Doravirine / lamivudine / tenofovir disoproxil (fumarate) Medicine 12 June 2018 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. 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. Current proprietary name Already available biosimilars / generics Proprietary name Delstrigo Manufacturer MSD Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise 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 Unknown ATMP Unknown Submission date December 2017 Expected Registration November 2018 Orphan drug No Registration phase Registered Reimbursement Medicine sluice 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 This assessment does not indicate any potential inclusion in the package. 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 Frequency of administration 1 times a day Dosage per administration 100/300/300 mg References clinicaltrials.gov, NCT02397096 Additional remarks Expected patient volume per year Patient volume < 200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice 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 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 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 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References SPS Additional remarks Other information Additional remarks