insulin degludec (Tresiba)

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

insulin degludec (Tresiba) is not recommended for use within NHSScotland.

Indication under review: Treatment of diabetes mellitus in adolescents and children from the age of 1 year.

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

SMC previously assessed insulin degludec (Tresiba) for the treatment of diabetes mellitus in adults (856/13) and advised that it is not recommended for 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.