Doravirine / lamivudine / tenofovirdisoproxil Medicine 07 December 2021 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. Therapeutic value No estimate possible yet Total cost € 654,000.00 Registration phase Positive CHMP opinion Product Active substance Doravirine / lamivudine / tenofovirdisoproxil Domain Infectious diseases Reason of inclusion Indication extension IND 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. 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 Positive CHMP opinion Reimbursement Medicine sluice 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 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 < 109 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice 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 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 € 654,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks