Doravirine Medicine 12 June 2018 Extended indication Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV-1 without past or present evidence of resistance to the NNRTI class. Therapeutic value Possible equal value Total cost € 9,450,000.00 Registration phase Registered and reimbursed Product Active substance Doravirine Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Viral infections other Extended indication Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV-1 without past or present evidence of resistance to the NNRTI class. Current proprietary name Already available biosimilars / generics Proprietary name Pifeltro 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 Non-nucleoside 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 and reimbursed 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 Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Doravirine in combinatie andere HIV-remmers is vergelijkbaar met de huidige behandelopties. Duration of treatment Frequency of administration 1 times a day Dosage per administration 100 mg References clinicaltrials.gov, NCT02275780 Additional remarks Expected patient volume per year Patient volume < 2,000 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. Doravirine is een mogelijk alternatief voor de bestaande non-nucleoside reverse-transcriptaseremmers (NNRTI). Doravirine moet toegevoegd worden aan andere antiretrovirale middelen om een cART te vormen. De schatting is in dat er maximaal 2.000 patiënten zullen worden gezet op dit middel. Naast dit monopreparaat met doravirine is ook een vast combinatiepreparaat beschikbaar met doravirine/lamivudine/tenofovirdisoproxil. Expected cost per patient per year Cost € 4,725.00 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.nl Additional remarks Doravirine tablet 100 mg kost € 14,46. Uitgaande van 1 tablet per dag gedurende een jaar zou dat neerkomen op € 5149,29 (incl. BTW) per patient per jaar. M.a.w. dit zou neerkomen op zo'n 4725 euro (excl. BTW). Potential total cost per year Total cost € 9,450,000.00 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