filgotinib (Jyseleca)

following a resubmission:

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

Indication under review: 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.

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 combination with methotrexate or as monotherapy when methotrexate is contraindicated.

In a post hoc subgroup analysis from a phase III study, filgotinib compared with placebo (in combination with methotrexate) improved the signs and symptoms of moderate rheumatoid arthritis (DAS28[CRP] >3.2 to ≤5.1) in patients with an inadequate response to conventional DMARDs.

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 filgotinib in patients with severe disease (DAS28 greater than 5.1).