Dolutegravir / lamivudine Medicine 13 December 2018 Extended indication Treatment of Human Immunodeficiency Virus type 1 (HIV-1) Therapeutic value Possible equal value Total cost € 41,040,000.00 Registration phase Registration application pending Product Active substance Dolutegravir / lamivudine Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Viral infections other Extended indication Treatment of Human Immunodeficiency Virus type 1 (HIV-1) Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer ViiV Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks HIV integrase inhibitor + nucleoside reverse transcriptase inhibitor (NRTI) Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP Unknown Submission date October 2018 Expected Registration November 2019 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Nieuwe formulering (single tablet regimen) van 2 bestaande losse componenten. Therapeutic value Current treatment options Tenofovir/ emtricitabine/ dolutegravir Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Verwachte waarde duo therapie vergelijkbaar met triple therapie. Verwacht dat de duo therapie minder toxisch is. Non-inferior in vergelijking met tenofovir/ emtricitabine/ dolutegravir. Duration of treatment Frequency of administration 1 times a day Dosage per administration References Additional remarks Expected patient volume per year Patient volume < 3,800 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 19.035 betreft de patiëntenpopulatie die met HIV die behandeld wordt. Deze behandeling met twee geneesmiddelen gaat ongetwijfeld ook in de switch worden ingezet. Per jaar worden 1.000 nieuwe HIV-patiënten verwacht. Maximaal verwacht marktaandeel is 20 %. 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 behandelopties die variëren tussen de €800,00 - €1.000,00 per maand (gelijke kosten verwacht). Mogelijke kosten besparing (van 3 geneesmiddelen naar 2). De kans bestaat dat dit middel bestaande middelen vervangt (relevant voor BI). Potential total cost per year Total cost € 41,040,000.00 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