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Rilpivirine

Rekambys

Extended indication

Extension of indication to include in combination with cabotegravir injection, the treatment of adol

Therapeutic value

No estimate possible yet
Registration phase

Registration application pending

Product

Active substance

Rilpivirine
Domain

Infectious diseases
Reason of inclusion

Indication extension
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
Proprietary name

Rekambys
Manufacturer

Janssen
Budgetting framework

Extramural (GVS)

Registration

Registration route

Centralised (EMA)
Type of trajectory

Normal trajectory
ATMP

No
Submission date

June 2024
Expected Registration

May 2025
Orphan drug

No
Registration phase

Registration application pending
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
Duration of treatment

continuous
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

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
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

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.