Cabotegravir Medicine 13 December 2018 Extended indication Vocabria will be available as film-coated tablets (30mg) and as a prolonged-release suspension for injection (400 and 600mg). The active substance of Vocabria is cabotegravir, a direct- acting antiviral (ATC code: J05AJ04) known as an integrase strand transfer inhibitor (INI). Cabotegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle. Vocabria is to be used in combination with Rekambys (rilpivirine), another long-acting antiretroviral. Therapeutic value No estimate possible yet Total cost € 2,700,000.00 Registration phase Registered and reimbursed Product Active substance Cabotegravir Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication HIV Extended indication Vocabria will be available as film-coated tablets (30mg) and as a prolonged-release suspension for injection (400 and 600mg). The active substance of Vocabria is cabotegravir, a direct- acting antiviral (ATC code: J05AJ04) known as an integrase strand transfer inhibitor (INI). Cabotegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle. Vocabria is to be used in combination with Rekambys (rilpivirine), another long-acting antiretroviral. Current proprietary name Already available biosimilars / generics Proprietary name Vocabria Manufacturer ViiV Portfolio holder Mechanism of action HIV inhibitor Route of administration Intramuscular Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Een orale toedieningsvorm (tablet) is ook in ontwikkeling. Long acting HIV remmer. HIV integrase inhibitor + non-nucleoside reverse transcriptase inhibitor (NNRTI). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date August 2019 Expected Registration December 2020 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in oktober 2020. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Eerste combinatietherapie die long acting is. Dit is goed voor de therapietrouw. Resistentie bij stoppen of staken behandeling is een risico. Non-inferieur ten opzichte van continueren orale medicatie. Dit is een uitkomst voor patiënten die moeite hebben met orale therapie. Vergt van patiënten daarentegen wel 6 ziekenhuisbezoeken per jaar in plaats van 2 bezoeken per jaar indien met orale medicatie behandeld wordt. Duration of treatment Frequency of administration 1 times every 8 weeks Dosage per administration References Scrip Additional remarks ATLAS trial met its primary endpoints in august 2018. Expected patient volume per year Patient volume 250 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). In 2019 waren er 580 nieuwe diagnoses van HIV. Gezien het switchen van bestaande patiënten en gezien niet iedere nieuwe patiënt in aanmerking komt voor dit geneesmiddel is de schatting dat er in de komende 2 jaar 500 patiënten in aanmerking komen voor deze behandeling. 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 van grootte als huidige STR's die variëren van €800 tot €1.000 per maand. Het regime van 4 à 8 weken in combi met rilpivirine betekent wel 2 intramusculaire injecties (6-12x per jaar in plaats van 2x per jaar ziekenhuisbezoeken). Mogelijk is er impact op het intramuraal budget door vaker bezoek aan de poli. De kosten bestaan grotendeels niet uit meerkosten maar uit vervanging van bestaande middelen (relevant voor budget impact). Potential total cost per year Total cost € 2,700,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Op termijn mogelijke indicatie-uitbreiding voor de preventie van HIV (fase 3 studie in de Verenigde Staten). References clinicaltrials.gov, https://www.sps.nhs.uk/medicines/cabotegravir/ Additional remarks Other information Additional remarks