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 name:
- tocilizumab (RoActemra)
- SMC ID:
- 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