upadacitinib (Rinvoq)

following a full submission assessed under the orphan equivalent medicine process:

upadacitinib (Rinvoq®) is accepted for restricted use within NHSScotland.

Indication under review: for the treatment of giant cell arteritis in adult patients.

SMC restriction: for use in patients where tocilizumab is unsuitable, not tolerated or has failed.

Evidence from a double‑blind phase III study demonstrated that upadacitinib combined with a 26‑week corticosteroid taper was superior to placebo combined with a 52‑week corticosteroid taper, in achieving sustained remission at 52 weeks. Indirect comparisons of upadacitinib and tocilizumab (both combined with a 26‑week corticosteroid taper), were uncertain.

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.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.