Rilpivirine Medicine 03 December 2024 Extended indication Extension of indication to include in combination with cabotegravir injection, the treatment of adolescents (at least 12 years of age and weighing at least 35 kg) for Rekambys Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Rilpivirine Domain Infectious diseases Reason of inclusion Indication extension IND Main indication HIV Extended indication Extension of indication to include in combination with cabotegravir injection, the treatment of adolescents (at least 12 years of age and weighing at least 35 kg) for Rekambys Current proprietary name Already available biosimilars / generics Proprietary name Rekambys Manufacturer Janssen Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date June 2024 Expected Registration May 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks EMA-indiening in juni 2024, registratie geschat in mei 2025 aan de hand van een gemiddelde doorlooptijd van 10 maanden voor een indicatieuitbreiding. 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 NCT03497676 (IMPAACT 2017) Additional remarks Recommended Monthly Dosing Schedule: Initiate injections of CABENUVA (600mg of cabotegravir and 900mg of rilpivirine) on the last day of current antiretroviral therapy or oral lead-in and continue with injections of CABENUVA (400mg of cabotegravir and 600mg of rilpivirine) every month thereafter. Recommended Every-2-Month Dosing Schedule: Initiate injections of CABENUVA (600mg of cabotegravir and 900mg of rilpivirine) on the last day of current antiretroviral therapy or oral lead-in for 2 consecutive months and continue with injections of CABENUVA every 2 months thereafter. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References HIV Monitoring Report 2023. SHM. 2023 (1) Additional remarks Dit is de indicatieuitbreiding van de Rekambys+Vocabria long-acting injectable combinatie naar kinderen boven de 12 jaar oud die ten minste 35kg wegen. Er zijn ongeveer 90 kinderen in Nederland met HIV tussen de 12 en 18 jaar oud (1). Expected cost per patient per year Cost € < 5,525.00 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 (1) Additional remarks Rekambys injsusp mva 300mg/ml flacon 3ml + toebehoren: €501,89 (inclusief BTW) (1). Een maandelijks doseringsschema van Rekambys zal €5.525 (exclusief BTW) per patiënt per jaar kosten. 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