tocilizumab (RoActemra®)

following a full submission:

tocilizumab (RoActemra®) is accepted  for restricted use within NHS Scotland.

Indication under review: In combination with methotrexate (MTX) for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have either responded inadequately to, or who were intolerant to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, tocilizumab can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Tocilizumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.

SMC restriction: tocilizumab is restricted to use in accordance with current eligibility and continuation rules for biologic therapies in rheumatoid arthritis.

A phase III, randomised, double-blind, parallel-group study in adult patients with rheumatoid arthritis demonstrated that subcutaneous tocilizumab was non-inferior to tocilizumab intravenous infusion for the primary outcome of proportion of patients who achieved an American College of Rheumatology 20% response.

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