abatacept (Orencia)

following a resubmission:

abatacept (Orencia) is accepted for restricted use within NHSScotland.

Indication under review: In combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs including methotrexate or a TNF-alpha inhibitor.

SMC restriction: abatacept is restricted for use in patients with active rheumatoid arthritis as measured by disease activity score (DAS28) greater than 5.1 confirmed on at least two occasions, 1 month apart.

In combination with methotrexate, abatacept reduced the progression of joint damage and improved physical function more than placebo in patients with moderate to severe rheumatoid arthritis who responded inadequately to previous therapy with methotrexate alone.

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