baricitinib (Olumiant)

following a full submission:

baricitinib (Olumiant®) is accepted for restricted use within NHS Scotland.

Indication under review: 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). Baricitinib may be used as monotherapy or in combination with methotrexate.

SMC restriction: In patients with severe disease (a disease activity score [DAS28] greater than 5.1) that has not responded to intensive therapy with a combination of conventional DMARDs. In patients with severe disease inadequately controlled by a TNF antagonist, it may be used in patients ineligible to receive rituximab.

Baricitinib, compared with placebo and with a tumour necrosis factor (TNF) antagonist, significantly improved signs and symptoms of RA in patients with an inadequate response to conventional DMARDs and, compared with placebo, in patients who had an inadequate response to a TNF antagonist.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of baricitinib. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.