sarilumab (Kevzara)

following a full submission:

sarilumab (Kevzara®) is accepted for restricted use within NHS Scotland.

Indication under review: in combination with methotrexate for the treatment of moderately to severely 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). Sarilumab can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate.

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.

Sarilumab significantly improved signs and symptoms of rheumatoid arthritis compared with placebo and with a tumour necrosis factor (TNF) inhibitor in patients with an inadequate response to conventional DMARDs, and compared with placebo in patients with an inadequate response to TNF inhibitors.

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