abatacept 125mg/mL solution for subcutaneous injection in a pre-filled syringe (Orencia®)

following an abbreviated submission:

abatacept 125mg/mL solution for subcutaneous injection (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.

SMC has previously accepted abatacept 250mg powder for concentrate for solution for infusion (Orencia) for restricted use in NHS Scotland for this indication. Abatacept 125mg/mL subcutaneous injection (Orencia) is more expensive on a mg-for-mg basis than abatacept 250mg powder for concentrate for solution for infusion.

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 in NHS Scotland or a list price that is equivalent or lower.