following a re-submission:

tocilizumab (RoActemra) is accepted for resticted use in NHS Scotland.

Indication under review: tocilizumab monotherapy is indicated in patients who are intolerant to methotrexate or where continued treatment with methotrexate is inappropriate 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.

SMC restriction: tocilizumab is restricted for use in accordance with British Society for Rheumatology guidance on prescribing TNFα blockers in adults with rheumatoid arthritis (2005).

In a randomised double-blind controlled study conducted in patients who were intolerant to methotrexate or for whom methotrexate was inappropriate tocilizumab monotherapy was superior to a TNF antagonist for several clinically relevant outcomes (DAS28 scores DAS28 remission ACR response rates).

This SMC advice takes account of the benefits of a Patient Access Scheme that improves the cost-effectiveness of tocilizumab. This SMC advice is contingent upon the availability of the Patient Access Scheme in NHS Scotland.

Download detailed advice164KB (PDF)


Medicine details

Medicine name:
tocilizumab (RoActemra)
for the treatment of monotherapy in rheumatoid arthritis (RA) when biologic combination with methotrexate (MTX) is inappropriate [e.g. due to intolerance to MTX].
Pharmaceutical company
BNF chapter
Musculoskeletal and joint diseases
Submission type
Date advice published:
10 September 2012