upadacitinib (Rinvoq)

following a resubmission:

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

Indication under review: for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Upadacitinib may be used as monotherapy or in combination with methotrexate.

SMC restriction: in adults with moderate disease (a disease activity score [DAS28] of 3.2 to 5.1) when intensive therapy with 2 or more conventional DMARDs has not controlled the disease well enough.

In a phase III randomised, placebo-controlled and active comparator study in patients who had an inadequate response to methotrexate, upadacitinib significantly improved the signs and symptoms of RA compared with placebo.

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.

SMC has issued separate advice for upadacitinib in patients with severe disease (DAS28 greater than 5.1).