filgotinib (Jyseleca)

following a full submission:

filgotinib (Jyseleca®) is accepted for restricted use within NHSScotland.

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

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 and in patients with severe disease inadequately controlled by a TNF antagonist in whom rituximab is not appropriate.

In two phase III studies, filgotinib compared with placebo (both in combination with methotrexate), significantly improved signs and symptoms of rheumatoid arthritis in patients with an inadequate response to conventional or biologic DMARDs. Filgotinib was non-inferior to a biologic DMARD in patients who had an inadequate response to methotrexate.

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.