following a full submission assessed under the orphan medicine process:

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

Indication under review: the treatment of Giant Cell Arteritis (GCA) in adult patients

SMC restriction: treatment with tocilizumab is subject to a 12 month clinical stopping rule.

A phase III study of patients with recently diagnosed or relapsed GCA reported superiority of tocilizumab plus 26-week glucocorticosteroid taper over placebo plus 26-week glucocorticosteroid taper for obtaining a sustained glucocorticosteroid-free remission of GCA at week 52.

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

This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.

Medicine details

Medicine name:
tocilizumab (RoActemra)
For the treatment of Giant Cell Arteritis (GCA) in adult patients.
Pharmaceutical company
BNF chapter
Musculoskeletal and joint diseases
Submission type
Full submission
Date advice published:
10 September 2018