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Doravirine / lamivudine / tenofovir disoproxil (fumarate)

Extended indication HIV infection
Therapeutic value No judgement
Total cost 2,160,000.00
Registration phase Registration application pending

Product

Active substance Doravirine / lamivudine / tenofovir disoproxil (fumarate)
Domain Infectious diseases
Main indication Viral infections other
Extended indication HIV infection
Manufacturer MSD
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
Particularity New medicine
Submission date December 2017
Expected Registration November 2018
Orphan drug No
Registration phase Registration application pending

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 judgement
Substantiation Gezien de combinatie met TDF (tenofovir disoproxil fumarate) en lamivudine verwacht de werkgroep meer bijwerkingen in vergelijking tot de huidige behandelopties.
Duration of treatment continuous
Frequency of administration 1 times a day
Dosage per administration 100/300/300 mg
References clinicaltrials.gov, NCT02397096

Expected patient volume per year

Patient volume

< 200

Market share is generally not included unless otherwise stated.
References Monitoring Report 2017 (HIV Monitoring, pagina 41), SHM.
Additional remarks In 2016 waren in Nederland 19035 mensen met hiv in zorg. 97% hiervan (18552) was ooit gestart met de antiretrovirale combinatietherapie (cART). Per jaar worden ongeveer 1000 nieuwe HIV-patiënten verwacht (Bron: SHM). Naast het vaste combinatiepreparaat doravirine/lamivudine/tenofovirdisoproxil is doravirine ook beschikbaar als mono preparaat (bevat doravirine als enige werkzame stof). De werkgroep verwacht een beperkte inzet voor de vaste combinatie van doravirine/lamivudine/tenofovirdisoproxil. Schatting: maximaal 200 patiënten.

Expected cost per patient per year

Cost 9,600.00 - 12,000.00
Additional remarks In dezelfde orde grootte als huidige STRs die varieren tussen de 800 en 1000 euro per maand (gelijke kosten verwacht).

Potential total cost per year

Total cost

2,160,000.00

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.