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Doravirine / ​lamivudine / ​tenofovirdisoproxil

Delstrigo

Extended indication Delstrigo is also indicated for the treatment of adolescents aged 12 years and older weighing at lea
Therapeutic value No estimate possible yet
Total cost 654,000.00
Registration phase Registered and reimbursed

Product

Active substance Doravirine / ​lamivudine / ​tenofovirdisoproxil
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication HIV
Extended indication Delstrigo is also indicated for the treatment of adolescents aged 12 years and older weighing at least 35kg who are infected with HIV-1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil.
Proprietary name Delstrigo
Manufacturer MSD
Mechanism of action HIV inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Extramural (GVS)
Additional remarks Doravirine (non-nucleoside reverse transcriptase inhibitor), lamivudine (nucleoside reverse transcriptase inhibitor) en tenofovir disoproxil fumarate (nucleotide reverse transcriptase inhibitor).

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date August 2021
Expected Registration June 2022
Orphan drug No
Registration phase Registered and reimbursed
Additional remarks Positieve CHMP opinie ontvangen februari 2022

Therapeutic value

Current treatment options Een combinatie van twee of drie antivirale middelen (cART) uit verschillende groepen met verschillende werkingsmechanismen en niet-overlappende resistentieprofielen.
Therapeutic value No estimate possible yet

Expected patient volume per year

Patient volume

< 109

Market share is generally not included unless otherwise stated.
References Monitoring Report 2017 (HIV Monitoring, pagina 41), SHM (1); Expert opinie (2);
Additional remarks In 2016 waren in Nederland 19.035 mensen met HIV in zorg. 97% hiervan (18.552) was ooit gestart met de antiretrovirale combinatietherapie (cART). Per jaar worden ongeveer 1.000 nieuwe HIV-patiënten verwacht (1). Naast het vaste combinatiepreparaat doravirine/lamivudine/tenofovirdisoproxil is doravirine ook beschikbaar als mono preparaat (bevat doravirine als enige werkzame stof). Populatie die in aanmerking komt zijn diegenen die vroeger gefaald hebben op nefirapine, of patiënten die behandeld worden met nefirapine (met sprake van veel interacties) omzetten naar dit middel met minder interacties. Het is de verwachting dat er voor de volwassenen indicatie 200 patiënten in aanmerking zullen komen en 10 patiënten voor de pediatrische indicatie(2).

Expected cost per patient per year

Cost > 6,000.00
References medicijnkosten
Additional remarks Doravirine / lamivudine / tenofovir disoproxil tablet100/300/245mg kost €17,68, uitgaande van 1 tablet per dag voor een jaar zou dat neerkomen op €6.453,13 per patiënt per jaar (inclusief BTW). Exclusief BTW komt dit neer op ongeveer €6.000.

Potential total cost per year

Total cost

654,000.00

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.