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Doravirine / lamivudine / tenofovir disoproxil (fumarate)

Delstrigo

Extended indication Delstrigo is indicated for the treatment of adults infected with HIV-1 without past or present evide
Therapeutic value No judgement
Total cost 2,160,000.00
Registration phase Registered

Product

Active substance Doravirine / lamivudine / tenofovir disoproxil (fumarate)
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Viral infections other
Extended indication Delstrigo is indicated for the treatment of adults infected with HIV-1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir.
Proprietary name Delstrigo
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
Submission date December 2017
Expected Registration November 2018
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP-opinie september 2018. Geregistreerd in november 2018.

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 is de verwachting dat er meer bijwerkingen in vergelijking tot de huidige behandelopties zullen zijn.
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 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. Naast het vaste combinatiepreparaat doravirine/lamivudine/tenofovirdisoproxil is doravirine ook beschikbaar als mono preparaat (bevat doravirine als enige werkzame stof). De verwachting is 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 €800,00 - €1.000,00 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

Indication extension No
References SPS

Other information

There is currently no futher information available.