Doravirine / lamivudine / tenofovirdisoproxil Medicine 07 December 2021 Extended indication Extension of indication to include the new indication to the paediatric population weighing less than 35 kgs for PIFELTRO and DELSTRIGO. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Doravirine / lamivudine / tenofovirdisoproxil Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Viral infections other Extended indication Extension of indication to include the new indication to the paediatric population weighing less than 35 kgs for PIFELTRO and DELSTRIGO. Current proprietary name Already available biosimilars / generics Proprietary name Delstrigo Manufacturer MSD Portfolio holder Mechanism of action HIV inhibitor 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 August 2021 Expected Registration June 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume 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). 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. Expected cost per patient per year Cost € > 6,000.00 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 medicijnkosten Additional remarks Doravirine / lamivudine / tenofovir disoproxil tablet100/300/245mg kost €17,68, uitgaande van 1 tablet per dag voor een 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 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