in the absence of a submission from the holder of the marketing authorisation:

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide (Genvoya®) is not recommended for use within NHSScotland.

Indication under review: Treatment of human immunodeficiency virus-1 (HIV-1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir in children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities.

The holder of the marketing authorisation has not made a submission to SMC regarding this product in this setting.  As a result we cannot recommend its use within NHSScotland.

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From January 2020, ADTCs may make formulary decisions on paediatric licence extensions for medicines previously accepted for use (or restricted use) for the corresponding indication in adults, taking account of relevant restrictions. This approach may also be applied retrospectively to medicines accepted for use in adults but not recommended in the corresponding indication in children due to absence of submission. PASAG liaises with companies to extend any PAS to include the younger age group and confirms arrangements with Boards.