Reason for request

Inclusion

-


Clinical Benefit

Substantial

The actual benefit of the proprietary medicinal product ORENCIA solution for subcutaneous injection is substantial in moderate to severe active rheumatoid arthritis in adult patients who responded inadequately to previous therapy with one or more DMARDs including MTX or a TNF inhibitor.


Clinical Added Value

no clinical added value

As it has been demonstrated to be non-inferior to the solution for intravenous infusion, the Transparency Committee considers that ORENCIA solution for subcutaneous injection does not provide any improvement in actual benefit (level V, non-existent) in comparison with ORENCIA solution for intravenous infusion.