cabotegravir (Apretude)

following a full submission:

cabotegravir (Apretude®) is accepted for restricted use within NHSScotland.

Indication under review: Cabotegravir prolonged-release injection: in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents, weighing at least 35 kg.

Cabotegravir tablets: in combination with safer sex practices for short term pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents, weighing at least 35 kg. Cabotegravir tablets may be used as:

• oral lead-in to assess tolerability of cabotegravir prior to administration of long acting cabotegravir injection.
• oral PrEP for individuals who will miss planned dosing with cabotegravir injection.

SMC restriction: Adults and adolescents (weighing at least 35kg) at high risk of sexually acquired HIV who are eligible for PrEP, including oral PrEP, but for whom oral PrEP is not appropriate to meet their HIV prevention needs.

Cabotegravir was superior to daily oral tenofovir disoproxil fumarate/emtricitabine in the reduction of incident HIV acquisitions in a phase IIb/III study in men who have sex with men and transgender women (HPTN 083) and in a phase III study in cisgender women (HPTN 084) at high risk of acquiring human immunodeficiency virus (HIV).

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.