration April 2020 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in maart 2020. Therapeutic value Current treatment options Tenofovir/ emtricitabine/ dolutegravir Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a day Dosage per administration Dose was decided according to dosing tables in protocol. References NCT01504841 Additional remarks Expected patient volume per year Patient volume 5 - 10 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References HIV Monitoring Report 2018, SHM 2018; CBS; GIP Additional remarks 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 € 4,197.00 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. References G- standaard en SmPC Additional remarks 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 € 33,576.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks